{"id":319,"date":"2026-04-02T15:44:14","date_gmt":"2026-04-02T06:44:14","guid":{"rendered":"https:\/\/rmnw.jp\/teams\/?p=319"},"modified":"2026-04-03T11:23:59","modified_gmt":"2026-04-03T02:23:59","slug":"2026%e3%80%80%e5%86%8d%e7%94%9f%e5%8c%bb%e7%99%82%e3%81%ae%e6%95%99%e7%a7%91%e6%9b%b8","status":"publish","type":"post","link":"https:\/\/rmnw.jp\/teams\/?p=319","title":{"rendered":"2026\u3000\u518d\u751f\u533b\u7642\u306e\u6559\u79d1\u66f8"},"content":{"rendered":"\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<iframe loading=\"lazy\" title=\"\u518d\u751f\u533b\u7642\uff1a\u4eba\u4f53\u3092\u518d\u69cb\u7bc9\u3059\u308b\u79d1\u5b66\" width=\"500\" height=\"281\" src=\"https:\/\/www.youtube.com\/embed\/v0XUPlKWj9Y?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" 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class=\"wp-block-heading\">\u518d\u751f\u533b\u7642\u30fb\u533b\u5e2b\u5411\u3051\u6559\u79d1\u66f8 \u5168\u30b3\u30f3\u30c6\u30f3\u30c4\uff08\u5f15\u7528\u4ed8\u304d\uff09<\/h1>\n\n\n\n<p><strong>\u7248\uff1a\u30d5\u30a1\u30af\u30c8\u30c1\u30a7\u30c3\u30af\u4fee\u6b63\u7248<\/strong><br>\u4f5c\u6210\u65e5\uff1a2026\u5e743\u670830\u65e5<br>\u5bfe\u8c61\u8aad\u8005\uff1a\u7d4c\u9a13\u8c4a\u5bcc\u306a\u533b\u5e2b\uff08\u533b\u7642\u6a5f\u95a2\u306e\u4ee3\u8868\u7406\u4e8b\u30ec\u30d9\u30eb\uff09<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u25a0 \u4fee\u6b63\u5c65\u6b74\uff08\u30d5\u30a1\u30af\u30c8\u30c1\u30a7\u30c3\u30af\u9069\u7528\u5206\uff09<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4fee\u6b63\u2460\uff08\u7b2c12\u7ae0\uff09\uff1aFDA CGT\u627f\u8a8d\u88fd\u54c1\u6570 47\u2192<strong>48\u88fd\u54c1<\/strong>\uff08\u51fa\u5178\uff1aFDA\u516c\u5f0f\u300cApproved Cellular and Gene Therapy 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class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u25a0 \u56fd\u5185\u5916\u306e\u4e3b\u8981\u6559\u79d1\u66f8\u304b\u3089\u8aad\u307f\u89e3\u304f\u69cb\u6210\u30d1\u30bf\u30fc\u30f3<\/h2>\n\n\n\n<p><strong>\u82f1\u8a9e\u570f\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>Principles of Regenerative Medicine<\/em>\uff08Atala, Lanza \u4ed6\u7de8\u3001\u7b2c3\u7248 2018\u5e74\u3001\u516862\u7ae0\uff09\uff1a\u300c\u5206\u5b50\u30fb\u7d30\u80de\u751f\u7269\u5b66\u57fa\u76e4\u2192\u5e79\u7d30\u80de\u5404\u8ad6\u2192\u30d0\u30a4\u30aa\u30de\u30c6\u30ea\u30a2\u30eb\u2192\u81d3\u5668\u5225\u81e8\u5e8a\u5fdc\u7528\u2192\u898f\u5236\u30fb\u502b\u7406\u300d\u306e5\u90e8\u69cb\u6210\u3092\u63a1\u7528\u3057\u3001\u30d9\u30f3\u30c1\u304b\u3089\u30d9\u30c3\u30c9\u30b5\u30a4\u30c9\u3078\u306e\u4e00\u65b9\u5411\u7684\u9032\u884c\u3092\u6a19\u6e96\u5316\u3057\u305f\u3002<\/li>\n\n\n\n<li><em>Regenerative Medicine: From Protocol to Patient<\/em>\uff08Steinhoff\u8457\u3001Springer\u3001\u51685\u5dfb\u30012024-2025\u5e74\u66f4\u65b0\u7ae0\u3042\u308a\uff09\uff1a\u540c\u69d8\u306e\u69cb\u6210\u3060\u304c\u3001\u3088\u308a\u8a73\u7d30\u306a\u57fa\u790e\u751f\u7269\u5b66\u3068\u81e8\u5e8a\u7642\u6cd5\u306b2\u5dfb\u3092\u5272\u304f\u62e1\u5f35\u578b\u3067\u3042\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<p><strong>\u65e5\u672c\u8a9e\u570f\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u65e5\u672c\u518d\u751f\u533b\u7642\u5b66\u4f1a\u76e3\u4fee\u300e\u30c6\u30ad\u30b9\u30c8\u30d6\u30c3\u30af\u518d\u751f\u533b\u7642\u300f\uff082019\u5e74\uff09\uff1a\u57fa\u790e\u79d1\u5b66\u3088\u308a\u3082\u6cd5\u4ee4\u30fb\u502b\u7406\u30fbCPC\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\u306e\u5b9f\u52d9\u306b\u91cd\u70b9\u3092\u7f6e\u304d\u3001\u518d\u751f\u533b\u7642\u7b49\u5b89\u5168\u6027\u78ba\u4fdd\u6cd5\u3078\u306e\u5b8c\u5168\u5bfe\u5fdc\u3092\u7279\u5fb4\u3068\u3059\u308b\u3002<\/li>\n\n\n\n<li>\u9577\u8239\u5065\u4e8c\u8457\u300e\u6539\u8a02\u7248 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\u771f\u306e\u5b9f\u81e8\u5e8a\u5fdc\u7528\u3092\u3081\u3056\u3057\u305f\u518d\u751f\u533b\u7642\u300f\uff1a\u300c\u793e\u4f1a\u3068\u306e\u95a2\u308f\u308a\u2192\u6280\u8853\u958b\u767a\u30fb\u898f\u5236\u2192\u65b0\u898f\u6280\u8853\u2192\u81e8\u5e8a\u5fdc\u7528\u2192\u7523\u696d\u5316\u300d\u306e5\u7ae0\u69cb\u6210\u3067\u3001\u7ffb\u8a33\u7814\u7a76\u30fb\u793e\u4f1a\u5b9f\u88c5\u306e\u8996\u70b9\u3092\u6700\u3082\u5f37\u304f\u53cd\u6620\u3057\u3066\u3044\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u25a0 \u63d0\u6848\u3059\u308b\u6559\u79d1\u66f8\u69cb\u6210\uff1a\u51686\u90e8\u30fb30\u7ae0<\/h2>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u7b2c\u2160\u90e8\u3000\u518d\u751f\u533b\u7642\u306e\u57fa\u76e4\uff08\u7b2c1\uff5e6\u7ae0\uff09<\/h2>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c1\u7ae0\u3000\u518d\u751f\u533b\u7642\u306e\u6b74\u53f2\u3068\u5c55\u671b\u2015\u2015\u9aa8\u9ac4\u79fb\u690d\u304b\u3089iPS\u7d30\u80de\u627f\u8a8d\u307e\u3067<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>\u518d\u751f\u533b\u7642\u306e\u5b9a\u7fa9\u3001\u6b74\u53f2\u7684\u767a\u5c55\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u898f\u6a21\u3001\u65e5\u672c\u306e\u30dd\u30b8\u30b7\u30e7\u30cb\u30f3\u30b0\u3002\u5bfe\u8c61\u8aad\u8005\u306e\u81e8\u5e8a\u7d4c\u9a13\u3092\u524d\u63d0\u306b\u3001\u6982\u8ad6\u306f\u7c21\u6f54\u306b\u307e\u3068\u3081\u3001\u672c\u66f8\u5168\u4f53\u306e\u30ed\u30fc\u30c9\u30de\u30c3\u30d7\u3092\u793a\u3059\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u6b74\u53f2\u7684\u767a\u5c55\u7cfb\u8b5c<\/strong><\/li>\n\n\n\n<li>1956\u5e74\uff1a\u9aa8\u9ac4\u79fb\u690d\uff08E. Donnall Thomas\u3001\u5f8c\u306b\u30ce\u30fc\u30d9\u30eb\u8cde\u53d7\u8cde\uff09<\/li>\n\n\n\n<li>1998\u5e74\uff1a\u30d2\u30c8ES\u7d30\u80de\u6a39\u7acb\uff08Thomson, Science 1998\uff09<\/li>\n\n\n\n<li>2006\u5e74\uff1a\u30de\u30a6\u30b9iPS\u7d30\u80de\u6a39\u7acb\uff08\u5c71\u4e2d\u4f38\u5f25\u3001Cell 2006\uff09<\/li>\n\n\n\n<li>2007\u5e74\uff1a\u30d2\u30c8iPS\u7d30\u80de\u6a39\u7acb\uff08\u5c71\u4e2d\u4f38\u5f25\u3001Cell 2007 \u2192 2012\u5e74\u30ce\u30fc\u30d9\u30eb\u751f\u7406\u5b66\u30fb\u533b\u5b66\u8cde\uff09<\/li>\n\n\n\n<li>2014\u5e74\uff1a\u518d\u751f\u533b\u7642\u7b49\u5b89\u5168\u6027\u78ba\u4fdd\u6cd5\u30fb\u85ac\u6a5f\u6cd5 \u540c\u6642\u65bd\u884c<\/li>\n\n\n\n<li>2014\u5e74\uff1aRIKEN \u9ad8\u6a4b\u653f\u4ee3\u535a\u58eb\u3001\u4e16\u754c\u521d\u306eiPSC\u7531\u6765RPE\u7d30\u80de\u30b7\u30fc\u30c8\u79fb\u690d<\/li>\n\n\n\n<li>2026\u5e74\uff1aiPS\u7d30\u80de\u7531\u6765\u88fd\u54c12\u54c1\u76ee \u4e16\u754c\u521d\u306e\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d<\/li>\n\n\n\n<li><strong>\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u898f\u6a21<\/strong>\uff08\u51fa\u5178\uff1aFortune Business Insights\u63a8\u8a08\uff09<\/li>\n\n\n\n<li>2025\u5e74\uff1a\u7d04516.5\u5104\u30c9\u30eb<\/li>\n\n\n\n<li>2034\u5e74\uff1a\u7d045,555.8\u5104\u30c9\u30eb<\/li>\n\n\n\n<li>CAGR\uff1a31.27%<\/li>\n\n\n\n<li>\u203b\u672c\u6570\u5024\u306fFortune Business Insights\u63a8\u8a08\u3067\u3042\u308a\u3001\u8abf\u67fb\u4f1a\u793e\u3054\u3068\u306b\u5b9a\u7fa9\u30fb\u7bc4\u56f2\u304c\u7570\u306a\u308b\u305f\u3081\u3001\u6bd4\u8f03\u306e\u969b\u306f\u51fa\u5178\u3092\u660e\u793a\u3059\u308b\u3053\u3068\u3002<\/li>\n\n\n\n<li><strong>\u65e5\u672c\u306e\u30dd\u30b8\u30b7\u30e7\u30cb\u30f3\u30b0<\/strong><\/li>\n\n\n\n<li>\u4e16\u754c\u521d\u306eiPSC\u7531\u6765\u6cbb\u7642\u88fd\u54c1\u627f\u8a8d\u56fd\uff082026\u5e743\u67086\u65e5\uff09<\/li>\n\n\n\n<li>\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d\u5236\u5ea6\u3068\u3044\u3046\u72ec\u81ea\u306e\u65e9\u671f\u627f\u8a8d\u30d1\u30b9\u3092\u6709\u3059\u308b<\/li>\n\n\n\n<li>\u65e5\u672c\u56fa\u6709\u306e\u4e8c\u5143\u7684\u898f\u5236\u4f53\u5236\uff08\u5b89\u78ba\u6cd5\uff0b\u85ac\u6a5f\u6cd5\uff09<\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Fortune Business Insights. <em>Regenerative Medicine Market Size, Share &amp; COVID-19 Impact Analysis<\/em>. URL: <a href=\"https:\/\/www.fortunebusinessinsights.com\/industry-reports\/regenerative-medicine-market-100970\">https:\/\/www.fortunebusinessinsights.com\/industry-reports\/regenerative-medicine-market-100970<\/a><\/li>\n\n\n\n<li>\u539a\u751f\u52b4\u50cd\u7701. \u518d\u751f\u533b\u7642\u7b49\u306e\u5b89\u5168\u6027\u306e\u78ba\u4fdd\u7b49\u306b\u95a2\u3059\u308b\u6cd5\u5f8b. 2014\u5e7411\u670825\u65e5\u65bd\u884c. URL: <a href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000150542_00016.html\">https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000150542_00016.html<\/a><\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c2\u7ae0\u3000\u5e79\u7d30\u80de\u751f\u7269\u5b66\u306e\u57fa\u790e\u2015\u2015\u81ea\u5df1\u8907\u88fd\u30fb\u591a\u80fd\u6027\u30fb\u30cb\u30c3\u30c1\u306e\u5206\u5b50\u6a5f\u69cb<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>\u5e79\u7d30\u80de\u306e\u5b9a\u7fa9\u3068\u5206\u985e\u3001\u81ea\u5df1\u8907\u88fd\u3068\u975e\u5bfe\u79f0\u5206\u88c2\u3001\u591a\u80fd\u6027\u306e\u5206\u5b50\u56de\u8def\u3001\u5e79\u7d30\u80de\u30cb\u30c3\u30c1\u306e\u6982\u5ff5\u3001\u30a8\u30d4\u30b8\u30a7\u30cd\u30c6\u30a3\u30af\u30b9\u3002\u81e8\u5e8a\u533b\u5411\u3051\u306b\u81e8\u5e8a\u7684\u610f\u7fa9\u3092\u5f37\u8abf\u3059\u308b\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u5e79\u7d30\u80de\u306e\u5b9a\u7fa9\u3068\u5206\u985e<\/strong><\/li>\n\n\n\n<li>\u5168\u80fd\u6027\uff08\u53d7\u7cbe\u5375\u30fb2\u7d30\u80de\u671f\uff09<\/li>\n\n\n\n<li>\u591a\u80fd\u6027\uff08ES\u7d30\u80de\u3001iPS\u7d30\u80de\uff09<\/li>\n\n\n\n<li>\u591a\u5206\u5316\u80fd\uff08\u9020\u8840\u5e79\u7d30\u80de\u3001MSC\u306a\u3069\u7d44\u7e54\u5e79\u7d30\u80de\uff09<\/li>\n\n\n\n<li>\u5358\u5206\u5316\u80fd\uff08\u7d44\u7e54\u7279\u7570\u7684\u524d\u99c6\u7d30\u80de\uff09<\/li>\n\n\n\n<li>\u304c\u3093\u5e79\u7d30\u80de\uff08cancer stem cell\uff09\u306e\u6982\u5ff5<\/li>\n\n\n\n<li><strong>\u591a\u80fd\u6027\u306e\u5206\u5b50\u56de\u8def<\/strong><\/li>\n\n\n\n<li>\u30b3\u30a2\u30c8\u30e9\u30f3\u30b9\u30af\u30ea\u30d7\u30b7\u30e7\u30f3\u30d5\u30a1\u30af\u30bf\u30fc\uff1aOct3\/4\uff08POU5F1\uff09\u3001Sox2\u3001Nanog<\/li>\n\n\n\n<li>\u5c71\u4e2d\u56e0\u5b50\uff1aOct3\/4\u3001Sox2\u3001Klf4\u3001c-Myc\uff08iPS\u7d30\u80de\u8a98\u5c0e\uff09<\/li>\n\n\n\n<li>\u591a\u80fd\u6027\u7dad\u6301\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u306e\u76f8\u4e92\u8abf\u7bc0<\/li>\n\n\n\n<li>\u30a8\u30d4\u30b8\u30a7\u30cd\u30c6\u30a3\u30af\u30b9\uff1aDNA\u30e1\u30c1\u30eb\u5316\u3001\u30d2\u30b9\u30c8\u30f3\u4fee\u98fe\u3001\u30af\u30ed\u30de\u30c1\u30f3\u30ea\u30e2\u30c7\u30ea\u30f3\u30b0<\/li>\n\n\n\n<li><strong>\u5e79\u7d30\u80de\u30cb\u30c3\u30c1<\/strong><\/li>\n\n\n\n<li>\u6a5f\u68b0\u7684\u30b7\u30b0\u30ca\u30eb\uff08\u57fa\u8cea\u786c\u5ea6\u3001\u7269\u7406\u7684\u5f35\u529b\uff09<\/li>\n\n\n\n<li>\u5316\u5b66\u7684\u30b7\u30b0\u30ca\u30eb\uff08\u5897\u6b96\u56e0\u5b50\u3001\u30b5\u30a4\u30c8\u30ab\u30a4\u30f3\u3001\u9178\u7d20\u6fc3\u5ea6\uff09<\/li>\n\n\n\n<li>\u4f4d\u76f8\u7684\u30b7\u30b0\u30ca\u30eb\uff08\u7d30\u80de\u9593\u63a5\u89e6\u30013\u6b21\u5143\u69cb\u9020\uff09<\/li>\n\n\n\n<li>\u9aa8\u9ac4\u30cb\u30c3\u30c1\uff08\u9020\u8840\u5e79\u7d30\u80de\uff09\u3001\u8178\u7ba1\u30af\u30ea\u30d7\u30c8\uff08\u8178\u7ba1\u5e79\u7d30\u80de\uff09<\/li>\n\n\n\n<li><strong>\u81ea\u5df1\u8907\u88fd\u3068\u975e\u5bfe\u79f0\u5206\u88c2<\/strong><\/li>\n\n\n\n<li>\u5bfe\u79f0\u5206\u88c2\uff08\u5e79\u7d30\u80de\u30d7\u30fc\u30eb\u306e\u62e1\u5927\uff09vs \u975e\u5bfe\u79f0\u5206\u88c2\uff08\u5206\u5316\u3068\u7dad\u6301\u306e\u4e21\u7acb\uff09<\/li>\n\n\n\n<li>Notch\u3001Wnt\u3001Hedgehog\u30b7\u30b0\u30ca\u30eb\u306b\u3088\u308b\u5236\u5fa1<\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>Principles of Regenerative Medicine<\/em>, 3rd ed., Atala A, Lanza R, et al., Academic Press, 2018.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c3\u7ae0\u3000ES\u7d30\u80de\u30fbiPS\u7d30\u80de\u2015\u2015\u6a39\u7acb\u304b\u3089\u81e8\u5e8a\u30b0\u30ec\u30fc\u30c9\u88fd\u9020\u307e\u3067<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>ES\u7d30\u80de\u306e\u6a39\u7acb\u30fb\u57f9\u990a\u30fb\u5206\u5316\u8a98\u5c0e\u6cd5\u3001iPS\u7d30\u80de\u306e\u30ea\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u6a5f\u69cb\u3001\u30ca\u30a4\u30fc\u30d6\u578b\u3068\u30d7\u30e9\u30a4\u30e0\u578b\u306e\u533a\u5225\u3001\u30b2\u30ce\u30e0\u5b89\u5b9a\u6027\u306e\u8ab2\u984c\u3001\u81e8\u5e8a\u30b0\u30ec\u30fc\u30c9iPS\u7d30\u80de\u30d0\u30f3\u30af\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>ES\u7d30\u80de\uff08\u80da\u6027\u5e79\u7d30\u80de\uff09<\/strong><\/li>\n\n\n\n<li>\u7531\u6765\uff1a\u53d7\u7cbe\u5f8c5\uff5e6\u65e5\u306e\u80da\u76e4\u80de\u306e\u5185\u90e8\u7d30\u80de\u584a\uff08ICM\uff09<\/li>\n\n\n\n<li>1998\u5e74\uff1aThomson\uff08Science\uff09\u306b\u3088\u308b\u30d2\u30c8ES\u7d30\u80de\u306e\u521d\u6a39\u7acb<\/li>\n\n\n\n<li>\u7121\u9650\u5897\u6b96\u80fd\u3068\u591a\u80fd\u6027\u306e\u7dad\u6301<\/li>\n\n\n\n<li>\u502b\u7406\u7684\u8ab2\u984c\uff1a\u30d2\u30c8\u80da\u306e\u4f7f\u7528\uff08\u5f8c\u8ff0 \u7b2c24\u7ae0\u53c2\u7167\uff09<\/li>\n\n\n\n<li><strong>iPS\u7d30\u80de\uff08\u4eba\u5de5\u591a\u80fd\u6027\u5e79\u7d30\u80de\uff09<\/strong><\/li>\n\n\n\n<li>2006\u5e74\uff08\u5c71\u4e2d\u4f38\u5f25\u3001Cell 2006\uff09\uff1a\u30de\u30a6\u30b9\u7dda\u7dad\u82bd\u7d30\u80de\u304b\u3089\u306e\u8a98\u5c0e<\/li>\n\n\n\n<li>2007\u5e74\uff08\u5c71\u4e2d\u4f38\u5f25\u3001Cell 2007\uff09\uff1a\u30d2\u30c8iPS\u7d30\u80de\u306e\u6a39\u7acb<\/li>\n\n\n\n<li>\u5c71\u4e2d\u56e0\u5b50\uff08Oct3\/4\u3001Sox2\u3001Klf4\u3001c-Myc\uff09\u306b\u3088\u308b\u30ea\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0<\/li>\n\n\n\n<li>\u30a6\u30a4\u30eb\u30b9\u30d5\u30ea\u30fc\u30fb\u30a8\u30d4\u30bd\u30fc\u30de\u30eb\u30d9\u30af\u30bf\u30fc\u306b\u3088\u308b\u5b89\u5168\u306a\u8a98\u5c0e\u6cd5<\/li>\n\n\n\n<li><strong>\u30ca\u30a4\u30fc\u30d6\u578b\u3068\u30d7\u30e9\u30a4\u30e0\u578b<\/strong><\/li>\n\n\n\n<li>\u30ca\u30a4\u30fc\u30d6\u578b\uff1a\u80da\u76e4\u8449\u671f\u306b\u76f8\u5f53\u3001\u3088\u308a\u672a\u5206\u5316\uff08\u30de\u30a6\u30b9ES\u7d30\u80de\u306b\u8fd1\u3044\uff09<\/li>\n\n\n\n<li>\u30d7\u30e9\u30a4\u30e0\u578b\uff1a\u30a8\u30d4\u30d6\u30e9\u30b9\u30c8\u671f\u306b\u76f8\u5f53\u3001\u30d2\u30c8ES\/iPS\u7d30\u80de\u306e\u6a19\u6e96\u7684\u72b6\u614b<\/li>\n\n\n\n<li>\u81e8\u5e8a\u5fdc\u7528\u306b\u304a\u3044\u3066\u306f\u30d7\u30e9\u30a4\u30e0\u578b\u304c\u4e3b\u6d41<\/li>\n\n\n\n<li><strong>\u30b2\u30ce\u30e0\u5b89\u5b9a\u6027\u306e\u8ab2\u984c<\/strong><\/li>\n\n\n\n<li>\u30ea\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u904e\u7a0b\u3067\u306e\u4f53\u7d30\u80de\u5909\u7570\u306e\u84c4\u7a4d<\/li>\n\n\n\n<li>\u30b3\u30d4\u30fc\u6570\u5909\u7570\uff08CNV\uff09\u3001\u70b9\u7a81\u7136\u5909\u7570\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0<\/li>\n\n\n\n<li>\u5168\u30b2\u30ce\u30e0\u30b7\u30fc\u30b1\u30f3\u30b7\u30f3\u30b0\u306b\u3088\u308b\u54c1\u8cea\u7ba1\u7406\u306e\u91cd\u8981\u6027<\/li>\n\n\n\n<li><strong>\u81e8\u5e8a\u30b0\u30ec\u30fc\u30c9iPS\u7d30\u80de\u30d0\u30f3\u30af<\/strong><\/li>\n\n\n\n<li>CiRA Foundation iPS\u7d30\u80de\u30b9\u30c8\u30c3\u30af\u4e8b\u696d\uff08\u4eac\u90fd\u5927\u5b66\uff09<\/li>\n\n\n\n<li>HLA\u30db\u30e2\u63a5\u5408\u4f53\u30c9\u30ca\u30fc\u304b\u3089\u306e\u4f9b\u7d66\u4f53\u5236<\/li>\n\n\n\n<li>17\u7a2e\u306eHLA\u30db\u30e2\u63a5\u5408\u4f53iPSC\u3067\u65e5\u672c\u4eba\u53e3\u306e\u5927\u90e8\u5206\u3092\u30ab\u30d0\u30fc\u53ef\u80fd<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aCiRA Foundation. https:\/\/www.cira.kyoto-u.ac.jp\/e\/research\/stock.html<\/li>\n\n\n\n<li><strong>hPSC\u81e8\u5e8a\u8a66\u9a13\u306e\u73fe\u72b6<\/strong>\uff08as of December 2024\uff09<\/li>\n\n\n\n<li>\u4e16\u754c\u3067115\u4ef6\u306ehPSC\u81e8\u5e8a\u8a66\u9a13\u304c\u9032\u884c\u4e2d<\/li>\n\n\n\n<li>83\u88fd\u54c1\u304c\u8a66\u9a13\u6bb5\u968e<\/li>\n\n\n\n<li>1,200\u4eba\u4ee5\u4e0a\u306b\u6295\u4e0e<\/li>\n\n\n\n<li>\u30c6\u30e9\u30c8\u30fc\u30de\u5f62\u6210\u306a\u3069\u306e\u300c\u4e00\u822c\u5316\u3055\u308c\u305f\u5b89\u5168\u6027\u61f8\u5ff5\u306f\u5831\u544a\u3055\u308c\u3066\u3044\u306a\u3044\u300d<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aKirkeby A, Main H, Carpenter M, et al. Pluripotent stem-cell-derived therapies in clinical trial: A 2025 update. <em>Cell Stem Cell<\/em>. 2025;32(1):10-37. DOI: 10.1016\/j.stem.2024.12.005. URL: <a href=\"https:\/\/www.cell.com\/cell-stem-cell\/fulltext\/S1934-5909(24)00445-4\">https:\/\/www.cell.com\/cell-stem-cell\/fulltext\/S1934-5909(24)00445-4<\/a><\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Thomson JA, et al. Embryonic Stem Cell Lines Derived from Human Blastocysts. <em>Science<\/em>. 1998;282(5391):1145-1147.<\/li>\n\n\n\n<li>Takahashi K, Yamanaka S. Induction of Pluripotent Stem Cells from Mouse Embryonic and Adult Fibroblast Cultures by Defined Factors. <em>Cell<\/em>. 2006;126(4):663-676.<\/li>\n\n\n\n<li>Kirkeby et al. 2025, <em>Cell Stem Cell<\/em>, as cited above.<\/li>\n\n\n\n<li>CiRA Foundation. iPS Cell Stock for Regenerative Medicine. URL: <a href=\"https:\/\/www.cira.kyoto-u.ac.jp\/e\/research\/stock.html\">https:\/\/www.cira.kyoto-u.ac.jp\/e\/research\/stock.html<\/a><\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c4\u7ae0\u3000\u7d44\u7e54\u5e79\u7d30\u80de\u3068\u4f53\u6027\u5e79\u7d30\u80de\u2015\u2015\u9020\u8840\u5e79\u7d30\u80de\u30fbMSC\u30fb\u795e\u7d4c\u5e79\u7d30\u80de\u30fb\u305d\u306e\u4ed6<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>\u9020\u8840\u5e79\u7d30\u80de\u306e\u751f\u7269\u5b66\u3068\u81e8\u5e8a\u7684\u610f\u7fa9\u3001\u9593\u8449\u7cfb\u5e79\u7d30\u80de\uff08MSC\uff09\u306e\u5b9a\u7fa9\u3068\u7531\u6765\u5225\u7279\u6027\u3001\u795e\u7d4c\u5e79\u7d30\u80de\u3001\u76ae\u819a\u30fb\u6bdb\u5305\u5e79\u7d30\u80de\u3001\u8178\u7ba1\u5e79\u7d30\u80de\u3001\u5fc3\u7b4b\u524d\u99c6\u7d30\u80de\u3001\u809d\u524d\u99c6\u7d30\u80de\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u9020\u8840\u5e79\u7d30\u80de\uff08HSC\uff09<\/strong><\/li>\n\n\n\n<li>\u9aa8\u9ac4\u3001\u672b\u68a2\u8840\u3001\u81cd\u5e2f\u8840\u304b\u3089\u306e\u63a1\u53d6<\/li>\n\n\n\n<li>1956\u5e74\uff1aE. Donnall Thomas\u306b\u3088\u308b\u521d\u306e\u9aa8\u9ac4\u79fb\u690d<\/li>\n\n\n\n<li>\u5168\u9020\u8840\u7cfb\u306e\u9577\u671f\u518d\u69cb\u7bc9\u80fd<\/li>\n\n\n\n<li>\u81e8\u5e8a\u5fdc\u7528\uff1a\u767d\u8840\u75c5\u3001\u30ea\u30f3\u30d1\u816b\u3001\u518d\u751f\u4e0d\u826f\u6027\u8ca7\u8840\u3001\u514d\u75ab\u4e0d\u5168\u75be\u60a3<\/li>\n\n\n\n<li><strong>\u9593\u8449\u7cfb\u5e79\u7d30\u80de\uff08MSC\uff09<\/strong><\/li>\n\n\n\n<li>\u56fd\u969b\u7d30\u80de\u6cbb\u7642\u5b66\u4f1a\uff08ISCT\uff09\u306e\u5b9a\u7fa9\u57fa\u6e96\uff082006\u5e74\uff09\uff1a\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u63a5\u7740\u6027\u3001CD105\u30fbCD73\u30fbCD90\u967d\u6027\u3001CD45\u30fbCD34\u30fbCD11b\u30fbCD79\u03b1\u30fbHLA-DR\u9670\u6027\u3001\u9aa8\u82bd\u30fb\u8edf\u9aa8\u30fb\u8102\u80aa\u3078\u306e\u4e09\u5206\u5316\u80fd<\/li>\n\n\n\n<li>\u7531\u6765\u5225\u7279\u6027\uff1a\u9aa8\u9ac4MSC\u3001\u8102\u80aa\u7531\u6765MSC\uff08ADSC\uff09\u3001\u81cd\u5e2fMSC\u3001\u6b6f\u9ac4\u5e79\u7d30\u80de\uff08DPSC\uff09<\/li>\n\n\n\n<li>\u514d\u75ab\u8abf\u7bc0\u4f5c\u7528\uff08\u514d\u75ab\u6291\u5236\u30fb\u6297\u708e\u75c7\uff09<\/li>\n\n\n\n<li>\u5206\u6ccc\u56e0\u5b50\uff08\u30d1\u30e9\u30af\u30e9\u30a4\u30f3\uff09\u306b\u3088\u308b\u9593\u63a5\u7684\u6cbb\u7642\u52b9\u679c<\/li>\n\n\n\n<li><strong>MSC\u81e8\u5e8a\u8a66\u9a13\u306e\u73fe\u72b6<\/strong>\uff08\u4e00\u6b21\u60c5\u5831\u6e90\u306b\u57fa\u3065\u304f\u5024\uff09<\/li>\n\n\n\n<li>Lu et al. 2025\uff08<em>Molecular Therapy<\/em>\uff09\u306b\u3088\u308bClinicalTrials.gov\u306e\u76f4\u63a5\u691c\u7d22\uff1a\u300cmesenchymal stem cells\u300d1,506\u4ef6\u30fb\u300cmesenchymal stromal cells\u300d567\u4ef6\uff082024\u5e7410\u6708\u6642\u70b9\u3001\u91cd\u8907\u3042\u308a\uff09<\/li>\n\n\n\n<li>Shan et al. 2024\uff08<em>Signal Transduction and Targeted Therapy<\/em>\uff09\uff1a\u300c1,600\u4ef6\u4ee5\u4e0a\u300d<\/li>\n\n\n\n<li>\u627f\u8a8d\u88fd\u54c1\uff1a\u56fd\u969b\u7684\u306b\u306f10\u88fd\u54c1\u524d\u5f8c\u304c\u6b63\u5f0f\u627f\u8a8d\uff08Ryoncil\u3008\u7c73\u56fd\u30012024\u5e7412\u6708FDA\u627f\u8a8d\u3009\u3001\u30c6\u30e0\u30bb\u30eb\u3008\u65e5\u672c\u3009\u3001Alofisel\/darvadstrocel\u3008\u65e5\u672c\u3009\u7b49\uff09<\/li>\n\n\n\n<li>\u203b\u6ce8\u610f\uff1aMSC\u306e\u81e8\u5e8a\u8a66\u9a13\u4ef6\u6570\u30fb\u627f\u8a8d\u88fd\u54c1\u6570\u306f\u3001\u8a08\u6570\u65b9\u6cd5\uff08\u91cd\u8907\u9664\u53bb\u306e\u6709\u7121\u3001\u627f\u8a8d\u306e\u5b9a\u7fa9\u3001\u5bfe\u8c61\u56fd\uff09\u306b\u3088\u3063\u3066\u5909\u52d5\u3059\u308b\u3002\u5546\u696d\u8abf\u67fb\u4f1a\u793e\u63a8\u8a08\uff08ResearchAndMarkets\u306a\u3069\uff09\u3092\u6839\u62e0\u3068\u3057\u3066\u7528\u3044\u308b\u5834\u5408\u306f\u51fa\u5178\u30fb\u5b9a\u7fa9\u3092\u660e\u793a\u3059\u308b\u3053\u3068\u3002<\/li>\n\n\n\n<li><strong>\u795e\u7d4c\u5e79\u7d30\u80de\uff08NSC\uff09<\/strong><\/li>\n\n\n\n<li>\u795e\u7d4c\u3001\u30b0\u30ea\u30a2\uff08\u30a2\u30b9\u30c8\u30ed\u30b5\u30a4\u30c8\u30fb\u30aa\u30ea\u30b4\u30c7\u30f3\u30c9\u30ed\u30b5\u30a4\u30c8\uff09\u3078\u306e\u5206\u5316\u80fd<\/li>\n\n\n\n<li>\u810a\u9ac4\u640d\u50b7\u3001\u30d1\u30fc\u30ad\u30f3\u30bd\u30f3\u75c5\u3001ALS\u6cbb\u7642\u3078\u306e\u81e8\u5e8a\u5fdc\u7528\u7814\u7a76<\/li>\n\n\n\n<li><strong>\u305d\u306e\u4ed6\u306e\u7d44\u7e54\u5e79\u7d30\u80de<\/strong><\/li>\n\n\n\n<li>\u76ae\u819a\u30fb\u6bdb\u5305\u5e79\u7d30\u80de\uff08\u30d0\u30eb\u30b8\u9818\u57df\uff09\uff1a\u71b1\u50b7\u30fb\u7622\u75d5\u6cbb\u7642<\/li>\n\n\n\n<li>\u8178\u7ba1\u5e79\u7d30\u80de\uff08Lgr5\u967d\u6027\uff09\uff1a\u8178\u7ba1\u30aa\u30eb\u30ac\u30ce\u30a4\u30c9\u7814\u7a76\u306e\u57fa\u76e4<\/li>\n\n\n\n<li>\u5fc3\u7b4b\u524d\u99c6\u7d30\u80de\uff1a\u5fc3\u7b4b\u518d\u751f\u7814\u7a76\uff08\u81e8\u5e8a\u7684\u6709\u7528\u6027\u306f\u672a\u78ba\u7acb\uff09<\/li>\n\n\n\n<li>\u809d\u524d\u99c6\u7d30\u80de\uff1a\u809d\u4e0d\u5168\u30fb\u809d\u786c\u5909\u6cbb\u7642\u3078\u306e\u5fdc\u7528\u7814\u7a76<\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Lu W, Allickson J. Mesenchymal stromal cell therapy: Progress to date and future outlook. <em>Mol Ther<\/em>. 2025;33(6):2679-2688. DOI: 10.1016\/j.ymthe.2025.02.003. URL: <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/39916329\/\">https:\/\/pubmed.ncbi.nlm.nih.gov\/39916329\/<\/a><\/li>\n\n\n\n<li>Shan Y, et al. Pharmacokinetic characteristics of mesenchymal stem cells in translational challenges. <em>Signal Transduct Target Ther<\/em>. 2024. DOI: 10.1038\/s41392-024-01936-8.<\/li>\n\n\n\n<li>Dominici M, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. <em>Cytotherapy<\/em>. 2006;8(4):315-317.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c5\u7ae0\u3000\u7d44\u7e54\u5de5\u5b66\u30fb\u30d0\u30a4\u30aa\u30de\u30c6\u30ea\u30a2\u30eb\u2015\u2015\u8db3\u5834\u30fb\u5897\u6b96\u56e0\u5b50\u30fb\u30d0\u30a4\u30aa\u30ea\u30a2\u30af\u30bf\u30fc<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>\u7d44\u7e54\u5de5\u5b66\u306e3\u8981\u7d20\uff08\u7d30\u80de\uff0b\u8db3\u5834\uff0b\u30b7\u30b0\u30ca\u30eb\u5206\u5b50\uff09\u3001\u5929\u7136\u30fb\u5408\u6210\u30d0\u30a4\u30aa\u30de\u30c6\u30ea\u30a2\u30eb\u3001\u30cf\u30a4\u30c9\u30ed\u30b2\u30eb\u3001\u30d0\u30a4\u30aa\u30bb\u30e9\u30df\u30c3\u30af\u30b9\u3001\u5897\u6b96\u56e0\u5b50\u3068\u305d\u306e\u5f90\u653e\u6280\u8853\u3001\u30d0\u30a4\u30aa\u30ea\u30a2\u30af\u30bf\u30fc\u8a2d\u8a08\u3002\u81e8\u5e8a\u533b\u306b\u5fc5\u8981\u306a\u6750\u6599\u9078\u629e\u306e\u5224\u65ad\u57fa\u6e96\u306b\u7126\u70b9\u3092\u5f53\u3066\u308b\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u7d44\u7e54\u5de5\u5b66\u306e3\u8981\u7d20<\/strong><\/li>\n\n\n\n<li>\u7d30\u80de\uff08\u5e79\u7d30\u80de\u3001\u524d\u99c6\u7d30\u80de\u3001\u5206\u5316\u7d30\u80de\uff09<\/li>\n\n\n\n<li>\u8db3\u5834\uff08\u30b9\u30ad\u30e3\u30d5\u30a9\u30fc\u30eb\u30c9\uff09\uff1a\u7d30\u80de\u306e\u4e09\u6b21\u5143\u652f\u6301\u69cb\u9020<\/li>\n\n\n\n<li>\u30b7\u30b0\u30ca\u30eb\u5206\u5b50\uff1a\u5897\u6b96\u56e0\u5b50\u3001\u30b5\u30a4\u30c8\u30ab\u30a4\u30f3\u3001\u7269\u7406\u7684\u523a\u6fc0<\/li>\n\n\n\n<li><strong>\u5929\u7136\u30d0\u30a4\u30aa\u30de\u30c6\u30ea\u30a2\u30eb<\/strong><\/li>\n\n\n\n<li>\u30b3\u30e9\u30fc\u30b2\u30f3\uff08I\u578b\u3001II\u578b\uff09\uff1a\u9aa8\u30fb\u8edf\u9aa8\u30fb\u8171\u3078\u306e\u5fdc\u7528<\/li>\n\n\n\n<li>\u30bc\u30e9\u30c1\u30f3\uff08\u5909\u6027\u30b3\u30e9\u30fc\u30b2\u30f3\uff09\uff1aGelMA\u3078\u306e\u8a98\u5c0e\u4f53\u5316<\/li>\n\n\n\n<li>\u30d2\u30a2\u30eb\u30ed\u30f3\u9178\uff1a\u95a2\u7bc0\u30fb\u76ae\u819a\u30fb\u773c\u79d1\u3078\u306e\u5fdc\u7528<\/li>\n\n\n\n<li>\u30d5\u30a3\u30d6\u30ea\u30f3\uff1aPRP\u7642\u6cd5\u306e\u4e3b\u6210\u5206\u3001\u6025\u901f\u306a\u30b2\u30eb\u5316<\/li>\n\n\n\n<li>\u8131\u7d30\u80de\u5316\u7d30\u80de\u5916\u57fa\u8cea\uff08dECM\uff09\uff1a\u81d3\u5668\u56fa\u6709\u306e\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u6210\u5206\u3092\u4fdd\u6301<\/li>\n\n\n\n<li><strong>\u5408\u6210\u30d0\u30a4\u30aa\u30de\u30c6\u30ea\u30a2\u30eb<\/strong><\/li>\n\n\n\n<li>PLA\uff08\u30dd\u30ea\u4e73\u9178\uff09\u3001PGA\uff08\u30dd\u30ea\u30b0\u30ea\u30b3\u30fc\u30eb\u9178\uff09\u3001PLGA\uff08\u5171\u91cd\u5408\u4f53\uff09\uff1a\u751f\u5206\u89e3\u6027\u3001\u5206\u89e3\u901f\u5ea6\u306e\u5236\u5fa1\u53ef\u80fd<\/li>\n\n\n\n<li>PEG\uff08\u30dd\u30ea\u30a8\u30c1\u30ec\u30f3\u30b0\u30ea\u30b3\u30fc\u30eb\uff09\uff1a\u30bf\u30f3\u30d1\u30af\u5438\u7740\u6291\u5236\u3001\u7d30\u80de\u63a5\u7740\u6027\u306e\u4ed8\u4e0e<\/li>\n\n\n\n<li>GelMA\uff08\u30bc\u30e9\u30c1\u30f3\u30e1\u30bf\u30af\u30ea\u30ec\u30fc\u30c8\uff09\uff1a\u5149\u67b6\u6a4b\u306b\u3088\u308b\u5f62\u72b6\u81ea\u7531\u5ea6<\/li>\n\n\n\n<li><strong>\u5897\u6b96\u56e0\u5b50\u3068\u5f90\u653e\u6280\u8853<\/strong><\/li>\n\n\n\n<li>BMP-2\uff08\u9aa8\u5f62\u6210\u30bf\u30f3\u30d1\u30af\u8cea-2\uff09\uff1a\u9aa8\u518d\u751f<\/li>\n\n\n\n<li>TGF-\u03b2\uff1a\u8edf\u9aa8\u30fb\u7e4a\u7dad\u6027\u7d44\u7e54\u306e\u518d\u751f<\/li>\n\n\n\n<li>VEGF\uff08\u8840\u7ba1\u5185\u76ae\u5897\u6b96\u56e0\u5b50\uff09\uff1a\u8840\u7ba1\u65b0\u751f<\/li>\n\n\n\n<li>FGF\uff08\u7dda\u7dad\u82bd\u7d30\u80de\u5897\u6b96\u56e0\u5b50\uff09\uff1a\u591a\u69d8\u306a\u7d44\u7e54\u4fee\u5fa9<\/li>\n\n\n\n<li>\u5f90\u653e\u6280\u8853\uff1a\u30ca\u30ce\u7c92\u5b50\u5c01\u5165\u3001\u30cf\u30a4\u30c9\u30ed\u30b2\u30eb\u5236\u5fa1\u653e\u51fa\u3001\u30de\u30a4\u30af\u30ed\u30b9\u30d5\u30a7\u30a2<\/li>\n\n\n\n<li><strong>\u30d0\u30a4\u30aa\u30ea\u30a2\u30af\u30bf\u30fc<\/strong><\/li>\n\n\n\n<li>\u704c\u6d41\u578b\uff1a\u5747\u4e00\u306a\u6804\u990a\u30fb\u9178\u7d20\u4f9b\u7d66<\/li>\n\n\n\n<li>\u56de\u8ee2\u578b\uff1a\u526a\u65ad\u529b\u306e\u8efd\u6e1b<\/li>\n\n\n\n<li>\u4f38\u5c55\u578b\uff1a\u6a5f\u68b0\u7684\u523a\u6fc0\u306b\u3088\u308b\u8171\u30fb\u976d\u5e2f\u306e\u6210\u719f\u5316<\/li>\n\n\n\n<li>\u5927\u898f\u6a21\u57f9\u990a\uff08\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\uff09\u306e\u305f\u3081\u306e\u8a2d\u8a08\u6700\u9069\u5316<\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Langer R, Vacanti JP. Tissue Engineering. <em>Science<\/em>. 1993;260(5110):920-926.<\/li>\n\n\n\n<li><em>Principles of Regenerative Medicine<\/em>, 3rd ed., Part III\uff08\u30d0\u30a4\u30aa\u30de\u30c6\u30ea\u30a2\u30eb\u7ae0\u7fa4\uff09.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c6\u7ae0\u3000\u30b2\u30ce\u30e0\u7de8\u96c6\u6280\u8853\u2015\u2015CRISPR-Cas9\u30fb\u5869\u57fa\u7de8\u96c6\u30fb\u30d7\u30e9\u30a4\u30e0\u7de8\u96c6\u306e\u81e8\u5e8a\u5c55\u958b<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>CRISPR-Cas9\u306e\u4f5c\u7528\u6a5f\u5e8f\u3001\u5869\u57fa\u7de8\u96c6\u3001\u30d7\u30e9\u30a4\u30e0\u7de8\u96c6\u3001\u9001\u9054\u30b7\u30b9\u30c6\u30e0\u3001\u81e8\u5e8a\u5fdc\u7528\u4e8b\u4f8b\u3001\u30aa\u30d5\u30bf\u30fc\u30b2\u30c3\u30c8\u52b9\u679c\u30fb\u514d\u75ab\u539f\u6027\u30fb\u9577\u671f\u5b89\u5168\u6027\u306e\u8ab2\u984c\u3001\u65e5\u672c\u306e2024\u5e74\u5b89\u78ba\u6cd5\u6539\u6b63\u306b\u3088\u308b\u30b2\u30ce\u30e0\u7de8\u96c6\u6280\u8853\u306e\u898f\u5236\u5bfe\u8c61\u5316\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>CRISPR-Cas9\u30b7\u30b9\u30c6\u30e0<\/strong><\/li>\n\n\n\n<li>sgRNA\uff08\u30b7\u30f3\u30b0\u30eb\u30ac\u30a4\u30c9RNA\uff09\u3068Cas9\u30cc\u30af\u30ec\u30a2\u30fc\u30bc\u306e\u8907\u5408\u4f53<\/li>\n\n\n\n<li>PAM\u914d\u5217\uff08NGG\uff09\u3067\u306e\u4e8c\u672c\u9396DNA\u5207\u65ad<\/li>\n\n\n\n<li>HDR\uff08\u76f8\u540c\u7d44\u63db\u3048\u4fee\u5fa9\uff09\u307e\u305f\u306fNHEJ\uff08\u975e\u76f8\u540c\u672b\u7aef\u7d50\u5408\uff09\u306b\u3088\u308b\u4fee\u5fa9<\/li>\n\n\n\n<li>2020\u5e74\u30ce\u30fc\u30d9\u30eb\u5316\u5b66\u8cde\uff08Jennifer Doudna\u3001Emmanuelle Charpentier\uff09<\/li>\n\n\n\n<li><strong>\u5869\u57fa\u7de8\u96c6\uff08Base Editing\uff09<\/strong><\/li>\n\n\n\n<li>CBE\uff08\u30b7\u30c8\u30b7\u30f3\u5869\u57fa\u7de8\u96c6\uff09\uff1aC\u2192T\u5909\u63db<\/li>\n\n\n\n<li>ABE\uff08\u30a2\u30c7\u30cb\u30f3\u5869\u57fa\u7de8\u96c6\uff09\uff1aA\u2192G\u5909\u63db<\/li>\n\n\n\n<li>\u4e8c\u672c\u9396\u5207\u65ad\u306a\u3057\u306b\u9077\u79fb\u5909\u7570\uff08transition\uff09\u3092\u4fee\u5fa9\u53ef\u80fd<\/li>\n\n\n\n<li>\u9077\u79fb\u5909\u7570\u306f\u65e2\u77e5\u306e\u75be\u60a3\u30a2\u30ec\u30eb\u306e\u7d0430%\u3092\u5360\u3081\u308b\u3068\u306e\u6574\u7406\u304c\u3042\u308b<\/li>\n\n\n\n<li>\u203b\u300c\u7d0430%\u300d\u306f\u7406\u8ad6\u4e0a\u306e\u9069\u7528\u7bc4\u56f2\uff08in principle\uff09\u3067\u3042\u308a\u3001\u81e8\u5e8a\u7684\u306b\u3059\u3079\u3066\u6cbb\u7642\u53ef\u80fd\u3067\u3042\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u306a\u3044<\/li>\n\n\n\n<li><strong>\u30d7\u30e9\u30a4\u30e0\u7de8\u96c6\uff08Prime Editing\uff09<\/strong><\/li>\n\n\n\n<li>PEgRNA\uff08\u30d7\u30e9\u30a4\u30e0\u7de8\u96c6\u30ac\u30a4\u30c9RNA\uff09\u3068RT\uff08\u9006\u8ee2\u5199\u9175\u7d20\uff09\u878d\u5408Cas9\u30cb\u30c3\u30ab\u30fc\u30bc<\/li>\n\n\n\n<li>\u516812\u7a2e\u985e\u306e\u5869\u57fa\u5909\u63db\u3001\u5c0f\u898f\u6a21\u633f\u5165\u30fb\u6b20\u5931\u304c\u53ef\u80fd<\/li>\n\n\n\n<li>\u539f\u7406\u4e0a\u3001ClinVar\u306b\u767b\u9332\u3055\u308c\u305f\u65e2\u77e5\u306e\u75be\u60a3\u95a2\u9023\u5909\u7570\u306e\u6700\u592789%\u3092\u4fee\u6b63\u3057\u5f97\u308b\u3068\u3055\u308c\u308b<\/li>\n\n\n\n<li>\u203b\u300c89%\u300d\u306f\u7406\u8ad6\u4e0a\u306e\u9069\u7528\u7bc4\u56f2\uff08in principle\uff09\u3067\u3042\u308a\u3001\u81e8\u5e8a\u7684\u306b\u3059\u3079\u3066\u6cbb\u7642\u53ef\u80fd\u3067\u3042\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u306a\u3044<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aAnzalone AV, Randolph PB, Davis JR, et al. Search-and-replace genome editing without double-strand breaks or donor DNA. <em>Nature<\/em>. 2019;576:149-157. DOI: 10.1038\/s41586-019-1711-4. URL: <a href=\"https:\/\/www.nature.com\/articles\/s41586-019-1711-4\">https:\/\/www.nature.com\/articles\/s41586-019-1711-4<\/a><\/li>\n\n\n\n<li><strong>\u9001\u9054\u30b7\u30b9\u30c6\u30e0<\/strong><\/li>\n\n\n\n<li>AAV\u30d9\u30af\u30bf\u30fc\uff08\u30a2\u30c7\u30ce\u968f\u4f34\u30a6\u30a4\u30eb\u30b9\uff09\uff1a\u9ad8\u52b9\u7387\u3001\u7279\u5b9a\u81d3\u5668\u6307\u5411\u6027<\/li>\n\n\n\n<li>\u8102\u8cea\u30ca\u30ce\u7c92\u5b50\uff08LNP\uff09\uff1amRNA\u9001\u9054\u306b\u6709\u5229\u3001\u514d\u75ab\u539f\u6027\u4f4e<\/li>\n\n\n\n<li>\u30a8\u30ec\u30af\u30c8\u30ed\u30dd\u30ec\u30fc\u30b7\u30e7\u30f3\uff1a\u4f53\u5916\u7de8\u96c6\uff08ex vivo\uff09\u306b\u6709\u5229<\/li>\n\n\n\n<li><strong>\u81e8\u5e8a\u5fdc\u7528\u4e8b\u4f8b<\/strong><\/li>\n\n\n\n<li><strong>Casgevy<\/strong>\uff08exagamglogene autotemcel\uff09\uff1a\u4e16\u754c\u521d\u306eCRISPR\u6cbb\u7642\u85ac\u3001\u938c\u72b6\u8d64\u8840\u7403\u75c7\/\u03b2-\u30b5\u30e9\u30bb\u30df\u30a2\u30012023\u5e7412\u6708FDA\u627f\u8a8d<\/li>\n\n\n\n<li>Verve Therapeutics\u306ePCSK9\u5869\u57fa\u7de8\u96c6\uff08\u5fc3\u8840\u7ba1\u75be\u60a3\u3001Phase I\u9032\u884c\u4e2d\uff09<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aFDA. FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease. 2023\u5e7412\u67088\u65e5. URL: <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease\">https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease<\/a><\/li>\n\n\n\n<li><strong>\u8ab2\u984c\u3068\u30ea\u30b9\u30af<\/strong><\/li>\n\n\n\n<li>\u30aa\u30d5\u30bf\u30fc\u30b2\u30c3\u30c8\u52b9\u679c\uff1a\u610f\u56f3\u3057\u306a\u3044\u90e8\u4f4d\u3067\u306e\u5207\u65ad\u30fb\u7de8\u96c6<\/li>\n\n\n\n<li>\u514d\u75ab\u539f\u6027\uff1aCas9\u30bf\u30f3\u30d1\u30af\u3078\u306e\u514d\u75ab\u53cd\u5fdc\uff08\u65e2\u5b58\u6297\u4f53\u306e\u554f\u984c\uff09<\/li>\n\n\n\n<li>\u9577\u671f\u5b89\u5168\u6027\uff1a\u751f\u6b96\u7d30\u80de\u7cfb\u5217\u3078\u306e\u6f0f\u51fa\u306e\u53ef\u80fd\u6027\uff08\u7279\u306b\u751f\u6b96\u53ef\u80fd\u5e74\u9f62\u60a3\u8005\uff09<\/li>\n\n\n\n<li>\u5927\u898f\u6a21\u633f\u5165\/\u6b20\u5931\uff08large indel\uff09\u306b\u3088\u308b\u6a5f\u80fd\u55aa\u5931\u30ea\u30b9\u30af<\/li>\n\n\n\n<li><strong>\u65e5\u672c\u306e\u898f\u5236<\/strong><\/li>\n\n\n\n<li>2024\u5e74\u5b89\u78ba\u6cd5\u6539\u6b63\uff08\u4ee4\u548c6\u5e746\u670814\u65e5\u516c\u5e03\u3001\u4ee4\u548c7\u5e745\u670831\u65e5\u65bd\u884c\uff09\u306b\u3088\u308a\u300c\u30b2\u30ce\u30e0\u7de8\u96c6\u6280\u8853\u3092\u5fdc\u7528\u3057\u305f\u6280\u8853\u300d\u304c\u898f\u5236\u5bfe\u8c61\u306b\u8ffd\u52a0<\/li>\n\n\n\n<li>\u51fa\u5178\uff1a\u539a\u751f\u52b4\u50cd\u7701Q&amp;A\uff08\u4ee4\u548c7\u5e745\u670830\u65e5\u4ed8\uff09URL: <a href=\"https:\/\/www.mhlw.go.jp\/content\/10800000\/001498987.pdf\">https:\/\/www.mhlw.go.jp\/content\/10800000\/001498987.pdf<\/a><\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Anzalone AV, et al. Nature. 2019 (\u4e0a\u63b2)<\/li>\n\n\n\n<li>FDA. Casgevy Approval. 2023.<\/li>\n\n\n\n<li>\u539a\u751f\u52b4\u50cd\u7701. \u6539\u6b63\u5b89\u78ba\u6cd5Q&amp;A. 2025\u5e745\u670830\u65e5.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u7b2c\u2161\u90e8\u3000\u65e5\u672c\u306e\u898f\u5236\u30fb\u6cd5\u5236\u5ea6\uff08\u7b2c7\uff5e11\u7ae0\uff09<\/h2>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c7\u7ae0\u3000\u4e8c\u5143\u7684\u898f\u5236\u4f53\u5236\u306e\u5168\u4f53\u50cf\u2015\u2015\u5b89\u78ba\u6cd5\u3068\u85ac\u6a5f\u6cd5\u306e\u95a2\u4fc2\u6027<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>\u518d\u751f\u533b\u7642\u63a8\u9032\u6cd5\u306e\u6210\u7acb\u80cc\u666f\u30012014\u5e7411\u670825\u65e5\u306e\u540c\u6642\u65bd\u884c\u3001\u5b89\u78ba\u6cd5\u3068\u85ac\u6a5f\u6cd5\u306e\u9069\u7528\u7bc4\u56f2\u306e\u6574\u7406\u3001\u898f\u5236\u5bfe\u8c61\u306e\u5883\u754c\u7dda\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u518d\u751f\u533b\u7642\u63a8\u9032\u6cd5\u306e\u6210\u7acb\u80cc\u666f<\/strong><\/li>\n\n\n\n<li>2012\u5e7410\u6708\uff1a\u5c71\u4e2d\u4f38\u5f25\u6559\u6388 \u30ce\u30fc\u30d9\u30eb\u751f\u7406\u5b66\u30fb\u533b\u5b66\u8cde\u53d7\u8cde<\/li>\n\n\n\n<li>2013\u5e744\u670826\u65e5\uff1a\u518d\u751f\u533b\u7642\u3092\u56fd\u6c11\u304c\u8fc5\u901f\u304b\u3064\u5b89\u5168\u306b\u53d7\u3051\u3089\u308c\u308b\u3088\u3046\u306b\u3059\u308b\u305f\u3081\u306e\u65bd\u7b56\u306e\u7dcf\u5408\u7684\u306a\u63a8\u9032\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\uff08\u5e73\u621025\u5e74\u6cd5\u5f8b\u7b2c13\u53f7\uff09\u6210\u7acb\u30fb\u516c\u5e03<\/li>\n\n\n\n<li>\u51fa\u5178\uff1a\u56fd\u7acb\u56fd\u4f1a\u56f3\u66f8\u9928. URL: <a href=\"https:\/\/hourei.ndl.go.jp\/simple\/detail?lawId=0000129358&amp;current=1\">https:\/\/hourei.ndl.go.jp\/simple\/detail?lawId=0000129358&amp;current=1<\/a><\/li>\n\n\n\n<li><strong>\u4e8c\u5143\u7684\u898f\u5236\u4f53\u5236\u306e\u69cb\u9020<\/strong><\/li>\n\n\n\n<li><strong>\u5b89\u78ba\u6cd5\uff08\u518d\u751f\u533b\u7642\u7b49\u5b89\u5168\u6027\u78ba\u4fdd\u6cd5\uff09<\/strong>\uff1a\u533b\u7642\u63d0\u4f9b\u5074\u306e\u898f\u5236\uff08\u81e8\u5e8a\u7814\u7a76\u30fb\u81ea\u7531\u8a3a\u7642\uff09<\/li>\n\n\n\n<li><strong>\u85ac\u6a5f\u6cd5\uff08\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u7b49\u306e\u54c1\u8cea\u3001\u6709\u52b9\u6027\u53ca\u3073\u5b89\u5168\u6027\u306e\u78ba\u4fdd\u7b49\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\uff09<\/strong>\uff1a\u88fd\u54c1\u5074\u306e\u898f\u5236\uff08\u627f\u8a8d\u30fb\u88fd\u9020\u8ca9\u58f2\uff09<\/li>\n\n\n\n<li>\u3053\u306e\u4e8c\u5143\u7684\u898f\u5236\u4f53\u5236\u306f\u65e5\u672c\u56fa\u6709\u3067\u3042\u308a\u3001\u56fd\u969b\u7684\u306b\u3082\u30e6\u30cb\u30fc\u30af\u306a\u5236\u5ea6\u8a2d\u8a08<\/li>\n\n\n\n<li><strong>\u898f\u5236\u5bfe\u8c61\u306e\u5883\u754c\u7dda<\/strong><\/li>\n\n\n\n<li>\u6cbb\u9a13\u4e2d\u306e\u88fd\u54c1\uff1a\u5b89\u78ba\u6cd5\u306e\u5bfe\u8c61\u5916\uff08GCP\u7701\u4ee4\u304c\u9069\u7528\uff09<\/li>\n\n\n\n<li>\u627f\u8a8d\u6e08\u307f\u88fd\u54c1\u306e\u9069\u5fdc\u5185\u4f7f\u7528\uff1a\u5b89\u78ba\u6cd5\u306e\u5bfe\u8c61\u5916<\/li>\n\n\n\n<li>\u5b89\u78ba\u6cd5\u304c\u9069\u7528\u3055\u308c\u308b\u306e\u306f\uff1a\u672a\u627f\u8a8d\u7d30\u80de\u6cbb\u7642\u30fbPRP\u7b49\u306e\u81ea\u7531\u8a3a\u7642\u30fb\u81e8\u5e8a\u7814\u7a76<\/li>\n\n\n\n<li><strong>2014\u5e7411\u670825\u65e5 \u540c\u6642\u65bd\u884c\u306e\u610f\u7fa9<\/strong><\/li>\n\n\n\n<li>\u533b\u5e2b\u4e3b\u5c0e\u306e\u7d30\u80de\u6cbb\u7642\uff08\u5b89\u78ba\u6cd5\uff09\u3068\u88fd\u54c1\u958b\u767a\uff08\u85ac\u6a5f\u6cd5\uff09\u306e\u4e26\u884c\u898f\u5236<\/li>\n\n\n\n<li>\u51fa\u5178\uff1a\u539a\u751f\u52b4\u50cd\u7701. URL: <a href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000150542_00016.html\">https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000150542_00016.html<\/a><\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u518d\u751f\u533b\u7642\u63a8\u9032\u6cd5\uff08\u5e73\u621025\u5e74\u6cd5\u5f8b\u7b2c13\u53f7\uff09. 2013\u5e744\u670826\u65e5\u6210\u7acb.<\/li>\n\n\n\n<li>\u518d\u751f\u533b\u7642\u7b49\u5b89\u5168\u6027\u78ba\u4fdd\u6cd5\uff08\u5e73\u621025\u5e74\u6cd5\u5f8b\u7b2c85\u53f7\uff09. 2013\u5e74\u516c\u5e03\u30012014\u5e7411\u670825\u65e5\u65bd\u884c. URL: https:\/\/laws.e-gov.go.jp\/law\/425AC0000000085<\/li>\n\n\n\n<li>\u539a\u751f\u52b4\u50cd\u7701. \u518d\u751f\u533b\u7642\u7b49\u306b\u3064\u3044\u3066\uff1a\u95a2\u4fc2\u6cd5\u4ee4\u3001\u305d\u306e\u4ed6\u95a2\u4fc2\u901a\u77e5\u7b49. URL: <a href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000150542_00016.html\">https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000150542_00016.html<\/a><\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c8\u7ae0\u3000\u518d\u751f\u533b\u7642\u7b49\u5b89\u5168\u6027\u78ba\u4fdd\u6cd5\u2015\u2015\u30ea\u30b9\u30af\u5206\u985e\u3068\u63d0\u4f9b\u8a08\u753b\u5236\u5ea6<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>\u7b2c\u4e00\u7a2e\u30fb\u7b2c\u4e8c\u7a2e\u30fb\u7b2c\u4e09\u7a2e\u306e\u30ea\u30b9\u30af\u5206\u985e\u3001\u63d0\u4f9b\u8a08\u753b\u306e\u4f5c\u6210\u30fb\u63d0\u51fa\u624b\u7d9a\u304d\u3001\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u7fa9\u52d9\u3001\u7f70\u5247\u898f\u5b9a\u30012017\u5e74\u6642\u70b9\u306e\u7d71\u8a08\u30012024\u5e74\u6539\u6b63\u306e3\u3064\u306e\u67f1\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u30ea\u30b9\u30af\u5206\u985e<\/strong> \u30ea\u30b9\u30af\u5206\u985e \u5bfe\u8c61\u7d30\u80de\u306e\u4f8b \u5be9\u67fb\u6a5f\u95a2 \u624b\u7d9a\u304d \u7b2c\u4e00\u7a2e\uff08\u9ad8\u30ea\u30b9\u30af\uff09 iPS\u7d30\u80de\u3001ES\u7d30\u80de\u3001\u907a\u4f1d\u5b50\u5c0e\u5165\u7d30\u80de\u3001\u540c\u7a2e\u5e79\u7d30\u80de\u3001\u52d5\u7269\u7531\u6765\u7d30\u80de \u7279\u5b9a\u8a8d\u5b9a\u518d\u751f\u533b\u7642\u7b49\u59d4\u54e1\u4f1a \u5be9\u67fb\uff0b\u539a\u751f\u79d1\u5b66\u5be9\u8b70\u4f1a\u5be9\u8b70\uff0b90\u65e5\u9593\u306e\u63d0\u4f9b\u5236\u9650 \u7b2c\u4e8c\u7a2e\uff08\u4e2d\u30ea\u30b9\u30af\uff09 \u57f9\u990a\u81ea\u5df1\u4f53\u6027\u5e79\u7d30\u80de\u7b49 \u7279\u5b9a\u8a8d\u5b9a\u518d\u751f\u533b\u7642\u7b49\u59d4\u54e1\u4f1a \u5be9\u67fb\u5f8c\u306b\u63d0\u4f9b\u53ef\u80fd \u7b2c\u4e09\u7a2e\uff08\u4f4e\u30ea\u30b9\u30af\uff09 PRP\u3001\u6d3b\u6027\u5316\u30ea\u30f3\u30d1\u7403\u7b49 \u8a8d\u5b9a\u518d\u751f\u533b\u7642\u7b49\u59d4\u54e1\u4f1a \u5be9\u67fb\u5f8c\u306b\u63d0\u4f9b\u53ef\u80fd<\/li>\n\n\n\n<li><strong>\u63d0\u4f9b\u8a08\u753b\u306e\u63d0\u51fa\u4ef6\u6570\uff08\u5e73\u621029\u5e74\u30082017\u5e74\u300910\u6708\u672b\u6642\u70b9\uff09<\/strong>\uff08\u51fa\u5178\uff1a\u65e5\u672c\u533b\u5e2b\u4f1a\u89e3\u8aac\uff09<\/li>\n\n\n\n<li>\u7b2c\u4e00\u7a2e\uff1a17\u4ef6<\/li>\n\n\n\n<li>\u7b2c\u4e8c\u7a2e\uff1a176\u4ef6<\/li>\n\n\n\n<li>\u7b2c\u4e09\u7a2e\uff1a3,517\u4ef6\uff08\u7b2c\u4e09\u7a2e\u304c\u5727\u5012\u7684\u591a\u6570\u3067PRP\u30fb\u6b6f\u79d1\u304c\u5927\u534a\uff09<\/li>\n\n\n\n<li>\u51fa\u5178\uff1a\u98db\u7530\u8b77\u90a6\uff08\u9806\u5929\u5802\u5927\u5b66\uff09\/ \u65e5\u672c\u533b\u5e2b\u4f1a. \u533b\u306e\u502b\u7406\u306e\u57fa\u790e\u77e5\u8b58 2018\u5e74\u7248\u3010\u4eba\u3092\u5bfe\u8c61\u3068\u3059\u308b\u7814\u7a76\u3011H-6. URL: <a href=\"https:\/\/www.med.or.jp\/doctor\/rinri\/i_rinri\/h06.html\">https:\/\/www.med.or.jp\/doctor\/rinri\/i_rinri\/h06.html<\/a><\/li>\n\n\n\n<li><strong>\u4ee4\u548c6\u5e74\uff082024\u5e74\uff09\u6539\u6b63\u6cd5\u306e3\u3064\u306e\u67f1<\/strong><\/li>\n\n\n\n<li>\u516c\u5e03\u65e5\uff1a2024\u5e746\u670814\u65e5\uff08\u4ee4\u548c6\u5e74\u6cd5\u5f8b\u7b2c51\u53f7\uff09<\/li>\n\n\n\n<li>\u65bd\u884c\u65e5\uff1a2025\u5e745\u670831\u65e5<\/li>\n\n\n\n<li>\u67f1\u2460\uff1a\u300c\u6838\u9178\u7b49\u3092\u7528\u3044\u308b\u533b\u7642\u6280\u8853\u300d\u3078\u306e\u5bfe\u8c61\u62e1\u5927\n<ul class=\"wp-block-list\">\n<li>in vivo\u907a\u4f1d\u5b50\u6cbb\u7642\u306b\u52a0\u3048\u3066\u30b2\u30ce\u30e0\u7de8\u96c6\u6280\u8853\u3092\u5fdc\u7528\u3057\u305f\u6280\u8853\u304a\u3088\u3073mRNA\u3092\u5229\u7528\u3057\u305f\u6280\u8853\u304c\u542b\u307e\u308c\u308b<\/li>\n\n\n\n<li>\u305f\u3060\u3057\u653f\u4ee4\u30fb\u544a\u793a\u306b\u3088\u308b\u9664\u5916\u898f\u5b9a\u306e\u67a0\u7d44\u307f\u304c\u3042\u308b\u305f\u3081\u904b\u7528\u306e\u8a73\u7d30\u306fQ&amp;A\u306b\u6cbf\u3063\u305f\u7cbe\u5bc6\u5316\u304c\u5fc5\u8981<\/li>\n\n\n\n<li>\u51fa\u5178\uff1a\u539a\u751f\u52b4\u50cd\u7701Q&amp;A\uff08\u4ee4\u548c7\u5e745\u670830\u65e5\u4ed8\uff09URL: <a href=\"https:\/\/www.mhlw.go.jp\/content\/10800000\/001498987.pdf\">https:\/\/www.mhlw.go.jp\/content\/10800000\/001498987.pdf<\/a><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u67f1\u2461\uff1a\u8a8d\u5b9a\u518d\u751f\u533b\u7642\u7b49\u59d4\u54e1\u4f1a\u3078\u306e\u7acb\u5165\u691c\u67fb\u30fb\u6b20\u683c\u4e8b\u7531\u306e\u65b0\u8a2d<\/li>\n\n\n\n<li>\u67f1\u2462\uff1a\u9069\u5fdc\u5916\u4f7f\u7528\u306e\u53d6\u6271\u3044\u898b\u76f4\u3057<\/li>\n\n\n\n<li><strong>\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u7fa9\u52d9\u3068\u7f70\u5247<\/strong><\/li>\n\n\n\n<li>\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\uff08\u6b7b\u4ea1\u30fb\u5f8c\u907a\u75c7\u7b49\uff09\u306f\u539a\u751f\u52b4\u50cd\u5927\u81e3\u3078\u901f\u5831\u30fb\u5b9a\u671f\u5831\u544a\u7fa9\u52d9<\/li>\n\n\n\n<li>\u9055\u53cd\u3057\u305f\u5834\u5408\u306e\u7f70\u5247\u898f\u5b9a\uff08\u884c\u653f\u51e6\u5206\u30fb\u5211\u4e8b\u7f70\uff09<\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u539a\u751f\u52b4\u50cd\u7701. \u518d\u751f\u533b\u7642\u7b49\u306e\u5b89\u5168\u6027\u306e\u78ba\u4fdd\u7b49\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u53ca\u3073\u81e8\u5e8a\u7814\u7a76\u6cd5\u306e\u4e00\u90e8\u3092\u6539\u6b63\u3059\u308b\u6cd5\u5f8b\uff08\u4ee4\u548c6\u5e74\u6cd5\u5f8b\u7b2c51\u53f7\uff09. URL: <a href=\"https:\/\/www.mhlw.go.jp\/content\/001265334.pdf\">https:\/\/www.mhlw.go.jp\/content\/001265334.pdf<\/a><\/li>\n\n\n\n<li>\u539a\u751f\u52b4\u50cd\u7701Q&amp;A\uff08\u4ee4\u548c7\u5e745\u670830\u65e5\u4ed8\uff09. URL: <a href=\"https:\/\/www.mhlw.go.jp\/content\/10800000\/001498987.pdf\">https:\/\/www.mhlw.go.jp\/content\/10800000\/001498987.pdf<\/a><\/li>\n\n\n\n<li>\u65e5\u672c\u533b\u5e2b\u4f1a. \u533b\u306e\u502b\u7406\u306e\u57fa\u790e\u77e5\u8b58 2018\u5e74\u7248 H-6. URL: <a href=\"https:\/\/www.med.or.jp\/doctor\/rinri\/i_rinri\/h06.html\">https:\/\/www.med.or.jp\/doctor\/rinri\/i_rinri\/h06.html<\/a><\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c9\u7ae0\u3000\u85ac\u6a5f\u6cd5\u306b\u304a\u3051\u308b\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u2015\u2015\u6761\u4ef6\u4ed8\u304d\u65e9\u671f\u627f\u8a8d\u5236\u5ea6\u306e\u5b9f\u7e3e\u3068\u6559\u8a13<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u5b9a\u7fa9\u3001\u901a\u5e38\u627f\u8a8d\u3068\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d\u306e2\u7d4c\u8def\u3001\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\u306e\u8981\u4ef6\u3001\u627f\u8a8d\u5236\u5ea6\u306e\u91cd\u8981\u306a\u6559\u8a13\uff08\u6210\u529f\u3068\u5931\u6557\u4e8b\u4f8b\uff09\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u5b9a\u7fa9<\/strong><\/li>\n\n\n\n<li>\u30d2\u30c8\u30fb\u52d5\u7269\u7d30\u80de\u52a0\u5de5\u88fd\u54c1<\/li>\n\n\n\n<li>\u907a\u4f1d\u5b50\u6cbb\u7642\u7528\u88fd\u54c1<\/li>\n\n\n\n<li>\u85ac\u6a5f\u6cd5\u7b2c23\u6761\u306e25\u4ee5\u4e0b\u304c\u6839\u62e0\u898f\u5b9a<\/li>\n\n\n\n<li><strong>2\u3064\u306e\u627f\u8a8d\u7d4c\u8def\u306e\u6bd4\u8f03<\/strong> \u7d4c\u8def \u8981\u4ef6 \u671f\u9650 \u4fdd\u967a\u9069\u7528 \u901a\u5e38\u627f\u8a8d RCT\u306b\u3088\u308b\u6709\u52b9\u6027\u30fb\u5b89\u5168\u6027\u306e\u78ba\u7acb \u306a\u3057 \u627f\u8a8d\u5f8c \u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d \u6709\u52b9\u6027\u306e\u63a8\u5b9a\uff08\u975e\u5747\u8cea\u6027\uff09\uff0b\u5b89\u5168\u6027\u306e\u78ba\u8a8d \u6700\u95777\u5e74 \u627f\u8a8d\u3068\u540c\u6642\uff08\u5373\u6642NHI\uff09<\/li>\n\n\n\n<li><strong>\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\u306e\u8981\u4ef6<\/strong><\/li>\n\n\n\n<li>\u5bfe\u8c61\u75be\u60a3\u306e\u91cd\u7be4\u6027\uff08\u751f\u547d\u306b\u91cd\u5927\u306a\u5f71\u97ff\uff09<\/li>\n\n\n\n<li>\u88fd\u54c1\u306e\u975e\u5747\u8cea\u6027\uff08\u7d30\u80de\u88fd\u54c1\u56fa\u6709\u306e\u7279\u6027\uff09<\/li>\n\n\n\n<li>\u6709\u52b9\u6027\u306e\u300c\u63a8\u5b9a\u300d\uff08\u78ba\u7acb\u3067\u306f\u306a\u3044\uff09<\/li>\n\n\n\n<li>\u5b89\u5168\u6027\u306e\u78ba\u8a8d<\/li>\n\n\n\n<li>\u671f\u9650\u5185\u306b\u78ba\u8a8d\u7684\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u672c\u627f\u8a8d\u7533\u8acb\u304c\u7fa9\u52d9<\/li>\n\n\n\n<li><strong>\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\u5236\u5ea6\u306e\u91cd\u8981\u306a\u6559\u8a13<\/strong> <strong>a. \u30cf\u30fc\u30c8\u30b7\u30fc\u30c8\u00ae\uff08\u30c6\u30eb\u30e2\uff09<\/strong><\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u54c1\u76ee\uff1a\u30d2\u30c8\uff08\u81ea\u5df1\uff09\u9aa8\u683c\u7b4b\u7531\u6765\u7d30\u80de\u30b7\u30fc\u30c8<\/li>\n\n\n\n<li>2015\u5e749\u6708\uff1a\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d\uff08\u4e16\u754c\u521d\u306e\u540c\u5236\u5ea6\u9069\u7528\u54c1\u3001\u5fc3\u4e0d\u5168\u60a3\u80057\u4f8b\u306e\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u304f\uff09<\/li>\n\n\n\n<li>\u627f\u8a8d\u671f\u9593\u4e2d\uff1a\u78ba\u8a8d\u7684\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u305f\u304c\u3001\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u3092\u9054\u6210\u3067\u304d\u305a<\/li>\n\n\n\n<li>2024\u5e747\u6708\uff1a\u85ac\u4e8b\u5be9\u8b70\u4f1a\u3067\u300c\u627f\u8a8d\u3059\u308b\u3053\u3068\u306f\u9069\u5207\u3067\u306f\u306a\u3044\u300d\u3068\u7d50\u8ad6\u2192<strong>\u672c\u627f\u8a8d\u306f\u4e0d\u627f\u8a8d<\/strong>\u3001\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d\u306f\u5931\u52b9<\/li>\n\n\n\n<li>\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\u5236\u5ea6\u306e\u300c\u51fa\u53e3\u300d\uff08\u5931\u6557\u4e8b\u4f8b\uff09\u304c\u521d\u3081\u3066\u6a5f\u80fd\u3057\u305f\u4e8b\u4f8b<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aPMDA\u5be9\u8b70\u7d50\u679c\u5831\u544a\u66f8. URL: <a href=\"https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/review-information\/ctp\/0004.html\">https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/review-information\/ctp\/0004.html<\/a><\/li>\n\n\n\n<li>\u51fa\u5178\uff1a\u539a\u52b4\u7701\u30fb\u85ac\u4e8b\u5be9 \u30cf\u30fc\u30c8\u30b7\u30fc\u30c8\u306f&#8221;\u4e0d\u627f\u8a8d&#8221;\u3068\u7d50\u8ad6. URL: <a href=\"https:\/\/www.mixonline.jp\/tabid55.html?artid=76883\">https:\/\/www.mixonline.jp\/tabid55.html?artid=76883<\/a> <strong>b. \u30b3\u30e9\u30c6\u30b8\u30a7\u30f3\u00ae\uff08\u7530\u8fba\u30d5\u30a1\u30fc\u30de\uff09<\/strong><\/li>\n\n\n\n<li>\u54c1\u76ee\uff1aHGF\u907a\u4f1d\u5b50\u6cbb\u7642\u7528\u88fd\u54c1\uff08\u30d7\u30e9\u30b9\u30df\u30c9DNA\u88fd\u54c1\uff09<\/li>\n\n\n\n<li>2019\u5e74\uff1a\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d\uff08\u91cd\u75c7\u865a\u8840\u80a2\uff09<\/li>\n\n\n\n<li>2024\u5e746\u6708\uff1a\u78ba\u8a8d\u7684\u8a66\u9a13\u306b\u95a2\u9023\u3057\u305f\u627f\u8a8d\u7533\u8acb\u53d6\u308a\u4e0b\u3052\u2192\u627f\u8a8d\u5931\u52b9\u30fb\u8ca9\u58f2\u7d42\u4e86<\/li>\n\n\n\n<li>\u51fa\u5178\uff1a\u7530\u8fba\u30d5\u30a1\u30fc\u30de. 2024\u5e746\u670824\u65e5\u767a\u8868. URL: <a href=\"https:\/\/www.tanabe-pharma.com\/ja\/news\/MTPC240624.html\">https:\/\/www.tanabe-pharma.com\/ja\/news\/MTPC240624.html<\/a> <strong>c. \u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u00ae\uff08\u4f4f\u53cb\u30d5\u30a1\u30fc\u30de\uff09<\/strong><\/li>\n\n\n\n<li>\u54c1\u76ee\uff1aiPS\u7d30\u80de\u7531\u6765\u30c9\u30d1\u30df\u30f3\u795e\u7d4c\u524d\u99c6\u7d30\u80de\uff08\u30d1\u30fc\u30ad\u30f3\u30bd\u30f3\u75c5\uff09<\/li>\n\n\n\n<li>2026\u5e743\u67086\u65e5\uff1a\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d<\/li>\n\n\n\n<li>CiRA\u9ad8\u6a4b\u6df3\u6559\u6388\u306e7\u4f8b\u306e\u81e8\u5e8a\u7814\u7a76\uff082\u5e74\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u30677\u4f8b\u4e2d4\u4f8b\u306bmotor\u6539\u5584\uff09\u306b\u57fa\u3065\u304f<\/li>\n\n\n\n<li>\u4e16\u754c\u521d\u306eiPSC\u7531\u6765\u6cbb\u7642\u88fd\u54c1\u306e\u898f\u5236\u5f53\u5c40\u627f\u8a8d\u3068\u3057\u3066\u5831\u3058\u3089\u308c\u3066\u3044\u308b\uff08\u51fa\u5178\uff1aAABB\u3001Science Portal\u7b49\uff09<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aAABB. Japanese Regulatory Panel Recommends Advancing World&#8217;s First iPSC-Based Therapies. 2026\u5e742\u670824\u65e5. URL: <a href=\"https:\/\/www.aabb.org\/news-resources\/news\/article\/2026\/02\/24\/japanese-regulatory-panel-recommends-advancing-world-s-first-ipsc-based-therapies\">https:\/\/www.aabb.org\/news-resources\/news\/article\/2026\/02\/24\/japanese-regulatory-panel-recommends-advancing-world-s-first-ipsc-based-therapies<\/a> <strong>d. \u30ea\u30cf\u30fc\u30c8\u00ae\uff08Cuorips\u793e\uff09<\/strong><\/li>\n\n\n\n<li>\u54c1\u76ee\uff1aiPS\u7d30\u80de\u7531\u6765\u5fc3\u7b4b\u7d30\u80de\u30b7\u30fc\u30c8\uff08\u865a\u8840\u6027\u5fc3\u7b4b\u75c7\uff09<\/li>\n\n\n\n<li>2026\u5e743\u67086\u65e5\uff1a\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d<\/li>\n\n\n\n<li>\u4e16\u754c\u521d\u306eiPSC\u7531\u6765\u6cbb\u7642\u88fd\u54c1\u627f\u8a8d\uff08\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u3068\u540c\u65e5\uff09<\/li>\n\n\n\n<li>\u51fa\u5178\uff1a\u4f4f\u53cb\u30d5\u30a1\u30fc\u30de\u767a\u8868. URL: <a href=\"https:\/\/www.sumitomo-pharma.co.jp\/news\/20260213.html\">https:\/\/www.sumitomo-pharma.co.jp\/news\/20260213.html<\/a><\/li>\n<\/ul>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u65e5\u672c\u306e\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1 \u627f\u8a8d\u54c1\u76ee\uff082026\u5e743\u6708\u6642\u70b9\u30fb\u4e3b\u8981\u54c1\u76ee\uff09<\/strong><\/li>\n\n\n\n<li>\u30b8\u30a7\u30a4\u30b9\u00ae\uff08J-TEC\uff09\uff1a\u81ea\u5bb6\u57f9\u990a\u8868\u76ae\uff082007\u5e74\u627f\u8a8d\uff09<\/li>\n\n\n\n<li>\u30b8\u30e3\u30c3\u30af\u00ae\uff1a\u81ea\u5bb6\u57f9\u990a\u8edf\u9aa8\uff082012\u5e74\u627f\u8a8d\uff09<\/li>\n\n\n\n<li>\u30ad\u30e0\u30ea\u30a2\u00ae\u3001\u30a4\u30a8\u30b9\u30ab\u30eb\u30bf\u00ae\u3001\u30d6\u30ec\u30e4\u30f3\u30b8\u00ae\u3001\u30a2\u30d9\u30af\u30de\u00ae\u3001\u30ab\u30fc\u30d3\u30af\u30c6\u30a3\u00ae\uff1aCAR-T\u88fd\u54c1<\/li>\n\n\n\n<li>\u30c6\u30e0\u30bb\u30eb\u00ae\uff1a\u540c\u7a2eMSC\uff08GVHD\uff09<\/li>\n\n\n\n<li>\u30b9\u30c6\u30df\u30e9\u30c3\u30af\u00ae\uff1a\u81ea\u5bb6\u9aa8\u9ac4MSC\uff08\u810a\u9ac4\u640d\u50b7\uff09\u3010\u6761\u4ef6\u4ed8\u304d\u3011<\/li>\n\n\n\n<li>\u30a2\u30af\u30fc\u30b4\u00ae\uff08SanBio\uff09\uff1a\u540c\u7a2e\u4fee\u98feMSC\uff08\u5916\u50b7\u6027\u8133\u640d\u50b7\uff09\u3010\u6761\u4ef6\u4ed8\u304d\u30012024\u5e747\u6708\u3011<\/li>\n\n\n\n<li>\u30cd\u30d4\u30c3\u30af\u00ae\u3001\u30aa\u30ad\u30e5\u30e9\u30eb\u00ae\u3001\u30b5\u30af\u30e9\u30b7\u30fc\u00ae\u3001\u30d3\u30ba\u30ce\u30d0\u00ae\uff1a\u89d2\u819c\u95a2\u9023\u88fd\u54c1<\/li>\n\n\n\n<li>\u30be\u30eb\u30b2\u30f3\u30b9\u30de\u00ae\uff1aSMA\u907a\u4f1d\u5b50\u6cbb\u7642<\/li>\n\n\n\n<li>\u30eb\u30af\u30b9\u30bf\u30fc\u30ca\u00ae\uff1aRPE65\u907a\u4f1d\u5b50\u6cbb\u7642<\/li>\n\n\n\n<li>\u30d0\u30a4\u30b8\u30e5\u30d9\u30c3\u30af\u00ae\uff1a\u6804\u990a\u969c\u5bb3\u578b\u8868\u76ae\u6c34\u75b1\u75c7 \u907a\u4f1d\u5b50\u6cbb\u7642<\/li>\n\n\n\n<li>\u30b8\u30e3\u30b9\u30df\u30f3\u00ae\uff1a\u5c0b\u5e38\u6027\u767d\u6591<\/li>\n\n\n\n<li>\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u00ae\u3001\u30ea\u30cf\u30fc\u30c8\u00ae\uff1aiPS\u7d30\u80de\u7531\u6765\u88fd\u54c1\uff082026\u5e743\u67086\u65e5\u627f\u8a8d\uff09<\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>PMDA. \u65b0\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u627f\u8a8d\u54c1\u76ee\u4e00\u89a7. URL: <a href=\"https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/review-information\/ctp\/0004.html\">https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/review-information\/ctp\/0004.html<\/a><\/li>\n\n\n\n<li>AABB. 2026\u5e742\u670824\u65e5\u8a18\u4e8b (\u4e0a\u63b2)<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c10\u7ae0\u3000GCTP\u57fa\u6e96\u3068\u7d30\u80de\u52a0\u5de5\u65bd\u8a2d\uff08CPC\uff09\u306e\u7ba1\u7406\u904b\u55b6<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>GCTP\u306e\u6982\u8981\uff08\u7701\u4ee4\u7b2c93\u53f7\u30012014\u5e74\uff09\u3001GMP\u3068\u306e\u4e3b\u8981\u306a\u76f8\u9055\u70b9\u3001CPC\u898f\u5236\u306e\u4e09\u985e\u578b\u3001\u5404\u65bd\u8a2d\u306e\u5c4a\u51fa\u30fb\u8a31\u53ef\u30fb\u8a8d\u5b9a\u306e\u533a\u5225\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>GCTP\u7701\u4ee4\u306e\u6982\u8981<\/strong><\/li>\n\n\n\n<li>\u6b63\u5f0f\u540d\u79f0\uff1a\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\uff08\u5e73\u621026\u5e74\u539a\u751f\u52b4\u50cd\u7701\u4ee4\u7b2c93\u53f7\uff09<\/li>\n\n\n\n<li>\u516c\u5e03\uff1a2014\u5e748\u67086\u65e5\u3001\u65bd\u884c\uff1a2014\u5e7411\u670825\u65e5<\/li>\n\n\n\n<li>\u51fa\u5178\uff1ae-Gov\u6cd5\u4ee4\u691c\u7d22. URL: <a href=\"https:\/\/laws.e-gov.go.jp\/law\/426M60000100093\">https:\/\/laws.e-gov.go.jp\/law\/426M60000100093<\/a><\/li>\n\n\n\n<li><strong>GCTP\u306e\u4e3b\u8981\u8981\u4ef6<\/strong><\/li>\n\n\n\n<li>\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff08GMP\u3068\u7570\u306a\u308a\u6839\u5e79\u7684\u4f4d\u7f6e\u3065\u3051\uff09<\/li>\n\n\n\n<li>\u7d44\u7e54\u4f53\u5236\uff1a\u88fd\u9020\u90e8\u9580\u30fb\u54c1\u8cea\u90e8\u9580\u306e\u72ec\u7acb<\/li>\n\n\n\n<li>\u6587\u66f8\u4f53\u7cfb\uff08\u624b\u9806\u66f8\u30fb\u8a18\u9332\u66f8\uff09<\/li>\n\n\n\n<li>\u65bd\u8a2d\u30fb\u8a2d\u5099\u57fa\u6e96\uff1a\u6e05\u6d44\u5ea6\u7ba1\u7406\u533a\u57df\u30fb\u7121\u83cc\u64cd\u4f5c\u7b49\u533a\u57df\uff08ISO 14644-1\u6e96\u62e0\uff09<\/li>\n\n\n\n<li>\u88fd\u9020\u7ba1\u7406\u30fb\u54c1\u8cea\u7ba1\u7406\uff08\u5de5\u7a0b\u5185\u7ba1\u7406\u3001\u51fa\u8377\u5224\u5b9a\uff09<\/li>\n\n\n\n<li>\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\/\u30d9\u30ea\u30d5\u30a3\u30b1\u30fc\u30b7\u30e7\u30f3<\/li>\n\n\n\n<li>\u9038\u8131\u7ba1\u7406\u30fb\u5909\u66f4\u7ba1\u7406<\/li>\n\n\n\n<li>\u81ea\u5df1\u70b9\u691c\u30fb\u6559\u80b2\u8a13\u7df4<\/li>\n\n\n\n<li><strong>GMP\u3068\u306e\u4e3b\u8981\u306a\u76f8\u9055\u70b9<\/strong><\/li>\n\n\n\n<li>\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u304c\u5236\u5ea6\u306e\u6839\u5e79\u306b\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u3066\u3044\u308b<\/li>\n\n\n\n<li>\u751f\u304d\u305f\u7d30\u80de\u88fd\u54c1\u3078\u306e\u56fa\u6709\u5bfe\u5fdc\uff08\u5897\u6b96\u30fb\u5206\u5316\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\uff09<\/li>\n\n\n\n<li>\u6700\u7d42\u6ec5\u83cc\u4e0d\u53ef\u306a\u88fd\u54c1\u3078\u306e\u5bfe\u51e6\uff08\u7121\u83cc\u64cd\u4f5c\u6cd5\u306e\u53b3\u683c\u5316\uff09<\/li>\n\n\n\n<li><strong>CPC\uff08\u7d30\u80de\u52a0\u5de5\u65bd\u8a2d\uff09\u306e\u898f\u5236\u4e09\u985e\u578b<\/strong>\uff08\u51fa\u5178\uff1a\u65e5\u672c\u533b\u5e2b\u4f1a\u89e3\u8aac\u3001\u5e73\u621029\u5e7410\u6708\u672b\u6642\u70b9\uff09 \u985e\u578b \u5c4a\u51fa\u30fb\u8a31\u53ef \u4ef6\u6570\uff082017\u5e7410\u6708\u672b\u6642\u70b9\uff09 \u9662\u5185\u65bd\u8a2d \u5c4a\u51fa\u5236 2,478\u65bd\u8a2d\u4ee5\u4e0a \u9662\u5916\u65bd\u8a2d \u8a31\u53ef\u5236 58\u65bd\u8a2d\u4ee5\u4e0a \u6d77\u5916\u65bd\u8a2d \u8a8d\u5b9a\u5236 6\u65bd\u8a2d \u51fa\u5178\uff1a\u65e5\u672c\u533b\u5e2b\u4f1a. URL: <a href=\"https:\/\/www.med.or.jp\/doctor\/rinri\/i_rinri\/h06.html\">https:\/\/www.med.or.jp\/doctor\/rinri\/i_rinri\/h06.html<\/a><\/li>\n\n\n\n<li><strong>\u4ee3\u8868\u7684\u306a\u30a2\u30ab\u30c7\u30df\u30a2CPC<\/strong><\/li>\n\n\n\n<li>\u6176\u61c9KHCPC\uff08\u6176\u61c9\u7fa9\u587e\u5927\u5b66\u75c5\u9662 \u7d30\u80de\u57f9\u990a\u52a0\u5de5\u65bd\u8a2d\uff09<\/li>\n\n\n\n<li>\u5927\u962a\u5927\u5b66MTR CPC<\/li>\n\n\n\n<li>\u6771\u5317\u5927\u5b66CPC<\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>GCTP\u7701\u4ee4\uff08\u5e73\u621026\u5e74\u539a\u751f\u52b4\u50cd\u7701\u4ee4\u7b2c93\u53f7\uff09. URL: <a href=\"https:\/\/laws.e-gov.go.jp\/law\/426M60000100093\">https:\/\/laws.e-gov.go.jp\/law\/426M60000100093<\/a><\/li>\n\n\n\n<li>\u65e5\u672c\u533b\u5e2b\u4f1a. \u533b\u306e\u502b\u7406\u306e\u57fa\u790e\u77e5\u8b58 2018\u5e74\u7248 H-6. URL: <a href=\"https:\/\/www.med.or.jp\/doctor\/rinri\/i_rinri\/h06.html\">https:\/\/www.med.or.jp\/doctor\/rinri\/i_rinri\/h06.html<\/a><\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c11\u7ae0\u3000\u518d\u751f\u533b\u7642\u306e\u54c1\u8cea\u4fdd\u8a3c\u2015\u2015\u539f\u6750\u6599\u7ba1\u7406\u304b\u3089\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u307e\u3067<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>\u539f\u6750\u6599\u7ba1\u7406\u3001\u30c9\u30ca\u30fc\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3001\u88fd\u9020\u5de5\u7a0b\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u5de5\u7a0b\u5185\u7ba1\u7406\u3001\u5404\u7a2e\u8a66\u9a13\u3001\u51fa\u8377\u5224\u5b9a\u3001\u51cd\u7d50\u4fdd\u7ba1\u30fb\u8f38\u9001\u6280\u8853\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30b7\u30b9\u30c6\u30e0\u3001\u9038\u8131\u30fb\u5909\u66f4\u7ba1\u7406\u3001CAPA\u3001QbD\u30a2\u30d7\u30ed\u30fc\u30c1\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u539f\u6750\u6599\u7ba1\u7406<\/strong><\/li>\n\n\n\n<li>\u540c\u7a2e\u4f53\u6027\u5e79\u7d30\u80de\u539f\u6599\u4f9b\u7d66\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\uff082024\u5e74\uff09<\/li>\n\n\n\n<li>\u30c9\u30ca\u30fc\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\uff1a\u611f\u67d3\u75c7\u691c\u67fb\uff08HIV\u3001HBV\u3001HCV\u3001HTLV\u7b49\uff09\u3001\u907a\u4f1d\u7684\u30ea\u30b9\u30af\u8a55\u4fa1<\/li>\n\n\n\n<li>\u539f\u6750\u6599\u306e\u898f\u683c\u8a2d\u5b9a\u3068\u9069\u5408\u6027\u8a66\u9a13<\/li>\n\n\n\n<li><strong>\u88fd\u9020\u5de5\u7a0b\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/strong><\/li>\n\n\n\n<li>\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08PV\uff09\uff1a\u88fd\u9020\u5de5\u7a0b\u306e\u518d\u73fe\u6027\u78ba\u8a8d<\/li>\n\n\n\n<li>\u6d17\u6d44\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff1a\u4ea4\u5dee\u6c5a\u67d3\u9632\u6b62<\/li>\n\n\n\n<li>\u74b0\u5883\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\uff1a\u6e05\u6d44\u5ea6\u306e\u7d99\u7d9a\u7684\u78ba\u8a8d<\/li>\n\n\n\n<li><strong>\u54c1\u8cea\u8a66\u9a13<\/strong><\/li>\n\n\n\n<li>\u7121\u83cc\u8a66\u9a13\uff08\u76f4\u63a5\u6cd5\u30fb\u30e1\u30f3\u30d6\u30e9\u30f3\u30d5\u30a3\u30eb\u30bf\u30fc\u6cd5\uff09<\/li>\n\n\n\n<li>\u30de\u30a4\u30b3\u30d7\u30e9\u30ba\u30de\u8a66\u9a13<\/li>\n\n\n\n<li>\u30a8\u30f3\u30c9\u30c8\u30ad\u30b7\u30f3\u8a66\u9a13\uff08LAL\u6cd5\uff09<\/li>\n\n\n\n<li>\u7d30\u80de\u6570\u30fb\u751f\u5b58\u7387\u6e2c\u5b9a<\/li>\n\n\n\n<li>\u8868\u9762\u30de\u30fc\u30ab\u30fc\u89e3\u6790\uff08\u30d5\u30ed\u30fc\u30b5\u30a4\u30c8\u30e1\u30c8\u30ea\u30fc\uff09<\/li>\n\n\n\n<li>\u6a5f\u80fd\u8a66\u9a13\uff08\u5206\u5316\u80fd\u3001\u514d\u75ab\u6291\u5236\u80fd\u7b49\uff09<\/li>\n\n\n\n<li><strong>\u51cd\u7d50\u4fdd\u7ba1\u30fb\u8f38\u9001\u6280\u8853<\/strong>\uff08\u51fa\u5178\uff1a2024\u5e744\u6708\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u30012025\u5e743\u6708Q&amp;A\uff09<\/li>\n\n\n\n<li>\u51cd\u7d50\u4fdd\u8b77\u5264\uff08DMSO\u3001\u30b0\u30ea\u30bb\u30ed\u30fc\u30eb\u7b49\uff09\u306e\u9078\u629e<\/li>\n\n\n\n<li>\u51cd\u7d50\u30d7\u30ed\u30b0\u30e9\u30de\u30fc\uff08\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30c9\u30ec\u30fc\u30c8\u30d5\u30ea\u30fc\u30b6\u30fc\uff09<\/li>\n\n\n\n<li>\u6db2\u4f53\u7a92\u7d20\u4fdd\u7ba1\uff08-196\u2103\uff09<\/li>\n\n\n\n<li>\u8f38\u9001\u6642\u306e\u6e29\u5ea6\u7ba1\u7406\u30fb\u30b3\u30fc\u30eb\u30c9\u30c1\u30a7\u30fc\u30f3<\/li>\n\n\n\n<li><strong>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30b7\u30b9\u30c6\u30e0<\/strong><\/li>\n\n\n\n<li>\u30d0\u30fc\u30b3\u30fc\u30c9\u7ba1\u7406\uff08\u30c9\u30ca\u30fcID\u304b\u3089\u6700\u7d42\u6295\u4e0e\u307e\u3067\u4e00\u8cab\u3057\u305f\u8ffd\u8de1\uff09<\/li>\n\n\n\n<li>\u4e8c\u91cd\u78ba\u8a8d\u4f53\u5236\uff08two-person rule\uff09<\/li>\n\n\n\n<li>\u96fb\u5b50\u8a18\u9332\u30fb\u96fb\u5b50\u7f72\u540d\uff08ER\/ES\uff09\u306e\u6d3b\u7528<\/li>\n\n\n\n<li><strong>\u9038\u8131\u7ba1\u7406\u30fb\u5909\u66f4\u7ba1\u7406\u30fbCAPA<\/strong><\/li>\n\n\n\n<li>\u9038\u8131\uff08deviation\uff09\u306e\u5206\u985e\u30fb\u8a55\u4fa1\u30fb\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9<\/li>\n\n\n\n<li>\u5909\u66f4\u7ba1\u7406\uff1a\u8efd\u5fae\u5909\u66f4\u30fb\u4e00\u90e8\u5909\u66f4\u627f\u8a8d\u7533\u8acb\u306e\u533a\u5225<\/li>\n\n\n\n<li>CAPA\uff08\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff09\u306e\u5b9f\u65bd\u3068\u6709\u52b9\u6027\u78ba\u8a8d<\/li>\n\n\n\n<li><strong>QbD\uff08Quality by Design\uff09\u30a2\u30d7\u30ed\u30fc\u30c1<\/strong><\/li>\n\n\n\n<li>\u54c1\u8cea\u76ee\u6a19\u88fd\u54c1\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\uff08QTPP\uff09\u306e\u8a2d\u5b9a<\/li>\n\n\n\n<li>\u91cd\u8981\u54c1\u8cea\u5c5e\u6027\uff08CQA\uff09\u306e\u7279\u5b9a<\/li>\n\n\n\n<li>\u30c7\u30b6\u30a4\u30f3\u30b9\u30da\u30fc\u30b9\u306e\u78ba\u7acb<\/li>\n\n\n\n<li>\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30ea\u30ea\u30fc\u30b9\u30c6\u30b9\u30c8\uff08RTRT\uff09\u3078\u306e\u5c55\u958b<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u7b2c\u2162\u90e8\u3000\u56fd\u969b\u898f\u5236\u3068\u81e8\u5e8a\u958b\u767a\uff08\u7b2c12\uff5e15\u7ae0\uff09<\/h2>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c12\u7ae0\u3000FDA\u898f\u5236\u2015\u2015HCT\/P\u5206\u985e\u304b\u3089RMAT\u6307\u5b9a\u307e\u3067\u3010\u30d5\u30a1\u30af\u30c8\u30c1\u30a7\u30c3\u30af\u4fee\u6b63\u2460\u2461\u9069\u7528\u6e08\u307f\u3011<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>CBER\/OTP\u306e\u7ba1\u8f44\u300121 CFR Part 1271\u306b\u3088\u308bHCT\/P\u898f\u5236\u3001RMAT\u6307\u5b9a\u5236\u5ea6\u3001\u6700\u65b0\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>CBER\/OTP\u306e\u7ba1\u8f44<\/strong><\/li>\n\n\n\n<li>2023\u5e742\u670826\u65e5\uff1aOffice of Therapeutic Products\uff08OTP\uff09\u8a2d\u7acb\uff08\u65e7OTAT\u3092\u518d\u7de8\u30016\u30b5\u30d6\u30aa\u30d5\u30a3\u30b9\u30fb14\u90e8\u9580\u30fb33\u652f\u90e8\u304b\u3089\u306a\u308b\u300c\u30b9\u30fc\u30d1\u30fc\u30aa\u30d5\u30a3\u30b9\u300d\uff09<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aFDA. Establishment of the Office of Therapeutic Products. URL: <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/establishment-office-therapeutic-products\">https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/establishment-office-therapeutic-products<\/a><\/li>\n\n\n\n<li><strong>HCT\/P\u5206\u985e\uff0821 CFR Part 1271\uff09<\/strong><\/li>\n\n\n\n<li>361 HCT\/P\uff1a\u6700\u5c0f\u9650\u64cd\u4f5c\u304b\u3064\u540c\u7a2e\u6a5f\u80fd\u4f7f\u7528\u2192\u533b\u5e2b\u306e\u88c1\u91cf\u3067\u4f7f\u7528\u53ef\u80fd<\/li>\n\n\n\n<li>351 HCT\/P\uff08BLA\u7d4c\u8def\uff09\uff1a\u4e0a\u8a18\u4ee5\u5916\u2192\u751f\u7269\u88fd\u5264\u3068\u3057\u3066\u627f\u8a8d\u7533\u8acb\u304c\u5fc5\u8981<\/li>\n\n\n\n<li>Same Surgical Procedure Exception<\/li>\n\n\n\n<li>4\u8981\u4ef6\uff1a\u6700\u5c0f\u9650\u64cd\u4f5c\u3001\u540c\u7a2e\u6a5f\u80fd\u4f7f\u7528\u3001\u88fd\u9020\u30fb\u914d\u5e03\u304c\u76ee\u7684\u3067\u306a\u3044\u3001\u88dc\u52a9\u7684\u4f5c\u7528\u307e\u305f\u306f\u81ea\u5df1\u7531\u6765<\/li>\n\n\n\n<li><strong>FDA\u627f\u8a8dCGT\u88fd\u54c1\u6570\uff08\u4fee\u6b63\u2460\uff09<\/strong><\/li>\n\n\n\n<li>FDA\uff08CBER\/OTP\uff09\u304c\u516c\u8868\u3059\u308blicensed products\u306e\u4e00\u89a7\u3067\u306f<strong>48\u88fd\u54c1<\/strong>\uff082025\u5e7412\u67089\u65e5\u73fe\u5728\u3001&#8221;Content current as of 12\/09\/2025&#8243;\uff09<\/li>\n\n\n\n<li>\u203b\u300c\u4f55\u3092CGT\u3068\u3057\u3066\u8a08\u6570\u3059\u308b\u304b\uff08\u9069\u5fdc\u8ffd\u52a0\u306e\u6271\u3044\u7b49\uff09\u300d\u306b\u3088\u308a\u6570\u306f\u5909\u52d5\u3059\u308b\u305f\u3081\u3001\u53c2\u7167\u6642\u306f\u4e0a\u8a18\u306e\u5b9a\u7fa9\u3068\u65e5\u4ed8\u3092\u4f75\u8a18\u3059\u308b\u3053\u3068<\/li>\n\n\n\n<li>\u5185\u8a33\uff1aCAR-T 7\u88fd\u54c1\u3001\u5404\u7a2e\u907a\u4f1d\u5b50\u6cbb\u7642\u88fd\u54c1\u306a\u3069<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aFDA. Approved Cellular and Gene Therapy Products. URL: <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/approved-cellular-and-gene-therapy-products\">https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/approved-cellular-and-gene-therapy-products<\/a><\/li>\n\n\n\n<li><strong>RMAT\u6307\u5b9a\uff08\u4fee\u6b63\u2461\uff09<\/strong>\uff08Regenerative Medicine Advanced Therapy\uff09<\/li>\n\n\n\n<li>2016\u5e74\uff1a21st Century Cures Act\u306b\u3088\u308a\u5275\u8a2d<\/li>\n\n\n\n<li>FDA CBER\u304c\u516c\u8868\u3059\u308b\u516c\u5f0f\u30c7\u30fc\u30bf\uff08&#8221;Data as of September 30, 2025&#8243;\uff09\u306b\u57fa\u3065\u304f\u3068\uff1a\n<ul class=\"wp-block-list\">\n<li>\u7533\u8acb\u53d7\u9818\uff1a388\u4ef6<\/li>\n\n\n\n<li>\u8a8d\u5b9a\uff08Granted\uff09\uff1a193\u4ef6<\/li>\n\n\n\n<li>\u62d2\u5426\uff1a165\u4ef6<\/li>\n\n\n\n<li>\u53d6\u4e0b\u3052\uff1a14\u4ef6<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>\u8a8d\u5b9a\u7387\uff1aFY2024\uff0873%\uff09\u30fbFY2025\u3068\u8fd1\u5e74\u6025\u5897<\/li>\n\n\n\n<li>13\u88fd\u54c1\u304cRMAT\u6307\u5b9a\u5f8c\u306b\u6700\u7d42\u7684\u306a\u5e02\u5834\u627f\u8a8d\u306b\u81f3\u3063\u3066\u3044\u308b\uff08FDA\u516c\u5f0f\u30012025\u5e746\u6708\u6642\u70b9\uff09<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aFDA CBER. Cumulative CBER RMAT Designation Requests. URL: <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/cumulative-cber-regenerative-medicine-advanced-therapy-rmat-designation-requests-received-fiscal\">https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/cumulative-cber-regenerative-medicine-advanced-therapy-rmat-designation-requests-received-fiscal<\/a><\/li>\n\n\n\n<li><strong>\u8fc5\u901f\u627f\u8a8d\u30d7\u30ed\u30b0\u30e9\u30e0<\/strong><\/li>\n\n\n\n<li>Breakthrough Therapy\uff08BT\uff09\u6307\u5b9a<\/li>\n\n\n\n<li>Accelerated Approval\uff08\u30b5\u30ed\u30b2\u30fc\u30c8\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306b\u3088\u308b\u65e9\u671f\u627f\u8a8d\uff09<\/li>\n\n\n\n<li>Priority Review\uff08\u5be9\u67fb\u671f\u9593\u77ed\u7e2e\uff09<\/li>\n\n\n\n<li>RMAT\u6307\u5b9a\uff08\u518d\u751f\u533b\u7642\u5c02\u7528\u306e\u5305\u62ec\u7684\u652f\u63f4\uff09<\/li>\n\n\n\n<li><strong>2025\u5e749\u6708\u306e3\u3064\u306e\u91cd\u8981\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9<\/strong><\/li>\n\n\n\n<li>\u8fc5\u901f\u30d7\u30ed\u30b0\u30e9\u30e0\uff08Expedited Programs for Regenerative Medicine Therapies\uff09<\/li>\n\n\n\n<li>\u5c0f\u96c6\u56e3\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3<\/li>\n\n\n\n<li>\u5e02\u8ca9\u5f8c\u30c7\u30fc\u30bf\u53ce\u96c6<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aFDA. Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance. URL: <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/expedited-programs-regenerative-medicine-therapies-serious-conditions-0\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/expedited-programs-regenerative-medicine-therapies-serious-conditions-0<\/a><\/li>\n\n\n\n<li><strong>2026\u5e74\u30ac\u30a4\u30c0\u30f3\u30b9\u30a2\u30b8\u30a7\u30f3\u30c0<\/strong><\/li>\n\n\n\n<li>\u975e\u816b\u760d\u9069\u5fdcCAR-T<\/li>\n\n\n\n<li>\u7570\u7a2e\u79fb\u690d<\/li>\n\n\n\n<li>\u500b\u5225\u5316\u907a\u4f1d\u5b50\u6cbb\u7642<\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA. Approved Cellular and Gene Therapy Products (as of 12\/09\/2025). \u4e0a\u63b2URL.<\/li>\n\n\n\n<li>FDA CBER. RMAT Designation Requests (Data as of 09\/30\/2025). \u4e0a\u63b2URL.<\/li>\n\n\n\n<li>FDA. Establishment of OTP. \u4e0a\u63b2URL.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c13\u7ae0\u3000EMA\/EU\u898f\u5236\u2015\u2015ATMP\u5206\u985e\u3068\u4e2d\u592e\u5be9\u67fb\u624b\u7d9a\u304d\u3010\u30d5\u30a1\u30af\u30c8\u30c1\u30a7\u30c3\u30af\u4fee\u6b63\u2462\u9069\u7528\u6e08\u307f\u3011<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>ATMP\u306e4\u5206\u985e\u3001CAT\u306e\u5f79\u5272\u3001\u4e2d\u592e\u5be9\u67fb\u624b\u7d9a\u304d\u3001PRIME\u6307\u5b9a\u3001Hospital Exemption\u3001EU\u627f\u8a8dATMP\u306e\u73fe\u72b6\u3068\u5e02\u5834\u64a4\u9000\u554f\u984c\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>ATMP\u898f\u5236\u306e\u6cd5\u7684\u57fa\u76e4<\/strong><\/li>\n\n\n\n<li>Regulation (EC) No 1394\/2007\uff082007\u5e7411\u670813\u65e5\uff09<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aEUR-Lex. URL: https:\/\/eur-lex.europa.eu\/eli\/reg\/2007\/1394\/oj\/eng<\/li>\n\n\n\n<li><strong>ATMP\u306e4\u5206\u985e<\/strong><\/li>\n\n\n\n<li>\u907a\u4f1d\u5b50\u6cbb\u7642\u85ac\uff08GTMP\uff09<\/li>\n\n\n\n<li>\u4f53\u7d30\u80de\u6cbb\u7642\u85ac\uff08sCTMP\uff09<\/li>\n\n\n\n<li>\u7d44\u7e54\u5de5\u5b66\u88fd\u54c1\uff08TEP\uff09<\/li>\n\n\n\n<li>\u8907\u5408ATMP<\/li>\n\n\n\n<li><strong>CAT\uff08\u5148\u7aef\u6cbb\u7642\u59d4\u54e1\u4f1a\uff09\u306e\u5f79\u5272<\/strong><\/li>\n\n\n\n<li>EMA\u5185\u306e\u5c02\u9580\u59d4\u54e1\u4f1a<\/li>\n\n\n\n<li>ATMP\u5206\u985e\u306e\u610f\u898b\u63d0\u4f9b<\/li>\n\n\n\n<li>\u627f\u8a8d\u7533\u8acb\u306e\u8a55\u4fa1<\/li>\n\n\n\n<li><strong>EU ATMP\u627f\u8a8d\u7dcf\u6570<\/strong><\/li>\n\n\n\n<li>\u6587\u732e\u96c6\u8a08\uff08Frontiers in Medicine\uff09\u3067\u7d0427\u54c1\u76ee\uff08\u96c6\u8a08\u6642\u70b9\u3092\u660e\u8a18\u3059\u308b\u3053\u3068\uff09<\/li>\n\n\n\n<li>\u203bATMP\u306e&#8221;\u6570&#8221;\u306f\u300c\u96c6\u8a08\u6642\u70b9\u300d\u300c\u5e02\u5834\u64a4\u9000\u30fb\u5931\u52b9\u54c1\u76ee\u3092\u542b\u3081\u308b\u304b\u300d\u300c\u9069\u5fdc\u8ffd\u52a0\u3092\u3069\u3046\u6271\u3046\u304b\u300d\u3067\u5909\u308f\u308a\u5f97\u308b<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aAlaburde et al. Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency. <em>Frontiers in Medicine<\/em>. 2025;12. DOI: 10.3389\/fmed.2025.1623689. URL: https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC12240929\/<\/li>\n\n\n\n<li><strong>EU\u627f\u8a8dCAR-T\u88fd\u54c1\uff08\u4fee\u6b63\u2462\uff09<\/strong><\/li>\n\n\n\n<li>EU\u3067\u306fCAR-T\u88fd\u54c1\u3068\u3057\u3066<strong>6\u54c1\u76ee\u304c\u627f\u8a8d<\/strong>\u3055\u308c\u3066\u304a\u308a\u3001\u9069\u5fdc\uff08indications\uff09\u3092\u88fd\u54c1\u5225\u306b\u8a08\u4e0a\u3059\u308b\u3068<strong>15\u9069\u5fdc<\/strong>\uff082025\u5e744\u6708\u6642\u70b9\uff09\u3068\u6574\u7406\u3055\u308c\u3066\u3044\u308b<\/li>\n\n\n\n<li>\u203b\u300c15\u88fd\u54c1\u300d\u3068\u8868\u8a18\u3059\u308b\u3068\u8aa4\u308a\u3067\u3042\u308a\u3001\u88fd\u54c1\u6570\u3068\u9069\u5fdc\u6570\u306f\u660e\u78ba\u306b\u533a\u5225\u3057\u3066\u8a18\u8f09\u3059\u308b\u3053\u3068<\/li>\n\n\n\n<li><strong>\u8fc5\u901f\u627f\u8a8d\u5236\u5ea6<\/strong><\/li>\n\n\n\n<li>PRIME\u6307\u5b9a\uff1a\u627f\u8a8dATMP\u306e52%\u304c\u53d6\u5f97<\/li>\n\n\n\n<li>Conditional MA\uff1a\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\uff08\u5e74\u6b21\u66f4\u65b0\uff09<\/li>\n\n\n\n<li>Exceptional Circumstances MA\uff1a\u4f8b\u5916\u7684\u72b6\u6cc1\u627f\u8a8d<\/li>\n\n\n\n<li><strong>Hospital Exemption\uff08\u7b2c28\u67612\u9805\uff09<\/strong><\/li>\n\n\n\n<li>\u975e\u5b9a\u578b\u7684\u30fb\u500b\u5225\u60a3\u8005\u5411\u3051\u30fb\u540c\u4e00\u52a0\u76df\u56fd\u5185\u4f7f\u7528\u306e\u514d\u9664<\/li>\n\n\n\n<li>\u52a0\u76df\u56fd\u9593\u3067\u89e3\u91c8\u306b\u5927\u304d\u306a\u3070\u3089\u3064\u304d<\/li>\n\n\n\n<li><strong>EU ATMP\u5546\u696d\u5316\u306e\u8ab2\u984c\u3068\u5e02\u5834\u64a4\u9000<\/strong><\/li>\n\n\n\n<li>EMA\u3067\u627f\u8a8d\u3055\u308c\u305fATMP\u306e\u3046\u3061\u7d0430%\u304c\u5e02\u5834\u304b\u3089\u64a4\u9000\uff08EMA CAT Quarterly Highlights, 2025\u5e7412\u6708\uff09 \u88fd\u54c1\u540d \u64a4\u9000\u5e74 \u4e3b\u56e0 Glybera 2017 \u6cbb\u7642\u5b9f\u7e3e\u308f\u305a\u304b1\u540d\u30fb\u5546\u696d\u7684\u5931\u6557 Zynteglo 2022 \u30c9\u30a4\u30c4\u3067\u306e\u85ac\u4fa1\u4ea4\u6e09\u5931\u6557\uff08\u20ac1.575M\/\u56de\uff09 Zalmoxis 2019 \u78ba\u8a8d\u7684Phase III\u8a66\u9a13\u306e\u4e3b\u8981\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u672a\u9054\u6210 Alofisel\uff08EU\uff09 2024 \u78ba\u8a8d\u7684\u8a66\u9a13ADMIRE-CD II\u306e\u4e3b\u8981\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u672a\u9054\u6210<\/li>\n<\/ol>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u51fa\u5178\uff08Zynteglo\uff09\uff1aEMA EPAR. URL: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/zynteglo<\/li>\n\n\n\n<li>\u51fa\u5178\uff08Alofisel EU\u64a4\u9000\uff09\uff1aEMA. URL: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/alofisel<\/li>\n<\/ul>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u64a4\u9000\u306e\u6839\u672c\u539f\u56e0<\/strong><\/li>\n\n\n\n<li>EMA\u627f\u8a8d\u306fEU\u5168\u57df\u3067\u6709\u52b9\u3060\u304c\u3001\u5404\u56fd\u306eHTA\uff08\u533b\u7642\u6280\u8853\u8a55\u4fa1\uff09\u30fb\u511f\u9084\u4ea4\u6e09\u306f\u500b\u5225<\/li>\n\n\n\n<li>\u52a0\u76df\u56fd\u9593\u306e\u30a2\u30af\u30bb\u30b9\u683c\u5dee\uff1a\u30c9\u30a4\u30c4\u5229\u7528\u53ef\u80fd\u738789% vs. \u4e00\u90e8\u52a0\u76df\u56fd\u3067\u306fATMP\u304c\u4e00\u5ea6\u3082\u4e0a\u5e02\u3055\u308c\u305a<\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Regulation (EC) No 1394\/2007. \u4e0a\u63b2URL.<\/li>\n\n\n\n<li>Alaburde et al. Frontiers in Medicine. 2025 (\u4e0a\u63b2).<\/li>\n\n\n\n<li>EMA. Zynteglo EPAR. URL: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/zynteglo<\/li>\n\n\n\n<li>EMA. Alofisel EPAR. URL: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/alofisel<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c14\u7ae0\u3000\u898f\u5236\u306e\u56fd\u969b\u6bd4\u8f03\u2015\u2015\u65e5\u7c73\u6b27\u4e09\u6975\u306e\u76f8\u9055\u3068\u53ce\u6582<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>\u4e09\u6975\u306e\u5206\u985e\u4f53\u7cfb\u6bd4\u8f03\u3001\u4f4e\u30ea\u30b9\u30af\u4f8b\u5916\u306e\u6271\u3044\u3001\u8fc5\u901f\u627f\u8a8d\u5236\u5ea6\u6bd4\u8f03\u3001\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\u6bd4\u8f03\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u6c34\u6e96\u306e\u5dee\u7570\u3001\u4fdd\u967a\u9069\u7528\u3001ICH\u30cf\u30fc\u30e2\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3\u3001eCTD v4.0\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u4e09\u6975\u306e\u5206\u985e\u4f53\u7cfb\u6bd4\u8f03<\/strong> \u9805\u76ee \u7c73\u56fd\uff08FDA\uff09 EU\uff08EMA\uff09 \u65e5\u672c\uff08PMDA\uff09 \u88fd\u54c1\u5206\u985e HCT\/P\uff08361\/351\uff09 ATMP\uff084\u5206\u985e\uff09 \u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1 \u4f4e\u30ea\u30b9\u30af\u4f8b\u5916 361 HCT\/P Hospital Exemption \u7b2c\u4e09\u7a2e\u518d\u751f\u533b\u7642\u7b49 \u8fc5\u901f\u627f\u8a8d RMAT\u6307\u5b9a PRIME\u6307\u5b9a \u5148\u99c6\u3051\u5be9\u67fb\u6307\u5b9a \u6761\u4ef6\u4ed8\u304d\u627f\u8a8d Accelerated Approval\uff08\u671f\u9650\u306a\u3057\uff09 Conditional MA\uff08\u5e74\u6b21\u66f4\u65b0\uff09 \u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d\uff08\u6700\u95777\u5e74\uff09 \u4fdd\u967a\u9069\u7528 \u5e02\u5834\u5f8c\u4ea4\u6e09 \u56fd\u5225\u4ea4\u6e09 \u627f\u8a8d\u3068\u540c\u6642\u306bNHI\u5373\u6642\u9069\u7528<\/li>\n\n\n\n<li><strong>\u30a8\u30d3\u30c7\u30f3\u30b9\u6c34\u6e96\u306e\u5dee\u7570<\/strong><\/li>\n\n\n\n<li>\u65e5\u672c\u306f\u6b74\u53f2\u7684\u306b\u5c0f\u898f\u6a21\u30c7\u30fc\u30bf\u3067\u306e\u627f\u8a8d\u3042\u308a\uff08\u30cf\u30fc\u30c8\u30b7\u30fc\u30c8\uff1a7\u4f8b\uff09<\/li>\n\n\n\n<li>FDA\uff1a\u7121\u4f5c\u70ba\u5316\u6bd4\u8f03\u8a66\u9a13\uff08RCT\uff09\u304c\u539f\u5247<\/li>\n\n\n\n<li>EU\uff1aConditional MA\/Exceptional Circumstances\u3067\u67d4\u8edf\u5bfe\u5fdc<\/li>\n\n\n\n<li>\u65e5\u672c\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\uff1a\u6709\u52b9\u6027\u306e\u300c\u63a8\u5b9a\u300d\u3067\u3082\u627f\u8a8d\u53ef\u80fd\uff08\u6700\u95777\u5e74\u306e\u78ba\u8a8d\u671f\u9593\u4ed8\u304d\uff09<\/li>\n\n\n\n<li><strong>eCTD v4.0\uff08\u96fb\u5b50\u7533\u8acb\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\uff09<\/strong><\/li>\n\n\n\n<li>\u65e5\u672cPMDA\u306f2022\u5e744\u6708\u306b\u53d7\u4ed8\u958b\u59cb\uff08\u4e16\u754c\u306b\u5148\u884c\uff09<\/li>\n\n\n\n<li>2026\u5e744\u6708\u4ee5\u964d\u306e\u7533\u8acb\u306f\u7fa9\u52d9\u5316\u4e88\u5b9a<\/li>\n\n\n\n<li>\u203b\u300c\u4e16\u754c\u521d\u5c0e\u5165\u300d\u3068\u3059\u308b\u5834\u5408\u306f\u300c\u53d7\u4ed8\u958b\u59cb\u304c\u65e9\u671f\u300d\u300c\u7fa9\u52d9\u5316\u304c\u5148\u884c\u300d\u306e\u610f\u5473\u306b\u9650\u5b9a\u3059\u308b\u3053\u3068\u304c\u9069\u5207<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aPMDA. ICH-M8 eCTD. URL: https:\/\/www.pmda.go.jp\/int-activities\/int-harmony\/ich\/0037.html<\/li>\n\n\n\n<li><strong>ICH\u30cf\u30fc\u30e2\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3<\/strong><\/li>\n\n\n\n<li>ICH Q8\uff08\u88fd\u54c1\u958b\u767a\uff09\u3001Q9\uff08\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff09\u3001Q10\uff08\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\uff09<\/li>\n\n\n\n<li>\u518d\u751f\u533b\u7642\u88fd\u54c1\u306b\u5bfe\u3059\u308bICH Q12\uff08\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff09\u306e\u9069\u7528<\/li>\n<\/ol>\n\n\n\n<p><strong>\u51fa\u5178\u30fb\u5f15\u7528\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>PMDA. ICH-M8 eCTD. URL: https:\/\/www.pmda.go.jp\/int-activities\/int-harmony\/ich\/0037.html<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c15\u7ae0\u3000\u518d\u751f\u533b\u7642\u306e\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3068\u30a8\u30d3\u30c7\u30f3\u30b9\u8a55\u4fa1<\/h3>\n\n\n\n<p><strong>\u7ae0\u306e\u5185\u5bb9\uff1a<\/strong><br>\u518d\u751f\u533b\u7642\u7279\u6709\u306e\u8ab2\u984c\u3001\u9769\u65b0\u7684\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\uff08FDA 2025\u5e749\u6708\u30ac\u30a4\u30c0\u30f3\u30b9\uff09\u3001\u30b5\u30ed\u30b2\u30fc\u30c8\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3001RWE\u306e\u6d3b\u7528\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u30fb\u9577\u671f\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u3002<\/p>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u518d\u751f\u533b\u7642\u7279\u6709\u306e\u8ab2\u984c<\/strong><\/li>\n\n\n\n<li>\u5c0f\u898f\u6a21\u691c\u4f53\uff08\u5e0c\u5c11\u75be\u60a3\u3001\u88fd\u9020\u30b3\u30b9\u30c8\uff09<\/li>\n\n\n\n<li>\u7d30\u80de\u88fd\u54c1\u306e\u975e\u5747\u8cea\u6027\uff08\u30d0\u30c3\u30c1\u9593\u5909\u52d5\u3001\u30c9\u30ca\u30fc\u5909\u52d5\uff09<\/li>\n\n\n\n<li>\u4e0d\u53ef\u9006\u7684\u4ecb\u5165\uff08\u4e00\u5ea6\u6295\u4e0e\u3059\u308b\u3068\u53d6\u308a\u6d88\u305b\u306a\u3044\uff09<\/li>\n\n\n\n<li>\u52d5\u7269\u30e2\u30c7\u30eb\u306e\u9650\u754c\uff08\u514d\u75ab\u4e0d\u5168\u30e2\u30c7\u30eb\u7b49\u306e\u554f\u984c\uff09<\/li>\n\n\n\n<li>\u9577\u671f\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u306e\u5fc5\u8981\u6027\uff08\u9577\u671f\u5b89\u5168\u6027\u306e\u8a55\u4fa1\uff09<\/li>\n\n\n\n<li><strong>\u9769\u65b0\u7684\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\uff08FDA 2025\u5e749\u6708\u30ac\u30a4\u30c0\u30f3\u30b9\u306e6\u624b\u6cd5\uff09<\/strong><\/li>\n\n\n\n<li>\u5358\u7fa4\u8a66\u9a13\uff0b\u81ea\u7136\u6b74\u5bfe\u7167\uff08historical controls\uff09<\/li>\n\n\n\n<li>\u75be\u60a3\u9032\u884c\u30e2\u30c7\u30ea\u30f3\u30b0\uff08disease progression modeling\uff09<\/li>\n\n\n\n<li>\u5916\u90e8\u5bfe\u7167\u7814\u7a76\uff08external control arm\uff09<\/li>\n\n\n\n<li>\u9069\u5fdc\u7684\u30c7\u30b6\u30a4\u30f3\uff08adaptive design\uff09<\/li>\n\n\n\n<li>\u30d9\u30a4\u30ba\u578b\u30c7\u30b6\u30a4\u30f3\uff08Bayesian design\uff09<\/li>\n\n\n\n<li>\u30de\u30b9\u30bf\u30fc\u30d7\u30ed\u30c8\u30b3\u30eb\uff08master protocol\uff1a\u30d0\u30b9\u30b1\u30c3\u30c8\/\u30a2\u30f3\u30d6\u30ec\u30e9\/\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u8a66\u9a13\uff09<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aFDA Draft Guidance. Expedited Programs for Regenerative Medicine Therapies. 2025\u5e749\u6708. URL: https:\/\/www.fda.gov\/media\/188874\/download<\/li>\n\n\n\n<li><strong>\u30b5\u30ed\u30b2\u30fc\u30c8\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8<\/strong><\/li>\n\n\n\n<li>\u907a\u4f1d\u5b50\u6cbb\u7642\u306e\u300c\u30e6\u30cb\u30d0\u30fc\u30b5\u30eb\u30fb\u30d1\u30b9\u30a6\u30a7\u30a4\u300d\uff1a\u907a\u4f1d\u5b50\u8ee2\u5199\u2192\u30bf\u30f3\u30d1\u30af\u5408\u6210\u2192\u6a5f\u80fd\u6d3b\u6027\u2192\u30af\u30ea\u30a2\u30e9\u30f3\u30b9<\/li>\n\n\n\n<li>FDA\u306b\u3088\u308b\u30b5\u30ed\u30b2\u30fc\u30c8\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306e\u5408\u7406\u5316\uff08accelerated approval\u7d4c\u8def\uff09<\/li>\n\n\n\n<li><strong>\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30a8\u30d3\u30c7\u30f3\u30b9\uff08RWE\uff09\u306e\u6d3b\u7528<\/strong><\/li>\n\n\n\n<li>\u5e02\u8ca9\u5f8c\u306e\u9577\u671f\u5b89\u5168\u6027\u30c7\u30fc\u30bf\u306e\u53ce\u96c6<\/li>\n\n\n\n<li>\u5b9f\u81e8\u5e8a\u3067\u306e\u6709\u52b9\u6027\u78ba\u8a8d\uff08\u627f\u8a8d\u5f8c\u306e\u78ba\u8a8d\u7684\u30a8\u30d3\u30c7\u30f3\u30b9\uff09<\/li>\n\n\n\n<li>\u30ec\u30b8\u30b9\u30c8\u30ea\u3068\u306e\u9023\u643a<\/li>\n\n\n\n<li><strong>\u5e02\u8ca9\u5f8c\u8abf\u67fb\u30fb\u9577\u671f\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08LTFU\uff09<\/strong><\/li>\n\n\n\n<li>FDA\u306f\u907a\u4f1d\u5b50\u6cbb\u7642\u306b15\u5e74\u306eLTFU\u3092\u63a8\u5968\uff08\u898b\u76f4\u3057\u691c\u8a0e\u4e2d\uff09<\/li>\n\n\n\n<li>\u65e5\u672c\uff1a\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u8a08\u753b\uff08GPSP\u7701\u4ee4\u306b\u6e96\u62e0\uff09<\/li>\n\n\n\n<li>\u518d\u751f\u533b\u7642\u306b\u304a\u3051\u308b\u5fc3\u81d3\u9818\u57df\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u7d041\/3\u3057\u304b\u7d50\u679c\u3092\u516c\u8868\u3057\u3066\u3044\u306a\u3044\u3068\u3044\u3046\u554f\u984c<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u7b2c\u2163\u90e8\u3000\u8a3a\u7642\u79d1\u5225\u81e8\u5e8a\u5fdc\u7528\uff08\u7b2c16\uff5e23\u7ae0\uff09<\/h2>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c16\u7ae0\u3000\u8840\u6db2\u75be\u60a3\u2015\u2015CAR-T\u7d30\u80de\u7642\u6cd5\u306e\u9032\u5316\u3068\u6b21\u4e16\u4ee3\u514d\u75ab\u7d30\u80de\u6cbb\u7642<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>FDA\u627f\u8a8dCAR-T\u88fd\u54c17\u54c1\u76ee<\/strong><\/li>\n\n\n\n<li>Kymriah\uff08tisagenlecleucel\uff09\uff1aALL\u3001DLBCL<\/li>\n\n\n\n<li>Yescarta\uff08axicabtagene ciloleucel\uff09\uff1aDLBCL\u7b49<\/li>\n\n\n\n<li>Breyanzi\uff08lisocabtagene maraleucel\uff09\uff1aDLBCL\u7b49<\/li>\n\n\n\n<li>Abecma\uff08idecabtagene vicleucel\uff09\uff1a\u591a\u767a\u6027\u9aa8\u9ac4\u816b<\/li>\n\n\n\n<li>Carvykti\uff08ciltacabtagene autoleucel\uff09\uff1a\u591a\u767a\u6027\u9aa8\u9ac4\u816b<\/li>\n\n\n\n<li>Aucatzyl\uff08obecabtagene autoleucel\uff09<\/li>\n\n\n\n<li>Omisirge\uff08omidubicel\uff09<\/li>\n\n\n\n<li>vein-to-vein time\uff1a\u88fd\u9020\u306b3\uff5e6\u9031\u9593<\/li>\n\n\n\n<li><strong>\u65e5\u672c\u627f\u8a8d5\u54c1\u76ee<\/strong>\uff1a\u30ad\u30e0\u30ea\u30a2\u00ae\u3001\u30a4\u30a8\u30b9\u30ab\u30eb\u30bf\u00ae\u3001\u30d6\u30ec\u30e4\u30f3\u30b8\u00ae\u3001\u30a2\u30d9\u30af\u30de\u00ae\u3001\u30ab\u30fc\u30d3\u30af\u30c6\u30a3\u00ae<\/li>\n\n\n\n<li><strong>\u521d\u306eTCR-T\u7642\u6cd5<\/strong>\uff1aTecelra\uff082024\u5e748\u6708FDA\u627f\u8a8d\u3001\u6ed1\u819c\u8089\u816b\uff09<\/li>\n\n\n\n<li><strong>\u6b21\u4e16\u4ee3\u30a2\u30d7\u30ed\u30fc\u30c1<\/strong><\/li>\n\n\n\n<li>\u81ea\u5df1\u514d\u75ab\u75be\u60a3\u3078\u306eCAR-T\uff08SLE\u3001MS\u30011\u578b\u7cd6\u5c3f\u75c5\u7b49\uff09\uff1a2024\u5e74\u5f8c\u534a\u6642\u70b9\u3067CAR-T\u30d1\u30a4\u30d7\u30e9\u30a4\u30f3\u306e51%\u304c\u975e\u816b\u760d\u9069\u5fdc<\/li>\n\n\n\n<li>\u540c\u7a2eCAR-T\uff08CRISPR\u7de8\u96c6\u306b\u3088\u308bHLA\u9664\u53bb\u3001T\u7d30\u80de\u53d7\u5bb9\u4f53\u9664\u53bb\uff09<\/li>\n\n\n\n<li>iPSC\u7531\u6765CAR-T\/CAR-NK\uff08\u30aa\u30d5\u30b6\u30b7\u30a7\u30eb\u30d5\u7d30\u80de\u6cbb\u7642\u306e\u5b9f\u73fe\uff09<\/li>\n\n\n\n<li><strong>MSC\u7642\u6cd5<\/strong><\/li>\n\n\n\n<li><strong>Ryoncil\uff08remestemcel-L\uff09<\/strong>\uff1a2024\u5e7412\u670818\u65e5FDA\u627f\u8a8d\u3001\u521d\u306e\u540c\u7a2e\u30aa\u30d5\u30b6\u30b7\u30a7\u30eb\u30d5\u7d30\u80de\u6cbb\u7642\u304b\u3064\u521d\u306eFDA\u627f\u8a8dMSC\u88fd\u54c1\u3001\u5c0f\u5150SR-aGVHD\uff08\u30b9\u30c6\u30ed\u30a4\u30c9\u62b5\u6297\u6027\u6025\u6027GVHD\uff09\u3001ORR 69.1%<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aFDA. FDA Approves First Mesenchymal Stromal Cell Therapy. 2024\u5e7412\u670818\u65e5. URL: https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host<\/li>\n\n\n\n<li><strong>\u907a\u4f1d\u5b50\u6cbb\u7642<\/strong><\/li>\n\n\n\n<li>Casgevy\uff08\u938c\u72b6\u8d64\u8840\u7403\u75c7\/\u03b2-\u30b5\u30e9\u30bb\u30df\u30a2\u30012023\u5e7412\u6708FDA\u627f\u8a8d\u3001\u7d04220\u4e07\u30c9\u30eb\uff09<\/li>\n\n\n\n<li>Lyfgenia\uff08\u938c\u72b6\u8d64\u8840\u7403\u75c7\u30012023\u5e7412\u6708FDA\u627f\u8a8d\u3001\u7d04310\u4e07\u30c9\u30eb\uff09<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c17\u7ae0\u3000\u5faa\u74b0\u5668\u2015\u2015\u5fc3\u7b4b\u518d\u751f\u306e\u6311\u6226\u3068iPS\u7531\u6765\u5fc3\u7b4b\u30b7\u30fc\u30c8\u306e\u5b9f\u73fe<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>HeartSheet\u306e\u6559\u8a13\uff08\u8a73\u7d30\u306f\u7b2c9\u7ae0\u53c2\u7167\uff09<\/strong><\/li>\n\n\n\n<li>2015\u5e74\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d\u21922024\u5e74\u672c\u627f\u8a8d\u306f\u4e0d\u627f\u8a8d\u30fb\u5931\u52b9<\/li>\n\n\n\n<li>\u9aa8\u683c\u7b4b\u82bd\u7d30\u80de\u30b7\u30fc\u30c8\u306b\u3088\u308b\u5fc3\u6a5f\u80fd\u6539\u5584\u306f\u78ba\u8a8d\u3055\u308c\u306a\u304b\u3063\u305f<\/li>\n\n\n\n<li><strong>\u30ea\u30cf\u30fc\u30c8\u00ae\uff08Cuorips\u793e\uff09<\/strong><\/li>\n\n\n\n<li>\u54c1\u76ee\uff1aiPSC\u7531\u6765\u5fc3\u7b4b\u7d30\u80de\u30b7\u30fc\u30c8\uff08\u865a\u8840\u6027\u5fc3\u7b4b\u75c7\uff09<\/li>\n\n\n\n<li>2026\u5e743\u67086\u65e5\uff1a\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d<\/li>\n\n\n\n<li>8\u4f8b\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u57fa\u3065\u304f<\/li>\n\n\n\n<li>\u4e16\u754c\u521d\u306eiPSC\u7531\u6765\u6cbb\u7642\u88fd\u54c1\u627f\u8a8d\u306e1\u54c1\u76ee<\/li>\n\n\n\n<li><strong>Heartseed HS-001<\/strong><\/li>\n\n\n\n<li>\u54c1\u76ee\uff1aiPSC\u7531\u6765\u5fc3\u7b4b\u7d30\u80de\u30b9\u30d5\u30a7\u30ed\u30a4\u30c9<\/li>\n\n\n\n<li>LAPiS\u8a66\u9a13\uff1a10\u4f8b\u5b8c\u4e86<\/li>\n\n\n\n<li>2025\u5e7412\u6708\uff1a\u6709\u52b9\u6027\u78ba\u8a8d<\/li>\n\n\n\n<li>Novo Nordisk\u3068\u306e\u6700\u59275.98\u5104\u30c9\u30eb\u63d0\u643a\uff082026\u5e74\u672b\u627f\u8a8d\u7533\u8acb\u4e88\u5b9a\uff09<\/li>\n\n\n\n<li><strong>\u305d\u306e\u4ed6\u306e\u30a2\u30d7\u30ed\u30fc\u30c1<\/strong><\/li>\n\n\n\n<li>MSC\u30fbmRNA\u30d9\u30fc\u30b9\u5fc3\u7b4b\u4fee\u5fa9\uff08\u524d\u81e8\u5e8a\u6bb5\u968e\uff09<\/li>\n\n\n\n<li>\u9aa8\u9ac4\u5e79\u7d30\u80de\u51a0\u52d5\u8108\u5185\u6ce8\u5165\uff08TACT\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\uff09<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c18\u7ae0\u3000\u795e\u7d4c\u2015\u2015\u810a\u9ac4\u640d\u50b7\u30fb\u30d1\u30fc\u30ad\u30f3\u30bd\u30f3\u75c5\u30fb\u8133\u5352\u4e2d\u306e\u518d\u751f\u533b\u7642<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u810a\u9ac4\u640d\u50b7<\/strong><\/li>\n\n\n\n<li><strong>\u30b9\u30c6\u30df\u30e9\u30c3\u30af\u00ae<\/strong>\uff08\u30cb\u30d7\u30ed\uff09\uff1a\u81ea\u5bb6\u9aa8\u9ac4MSC\u3001\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d\uff0813\u4f8b\u30d9\u30fc\u30b9\u3001\u79d1\u5b66\u7684\u8a55\u4fa1\u306b\u8b70\u8ad6\u3042\u308a\uff09<\/li>\n\n\n\n<li><strong>\u30b1\u30a4\u30d5\u30a1\u30fc\u30de<\/strong>\uff1aiPSC\u7531\u6765\u795e\u7d4c\u524d\u99c6\u7d30\u80de\u30012025\u5e743\u67084\u4f8b\u306e\u5b89\u5168\u6027\u78ba\u8a8d\uff08\u6176\u61c9\u5927\u5b66\u767a\uff09<\/li>\n\n\n\n<li><strong>\u30d1\u30fc\u30ad\u30f3\u30bd\u30f3\u75c5<\/strong><\/li>\n\n\n\n<li><strong>\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u00ae<\/strong>\uff08\u4f4f\u53cb\u30d5\u30a1\u30fc\u30de\uff09\uff1aiPSC\u7531\u6765\u30c9\u30d1\u30df\u30f3\u795e\u7d4c\u524d\u99c6\u7d30\u80de<\/li>\n\n\n\n<li>2026\u5e743\u67086\u65e5\uff1a\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d<\/li>\n\n\n\n<li>CiRA\u9ad8\u6a4b\u6df3\u6559\u6388\u306e7\u4f8b\u81e8\u5e8a\u7814\u7a76\uff082\u5e74\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u30677\u4f8b\u4e2d4\u4f8b\u306bmotor\u6539\u5584\uff09<\/li>\n\n\n\n<li>\u4e16\u754c\u521d\u306eiPSC\u7531\u6765\u6cbb\u7642\u88fd\u54c1\u627f\u8a8d\u306e1\u54c1\u76ee<\/li>\n\n\n\n<li><strong>\u8133\u5352\u4e2d\/\u5916\u50b7\u6027\u8133\u640d\u50b7\uff08TBI\uff09<\/strong><\/li>\n\n\n\n<li><strong>\u30a2\u30af\u30fc\u30b4\u00ae<\/strong>\uff08SanBio SB623\uff09\uff1a\u540c\u7a2e\u4fee\u98feMSC\uff08\u9aa8\u9ac4\u7531\u6765MSC\u306bNotch1\u907a\u4f1d\u5b50\u5c0e\u5165\uff09<\/li>\n\n\n\n<li>\u9069\u5fdc\uff1a\u5916\u50b7\u6027\u8133\u640d\u50b7\u306b\u3088\u308b\u904b\u52d5\u9ebb\u75fa<\/li>\n\n\n\n<li>2024\u5e747\u6708\uff1a\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d\uff082026\u5e742\u6708\u51fa\u8377\u958b\u59cb\u898b\u8fbc\u307f\uff09<\/li>\n\n\n\n<li><strong>\u7b4b\u840e\u7e2e\u6027\u5074\u7d22\u786c\u5316\u75c7\uff08ALS\uff09<\/strong><\/li>\n\n\n\n<li>NurOwn\u00ae\uff08BrainStorm\uff09\uff1a\u9593\u8449\u7cfb\u5e79\u7d30\u80de\u9ac4\u8154\u5185\u6295\u4e0e\uff08\u81e8\u5e8a\u8a66\u9a13\u6bb5\u968e\uff09<\/li>\n\n\n\n<li>MultiStem\u00ae\uff08Athersys\uff09\uff1aMSC\u9759\u8108\u5185\u6295\u4e0e<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c19\u7ae0\u3000\u773c\u79d1\u2015\u2015\u7db2\u819c\u30fb\u89d2\u819c\u518d\u751f\u3068iPSC\u7531\u6765\u7d30\u80de\u6cbb\u7642\u306e\u5148\u99c6<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>iPS\u7531\u6765RPE\u7d30\u80de\u79fb\u690d\u306e\u6b74\u53f2<\/strong><\/li>\n\n\n\n<li>2014\u5e74\uff1a\u7406\u7814\/\u9ad8\u6a4b\u653f\u4ee3\u535a\u58eb\u3001\u4e16\u754c\u521d\u306eiPSC\u81e8\u5e8a\u7814\u7a76\uff08\u81ea\u5bb6iPSC-RPE\u7d30\u80de\u30b7\u30fc\u30c8\u79fb\u690d\uff09<\/li>\n\n\n\n<li>2017\u5e74\uff1a\u540c\u7a2eiPSC-RPE\uff08\u79fb\u690d\uff09<\/li>\n\n\n\n<li><strong>\u89d2\u819c\u518d\u751f<\/strong><\/li>\n\n\n\n<li>\u5927\u962a\u5927\u5b66 \u897f\u7530\u5e78\u4e8c\u6559\u6388\uff1ahiPSC\u7531\u6765\u89d2\u819c\u4e0a\u76ae\u7d30\u80de\u30b7\u30fc\u30c8\uff084\u4f8b\u4e2d3\u4f8b\u3067\u6539\u5584\u30012025\u5e744\u6708\u306bPMDA\u8a55\u4fa1\u6307\u6a19\u7b56\u5b9a\uff09<\/li>\n\n\n\n<li><strong>Holoclar<\/strong>\uff08EU\uff09\uff1aEU\u521d\u306e\u5e79\u7d30\u80de\u6cbb\u7642\u627f\u8a8d\uff08limbal stem cell deficiency\uff09<\/li>\n\n\n\n<li><strong>\u65e5\u672c\u627f\u8a8d\u54c1\u76ee<\/strong><\/li>\n\n\n\n<li>\u30cd\u30d4\u30c3\u30af\u00ae\uff1a\u89d2\u819c\u4e0a\u76ae\u5e79\u7d30\u80de\u75b2\u5f0a\u75c7<\/li>\n\n\n\n<li>\u30aa\u30ad\u30e5\u30e9\u30eb\u00ae\uff1a\u89d2\u819c\u5185\u76ae\u6a5f\u80fd\u4e0d\u5168<\/li>\n\n\n\n<li>\u30b5\u30af\u30e9\u30b7\u30fc\u00ae\uff1a\u89d2\u819c\u4e0a\u76ae\u5e79\u7d30\u80de\u75b2\u5f0a\u75c7<\/li>\n\n\n\n<li>\u30d3\u30ba\u30ce\u30d0\u00ae\uff1a\u89d2\u819c\u5185\u76ae\u6a5f\u80fd\u4e0d\u5168<\/li>\n\n\n\n<li>\u30cd\u30aa\u30b3\u30fc\u30cd\u30a2\u00ae\uff08J-TEC\uff09\uff1a\u81ea\u5bb6\u57f9\u990a\u89d2\u819c\u4e0a\u76ae<\/li>\n\n\n\n<li><strong>hPSC\u7531\u6765\u773c\u79d1\u88fd\u54c1<\/strong>\uff1a\u5168\u4e16\u754c\u306721\u54c1\u76ee\u304c\u81e8\u5e8a\u8a66\u9a13\u4e2d\uff082024\u5e7412\u6708\u6642\u70b9\uff09<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c20\u7ae0\u3000\u6574\u5f62\u5916\u79d1\u2015\u2015\u8edf\u9aa8\u30fb\u9aa8\u30fb\u976d\u5e2f\u30fb\u8171\u306e\u518d\u751f\u6226\u7565<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u8edf\u9aa8\u518d\u751f<\/strong><\/li>\n\n\n\n<li>\u30b8\u30e3\u30c3\u30af\u00ae\uff08J-TEC\uff09\uff1a\u81ea\u5bb6\u57f9\u990a\u8edf\u9aa8\uff08\u65e5\u672c\u627f\u8a8d\u30012012\u5e74\u21922025\u5e74\u6539\u8a02\uff09<\/li>\n\n\n\n<li>MACI\uff08Vericel\uff09\uff1a\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u8a98\u5c0e\u578bACI\uff08FDA\u627f\u8a8d\uff09<\/li>\n\n\n\n<li>Cartistem\uff1aMSC\u30d9\u30fc\u30b9\uff08\u97d3\u56fd\u627f\u8a8d\uff09<\/li>\n\n\n\n<li><strong>\u9aa8\u518d\u751f<\/strong><\/li>\n\n\n\n<li>BMP-2\uff08INFUSE Bone Graft\uff09\uff1a\u810a\u690e\u56fa\u5b9a\u30fb\u9577\u7ba1\u9aa8\u9aa8\u6298<\/li>\n\n\n\n<li>\u8131\u7070\u9aa8\u57fa\u8cea\uff08DBM\uff09\uff1a\u9aa8\u6b20\u640d\u5145\u586b<\/li>\n\n\n\n<li>3D\u30d7\u30ea\u30f3\u30c8\u8db3\u5834\uff1a\u30c1\u30bf\u30f3\u30fbPEEK\u30fb\u751f\u4f53\u5438\u53ce\u6027\u6750\u6599<\/li>\n\n\n\n<li><strong>\u976d\u5e2f<\/strong><\/li>\n\n\n\n<li>BEAR\u00ae\uff08Bridge-Enhanced ACL Repair\uff09\uff1aFDA\u627f\u8a8d\u3001\u524d\u5341\u5b57\u976d\u5e2f\u4fee\u5fa9\u7528\u30d0\u30a4\u30aa\u30b9\u30ad\u30e3\u30d5\u30a9\u30fc\u30eb\u30c9<\/li>\n\n\n\n<li>\u6ed1\u819cMSC\u306b\u3088\u308bACL\u518d\u5efa\u7814\u7a76<\/li>\n\n\n\n<li><strong>PRP\u7642\u6cd5\u306e\u73fe\u72b6\u3068\u9650\u754c<\/strong><\/li>\n\n\n\n<li>\u5b89\u78ba\u6cd5\u7b2c\u4e09\u7a2e\u306e\u5927\u591a\u6570\u3092\u5360\u3081\u308b<\/li>\n\n\n\n<li>\u30a8\u30d3\u30c7\u30f3\u30b9\u306f\u6df7\u5728\uff08\u5909\u5f62\u6027\u819d\u95a2\u7bc0\u75c7\u3078\u306e\u9069\u5fdc\u3067\u7279\u306b\u8b70\u8ad6\uff09<\/li>\n\n\n\n<li>HSS\uff08Hospital for Special Surgery\uff09\u7b49\u306e\u5927\u898f\u6a21\u7814\u7a76\u304c\u5fc5\u8981<\/li>\n\n\n\n<li><strong>\u534a\u6708\u677f\u30fb\u8171\u677f\u4fee\u5fa9<\/strong>\uff1aMSC\u30fb\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u30a2\u30d7\u30ed\u30fc\u30c1\uff08\u81e8\u5e8a\u8a66\u9a13\u6bb5\u968e\uff09<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c21\u7ae0\u3000\u76ae\u819a\u79d1\u2015\u2015\u57f9\u990a\u8868\u76ae\u304b\u3089\u518d\u751f\u7f8e\u5bb9\u533b\u7642\u307e\u3067<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u30b8\u30a7\u30a4\u30b9\u00ae\uff08J-TEC\uff09<\/strong><\/li>\n\n\n\n<li>\u81ea\u5bb6\u57f9\u990a\u8868\u76ae\u30012007\u5e74\u627f\u8a8d<\/li>\n\n\n\n<li>\u9069\u5fdc\u62e1\u5927\uff1a\u91cd\u75c7\u71b1\u50b7\u2192\u5de8\u5927\u8272\u7d20\u6027\u6bcd\u6591\u2192\u8868\u76ae\u6c34\u75b1\u75c7<\/li>\n\n\n\n<li>\u4fdd\u967a\u511f\u9084\uff1a1\u679a31.4\u4e07\u5186\uff08NHI\u9069\u7528\uff09<\/li>\n\n\n\n<li><strong>\u30b8\u30e3\u30b9\u30df\u30f3\u00ae<\/strong>\uff1a\u5c0b\u5e38\u6027\u767d\u6591\uff08\u81ea\u5bb6\u57f9\u990a\u8868\u76ae\uff09<\/li>\n\n\n\n<li><strong>\u30d0\u30a4\u30b8\u30e5\u30d9\u30c3\u30af\u00ae<\/strong>\uff1a\u907a\u4f1d\u5b50\u6cbb\u7642\uff08COL7A1\u907a\u4f1d\u5b50\u88dc\u6b63\uff09\u3001\u6804\u990a\u969c\u5bb3\u578b\u8868\u76ae\u6c34\u75b1\u75c7\uff082025\u5e74\u627f\u8a8d\uff09<\/li>\n\n\n\n<li><strong>\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u7642\u6cd5<\/strong><\/li>\n\n\n\n<li>\u30de\u30a4\u30af\u30ed\u30cb\u30fc\u30c9\u30ea\u30f3\u30b0\u4f75\u7528\u3001\u6bdb\u9aea\u518d\u751f\u3001\u5275\u50b7\u6cbb\u7652\u3078\u306e\u5fdc\u7528\u304c\u6025\u901f\u306b\u62e1\u5927<\/li>\n\n\n\n<li>\u3057\u304b\u3057FDA\u672a\u627f\u8a8d\u3001\u898f\u5236\u4e0a\u306e\u30b0\u30ec\u30fc\u30be\u30fc\u30f3\uff08ISSCR\u3082\u8b66\u544a\uff09<\/li>\n\n\n\n<li><strong>\u305d\u306e\u4ed6<\/strong><\/li>\n\n\n\n<li>\u81ea\u5bb6\u7dda\u7dad\u82bd\u7d30\u80de\u7642\u6cd5\uff08\u8001\u5316\u30fb\u7622\u75d5\u6cbb\u7642\uff09<\/li>\n\n\n\n<li>\u7d30\u80de\u6fc3\u7e2e\u8102\u80aa\u79fb\u690d\uff08fat grafting with SVF enrichment\uff09<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c22\u7ae0\u3000\u6d88\u5316\u5668\u30fb\u5185\u5206\u6ccc\u30fb\u6ccc\u5c3f\u5668\u2015\u2015\u81b5\u5cf6\u30fb\u809d\u81d3\u30fb\u814e\u81d3\u306e\u518d\u751f<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u81b5\u5cf6\u79fb\u690d\u30681\u578b\u7cd6\u5c3f\u75c5<\/strong><\/li>\n\n\n\n<li>\u30a8\u30c9\u30e2\u30f3\u30c8\u30f3\u30d7\u30ed\u30c8\u30b3\u30eb\uff08Shapiro AM\u30012000\u5e74\uff09\uff1a\u514d\u75ab\u6291\u5236\u306a\u3057\u81b5\u5cf6\u79fb\u690d<\/li>\n\n\n\n<li>iPSC\u7531\u6765\u81b5\u5cf6\u7d30\u80de\uff08TCiRA\/\u6298\u9db4\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\uff09\uff1a\u81e8\u5e8a\u8a66\u9a13\u6bb5\u968e<\/li>\n\n\n\n<li>Viacyte VX-880\uff08Vertex\uff09\uff1a\u30ab\u30d7\u30bb\u30eb\u5316\u81b5\u5cf6\u7d30\u80de\uff08\u81e8\u5e8a\u8a66\u9a13\uff09<\/li>\n\n\n\n<li><strong>\u809d\u81d3<\/strong><\/li>\n\n\n\n<li>\u9aa8\u9ac4\u5e79\u7d30\u80de\u30fb\u809d\u524d\u99c6\u7d30\u80de\u79fb\u690d\uff08\u9aa8\u9ac4\u7d30\u80de\u7d4c\u813e\u52d5\u8108\u6295\u4e0e\u3001\u81e8\u5e8a\u7814\u7a76\uff09<\/li>\n\n\n\n<li>iPSC\u7531\u6765\u809d\u30aa\u30eb\u30ac\u30ce\u30a4\u30c9\u306e3D\u30d0\u30a4\u30aa\u30d7\u30ea\u30f3\u30c6\u30a3\u30f3\u30b0\uff08\u809d\u4e0d\u5168\u30de\u30a6\u30b9\u30e2\u30c7\u30eb\u3067\u6cbb\u7642\u52b9\u679c\u78ba\u8a8d\uff09<\/li>\n\n\n\n<li><strong>\u814e\u81d3<\/strong><\/li>\n\n\n\n<li>\u4eac\u90fd\u5927\u5b66CiRA \u9577\u8239\u7814\u7a76\u5ba4\uff1aiPSC\u7531\u6765\u814e\u524d\u99c6\u7d30\u80de\uff08CKD\u30de\u30a6\u30b9\u30e2\u30c7\u30eb\u3067\u6cbb\u7642\u52b9\u679c\u78ba\u8a8d\u30012025\u5e74\uff09<\/li>\n\n\n\n<li>\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\u8ab2\u984c\uff1a\u60a3\u80051\u4eba\u3042\u305f\u308a\u7d0410\u5104\u7d30\u80de\u304c\u5fc5\u8981<\/li>\n\n\n\n<li>Rege Nephro\uff08CiRA\u767a\u30d9\u30f3\u30c1\u30e3\u30fc\uff09\u306e\u30bf\u30df\u30d0\u30ed\u30c6\u30f3\uff08ADPKD Phase II\u30012024\u5e74\u958b\u59cb\uff09<\/li>\n\n\n\n<li><strong>\u30af\u30ed\u30fc\u30f3\u75c5\uff08\u75d4\u763b\u5408\u4f75\uff09<\/strong><\/li>\n\n\n\n<li>Alofisel\u00ae\uff08darvadstrocel\uff09\uff1a\u8102\u80aa\u7531\u6765\u5e79\u7d30\u80de\u79fb\u690d\uff08\u65e5\u672c\u627f\u8a8d\uff09<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c23\u7ae0\u3000\u6b6f\u79d1\u30fb\u305d\u306e\u4ed6\u2015\u2015\u6b6f\u9ac4\u5e79\u7d30\u80de\u30fb\u8074\u899a\u518d\u751f\u30fb\u65b0\u8208\u9818\u57df<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u6b6f\u9ac4\u5e79\u7d30\u80de\uff08DPSC\uff09<\/strong><\/li>\n\n\n\n<li>\u667a\u6b6f\uff08\u89aa\u77e5\u3089\u305a\uff09\u304b\u3089\u306e\u5bb9\u6613\u306a\u63a1\u53d6<\/li>\n\n\n\n<li>\u4f4e\u514d\u75ab\u539f\u6027\u3001\u591a\u5206\u5316\u80fd\uff08\u9aa8\u82bd\u7d30\u80de\u3001\u8edf\u9aa8\u7d30\u80de\u3001\u795e\u7d4c\u7d30\u80de\u3001\u89d2\u819c\u7d30\u80de\uff09<\/li>\n\n\n\n<li>\u6b6f\u5468\u7d44\u7e54\u518d\u751f\u3078\u306e\u5fdc\u7528<\/li>\n\n\n\n<li><strong>\u816b\u760d\u6eb6\u89e3\u6027\u30a6\u30a4\u30eb\u30b9<\/strong><\/li>\n\n\n\n<li><strong>\u30c7\u30ea\u30bf\u30af\u30c8\u00ae<\/strong>\uff08\u30c6\u30bb\u30eb\u30d1\u30c4\u30ec\u30d6\u3001G47\u0394\u816b\u760d\u6eb6\u89e3\u6027\u30a6\u30a4\u30eb\u30b9\uff09<\/li>\n\n\n\n<li>\u9069\u5fdc\uff1a\u60aa\u6027\u795e\u7d4c\u81a0\u816b\uff08glioblastoma\uff09<\/li>\n\n\n\n<li>2021\u5e74\uff1a\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\uff082028\u5e74\u671f\u9650\uff09<\/li>\n\n\n\n<li><strong>\u96e3\u8074\u6cbb\u7642<\/strong><\/li>\n\n\n\n<li>iPSC\u7531\u6765\u5185\u8033\u7d30\u80de\uff08\u6709\u6bdb\u7d30\u80de\u30fb\u87ba\u65cb\u795e\u7d4c\u7bc0\u7d30\u80de\uff09\u306b\u3088\u308b\u96e3\u8074\u6cbb\u7642\u7814\u7a76\uff08\u524d\u81e8\u5e8a\u6bb5\u968e\uff09<\/li>\n\n\n\n<li><strong>\u7570\u7a2e\u79fb\u690d<\/strong><\/li>\n\n\n\n<li>2025\u5e741\u6708\uff1a\u5b89\u78ba\u6cd5\u4e0b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u7b56\u5b9a<\/li>\n\n\n\n<li>\u30d6\u30bf\u5fc3\u81d3\u79fb\u690d\uff082022\u5e74\u3001Maryland\u5927\u5b66\uff09\u306e\u4e8b\u4f8b\u3068\u4eca\u5f8c\u306e\u8ab2\u984c<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u7b2c\u2164\u90e8\u3000\u502b\u7406\u30fb\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u30fb\u793e\u4f1a\u5b9f\u88c5\uff08\u7b2c24\uff5e27\u7ae0\uff09<\/h2>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c24\u7ae0\u3000\u518d\u751f\u533b\u7642\u306e\u502b\u7406\u7684\u8ab2\u984c\u2015\u2015ES\u7d30\u80de\u304b\u3089\u30b2\u30ce\u30e0\u7de8\u96c6\u307e\u3067<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>ES\u7d30\u80de\u7814\u7a76\u306e\u502b\u7406\u7684\u8ab2\u984c<\/strong><\/li>\n\n\n\n<li>\u30d2\u30c8\u80da\u306e\u9053\u5fb3\u7684\u5730\u4f4d\u3092\u3081\u3050\u308b\u8b70\u8ad6\uff081998\u5e74Thomson\u4ee5\u964d\uff09<\/li>\n\n\n\n<li>\u751f\u547d\u306e\u59cb\u307e\u308a\u306b\u95a2\u3059\u308b\u4fa1\u5024\u89b3\u306e\u591a\u69d8\u6027<\/li>\n\n\n\n<li>\u5ec3\u68c4\u4e88\u5b9a\u80da\u306e\u4f7f\u7528 vs. \u7814\u7a76\u76ee\u7684\u3067\u306e\u80da\u4f5c\u88fd\u306e\u533a\u5225<\/li>\n\n\n\n<li><strong>iPSC\u56fa\u6709\u306e\u502b\u7406\u8ab2\u984c<\/strong><\/li>\n\n\n\n<li>\u30b2\u30ce\u30e0\u60c5\u5831\u306e\u8fd4\u5374\u554f\u984c\uff08\u672a\u77e5\u306e\u907a\u4f1d\u7684\u30ea\u30b9\u30af\u306e\u958b\u793a\uff09<\/li>\n\n\n\n<li>\u4e8c\u6b21\u5229\u7528\uff08\u30d0\u30a4\u30aa\u30d0\u30f3\u30af\u5316\u3001\u4ed6\u306e\u7814\u7a76\u3078\u306e\u8ee2\u7528\uff09<\/li>\n\n\n\n<li>\u304c\u3093\u5909\u7570\u30ea\u30b9\u30af\uff08\u4f53\u7d30\u80de\u5909\u7570\u306e\u84c4\u7a4d\uff09<\/li>\n\n\n\n<li>iPSC\u304b\u3089\u306e\u914d\u5076\u5b50\u8a98\u5c0e\uff08\u751f\u6b96\u502b\u7406\u3078\u306e\u6ce2\u53ca\uff09<\/li>\n\n\n\n<li>\u5e79\u7d30\u80de\u30d9\u30fc\u30b9\u80da\u30e2\u30c7\u30eb\uff08SCBEM\uff09\u306e\u898f\u5236<\/li>\n\n\n\n<li><strong>\u30b2\u30ce\u30e0\u7de8\u96c6\u306e\u502b\u7406\u7684\u533a\u5225<\/strong><\/li>\n\n\n\n<li>\u4f53\u7d30\u80de\u30b2\u30ce\u30e0\u7de8\u96c6\uff1a\u6b21\u4e16\u4ee3\u3078\u907a\u4f1d\u3057\u306a\u3044\uff08\u76f8\u5bfe\u7684\u306b\u8a31\u5bb9\u7bc4\u56f2\uff09<\/li>\n\n\n\n<li>\u751f\u6b96\u7d30\u80de\u7cfb\u5217\u30b2\u30ce\u30e0\u7de8\u96c6\uff1a\u6b21\u4e16\u4ee3\u3078\u306e\u5f71\u97ff\uff08\u73fe\u5728\u306f\u56fd\u969b\u7684\u30b3\u30f3\u30bb\u30f3\u30b5\u30b9\u3067\u7981\u6b62\uff09<\/li>\n\n\n\n<li>He Jiankui\u4e8b\u4ef6\uff082018\u5e74\uff09\u3068\u305d\u306e\u5f8c\u306e\u898f\u5236\u5f37\u5316<\/li>\n\n\n\n<li><strong>ISSCR 2021\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff082025\u5e74SCBEM\u66f4\u65b0\uff09<\/strong><\/li>\n\n\n\n<li>\u30ab\u30c6\u30b4\u30ea\u30fc1A\uff1a\u7279\u5b9a\u306e\u5236\u9650\u5185\u3067\u8a31\u53ef\u3055\u308c\u308b\u7814\u7a76<\/li>\n\n\n\n<li>\u30ab\u30c6\u30b4\u30ea\u30fc1B\uff1a\u5c02\u9580\u59d4\u54e1\u4f1a\u5be9\u67fb\u304c\u5fc5\u8981\u306a\u7814\u7a76<\/li>\n\n\n\n<li>\u30ab\u30c6\u30b4\u30ea\u30fc2\uff1a\u502b\u7406\u5be9\u67fb\u59d4\u54e1\u4f1a\u5be9\u67fb\u304c\u5fc5\u8981\u306a\u7814\u7a76<\/li>\n\n\n\n<li>\u30ab\u30c6\u30b4\u30ea\u30fc3\uff1a\u7981\u6b62\u3055\u308c\u308b\u7814\u7a76<\/li>\n\n\n\n<li>\u51fa\u5178\uff1aISSCR. Guidelines for Stem Cell Research and Clinical Translation (2021). URL: https:\/\/www.isscr.org\/guidelines<\/li>\n\n\n\n<li><strong>\u30a4\u30f3\u30d1\u30af\u30c8\u306e\u4e8c\u9762\u6027<\/strong><\/li>\n\n\n\n<li>\u30cf\u30fc\u30c9\u30fb\u30a4\u30f3\u30d1\u30af\u30c8\uff1a\u6e2c\u5b9a\u53ef\u80fd\u306a\u30ea\u30b9\u30af\uff08\u816b\u760d\u5f62\u6210\u3001\u514d\u75ab\u62d2\u7d76\u3001\u907a\u4f1d\u5b50\u5909\u7570\uff09<\/li>\n\n\n\n<li>\u30bd\u30d5\u30c8\u30fb\u30a4\u30f3\u30d1\u30af\u30c8\uff1a\u884c\u52d5\u30fb\u4fa1\u5024\u89b3\u30fb\u793e\u4f1a\u69cb\u9020\u3078\u306e\u5f71\u97ff\uff08\u683c\u5dee\u306e\u62e1\u5927\u3001\u300c\u5b8c\u74a7\u306a\u5b50\u4f9b\u300d\u3078\u306e\u671f\u5f85\uff09<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c25\u7ae0\u3000\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u3068\u6cbb\u7642\u7684\u8aa4\u89e3\u306e\u514b\u670d<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u6cbb\u7642\u7684\u8aa4\u8a8d\uff08Therapeutic Misconception\uff09<\/strong><\/li>\n\n\n\n<li>\u5b9a\u7fa9\uff1a\u81e8\u5e8a\u8a66\u9a13\u3078\u306e\u53c2\u52a0\u3092\u500b\u5225\u5316\u3055\u308c\u305f\u6cbb\u7642\u3068\u3057\u3066\u8aa4\u8a8d\u3059\u308b\u3053\u3068\uff08Appelbaum PS, 1982\u5e74\uff09<\/li>\n\n\n\n<li>\u30e1\u30c7\u30a3\u30a2\u306e\u80af\u5b9a\u7684\u5831\u9053\u304c\u60a3\u8005\u306e\u671f\u5f85\u3092\u6b6a\u3081\u308b\u554f\u984c<\/li>\n\n\n\n<li>\u6cbb\u7642\u7684\u904e\u5927\u8a55\u4fa1\uff08therapeutic misestimation\uff09\uff1a\u6709\u52b9\u6027\u306e\u904e\u5927\u8a55\u4fa1<\/li>\n\n\n\n<li><strong>\u5e79\u7d30\u80de\u6cbb\u7642\u306eIC\u7279\u6709\u306e\u958b\u793a\u4e8b\u9805<\/strong><\/li>\n\n\n\n<li>\u7d30\u80de\u306e\u7531\u6765\u3068\u51e6\u7406\u65b9\u6cd5\uff08\u81ea\u5bb6 vs. \u540c\u7a2e\uff09<\/li>\n\n\n\n<li>\u5b9f\u9a13\u7684\u6027\u8cea\uff08\u627f\u8a8d\u6e08\u307f\u304b\u5426\u304b\uff09<\/li>\n\n\n\n<li>\u816b\u760d\u5f62\u6210\u30ea\u30b9\u30af\uff08\u7279\u306biPSC\u7531\u6765\u88fd\u54c1\uff09<\/li>\n\n\n\n<li>\u514d\u75ab\u62d2\u7d76\u30ea\u30b9\u30af\uff08\u540c\u7a2e\u7d30\u80de\uff09<\/li>\n\n\n\n<li>\u9577\u671f\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u306e\u5fc5\u8981\u6027<\/li>\n\n\n\n<li>\u8cbb\u7528\u8ca0\u62c5\uff08\u81ea\u7531\u8a3a\u7642\u306e\u5834\u5408\uff09<\/li>\n\n\n\n<li><strong>\u8106\u5f31\u306a\u96c6\u56e3\u3078\u306e\u914d\u616e<\/strong><\/li>\n\n\n\n<li>\u672b\u671f\u60a3\u8005\uff1a\u300c\u6700\u5f8c\u306e\u5e0c\u671b\u300d\u5fc3\u7406\u306b\u3088\u308b\u5224\u65ad\u80fd\u529b\u306e\u4f4e\u4e0b<\/li>\n\n\n\n<li>\u5c0f\u5150\uff1a\u89aa\uff08\u6cd5\u5b9a\u4ee3\u7406\u4eba\uff09\u306b\u3088\u308b\u30a2\u30bb\u30f3\u30c8\u30fb\u30b3\u30f3\u30bb\u30f3\u30c8<\/li>\n\n\n\n<li>\u8a8d\u77e5\u6a5f\u80fd\u969c\u5bb3\u8005\uff1a\u4ee3\u7406\u610f\u601d\u6c7a\u5b9a\u306e\u539f\u5247<\/li>\n\n\n\n<li><strong>\u30c9\u30ca\u30fcIC<\/strong><\/li>\n\n\n\n<li>CiRA iPSC\u30b9\u30c8\u30c3\u30af\u4f9b\u8840\u8005\u304b\u3089\u306eIC<\/li>\n\n\n\n<li>ES\u7d30\u80de\u7528\u80da\u30fb\u914d\u5076\u5b50\u63d0\u4f9b\u8005\u304b\u3089\u306eIC<\/li>\n\n\n\n<li>\u5c06\u6765\u306e\u4e8c\u6b21\u5229\u7528\u3078\u306e\u5305\u62ec\u7684\u540c\u610f<\/li>\n\n\n\n<li><strong>\u52d5\u7684\u540c\u610f\uff08Dynamic Consent\uff09\u30e2\u30c7\u30eb<\/strong><\/li>\n\n\n\n<li>\u7814\u7a76\u306e\u9032\u5c55\u306b\u5fdc\u3058\u3066\u968f\u6642\u540c\u610f\u3092\u66f4\u65b0\u3067\u304d\u308b\u30c7\u30b8\u30bf\u30eb\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0<\/li>\n\n\n\n<li>\u30b2\u30ce\u30e0\u60c5\u5831\u306e\u958b\u793a\u30fb\u8fd4\u5374\u306b\u95a2\u3059\u308b\u7d99\u7d9a\u7684\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c26\u7ae0\u3000\u672a\u627f\u8a8d\u518d\u751f\u533b\u7642\u3068\u5e79\u7d30\u80de\u30c4\u30fc\u30ea\u30ba\u30e0\u306e\u554f\u984c<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u5e79\u7d30\u80de\u30c4\u30fc\u30ea\u30ba\u30e0\u306e\u5b9f\u614b<\/strong><\/li>\n\n\n\n<li>\u4e3b\u8981\u6e21\u822a\u5148\uff1a\u7c73\u56fd\u3001\u4e2d\u56fd\u3001\u30a4\u30f3\u30c9\u3001\u30bf\u30a4\u3001\u30e1\u30ad\u30b7\u30b3\u7b49<\/li>\n\n\n\n<li>\u8cbb\u7528\uff1a1\u6cbb\u76421\uff5e6\u4e07\u30c9\u30eb\u4ee5\u4e0a<\/li>\n\n\n\n<li>\u5bfe\u8c61\u75be\u60a3\uff1aALS\u3001\u810a\u9ac4\u640d\u50b7\u3001\u81ea\u9589\u75c7\u3001\u591a\u767a\u6027\u786c\u5316\u75c7\u7b49<\/li>\n\n\n\n<li><strong>\u30ea\u30b9\u30af<\/strong><\/li>\n\n\n\n<li>\u611f\u67d3\u75c7\uff08\u7121\u83cc\u64cd\u4f5c\u4e0d\u5099\u306b\u3088\u308b\u7d30\u83cc\u30fb\u771f\u83cc\u611f\u67d3\uff09<\/li>\n\n\n\n<li>\u514d\u75ab\u62d2\u7d76\uff08\u540c\u7a2e\u7d30\u80de\u4f7f\u7528\uff09<\/li>\n\n\n\n<li>\u816b\u760d\u5f62\u6210\uff08\u672a\u7cbe\u88fd\u306e\u5e79\u7d30\u80de\u6295\u4e0e\uff09<\/li>\n\n\n\n<li>\u81d3\u5668\u4e0d\u5168\u30fb\u6b7b\u4ea1\uff08\u91cd\u7be4\u306a\u526f\u4f5c\u7528\uff09<\/li>\n\n\n\n<li><strong>\u65e5\u672c\u306e\u5b89\u78ba\u6cd5\u4e0b\u306e\u8ab2\u984c<\/strong><\/li>\n\n\n\n<li>PRP\u7642\u6cd5\uff08\u7b2c\u4e09\u7a2e\u306e\u5927\u591a\u6570\uff09\u3092\u4e2d\u5fc3\u306b\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u7387\u306e\u4f4e\u3055\u304c\u6307\u6458\u3055\u308c\u3066\u3044\u308b<\/li>\n\n\n\n<li>\u51e6\u7f6e\u4ef6\u6570\u3092\u8003\u616e\u3059\u308b\u3068\u904e\u5c11\u5831\u544a\u306e\u7591\u3044<\/li>\n\n\n\n<li><strong>ISSCR\u306e\u8b66\u544a<\/strong><\/li>\n\n\n\n<li>\u672a\u8a3c\u660e\u6cbb\u7642\uff08unproven treatments\uff09\u306b\u5bfe\u3059\u308b\u660e\u78ba\u306a\u8b66\u9418<\/li>\n\n\n\n<li>\u60a3\u8005\u30fb\u533b\u7642\u8005\u5411\u3051\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u8cc7\u6599\u306e\u63d0\u4f9b<\/li>\n\n\n\n<li><strong>Right to Try\u6cd5\uff08\u7c73\u56fd\uff09<\/strong><\/li>\n\n\n\n<li>2018\u5e74\u6210\u7acb\uff1a\u7d42\u672b\u671f\u60a3\u8005\u304c\u672a\u627f\u8a8d\u6cbb\u7642\u85ac\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b\u6a29\u5229<\/li>\n\n\n\n<li>\u529f\u7f6a\u306e\u4e21\u9762\uff1a\u60a3\u8005\u306e\u81ea\u5f8b\u6027\u5c0a\u91cd vs. \u79d1\u5b66\u7684\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u8efd\u8996<\/li>\n\n\n\n<li><strong>\u81ea\u7531\u8a3a\u7642\u306b\u304a\u3051\u308b\u518d\u751f\u533b\u7642\u306e\u502b\u7406\u7684\u554f\u984c<\/strong><\/li>\n\n\n\n<li>\u533b\u5e2b\u306e\u8aac\u660e\u7fa9\u52d9\u3068\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u306e\u8cea\u306e\u62c5\u4fdd<\/li>\n\n\n\n<li>\u4e0d\u5f53\u306a\u7d4c\u6e08\u7684\u643e\u53d6\u306e\u9632\u6b62<\/li>\n\n\n\n<li>\u9069\u6b63\u5316\u3078\u306e\u63d0\u8a00<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c27\u7ae0\u3000\u7523\u696d\u5316\u30fb\u77e5\u8ca1\u30fb\u533b\u7642\u7d4c\u6e08\u2015\u2015\u6301\u7d9a\u53ef\u80fd\u306a\u518d\u751f\u533b\u7642\u306e\u5b9f\u73fe<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u518d\u751f\u533b\u7642\u306e\u30d3\u30b8\u30cd\u30b9\u30e2\u30c7\u30eb<\/strong><\/li>\n\n\n\n<li><strong>\u81ea\u5bb6\u7d30\u80de\u6cbb\u7642<\/strong>\uff1a\u60a3\u8005\u500b\u5225\u88fd\u9020\u2192\u9ad8\u88fd\u9020\u30b3\u30b9\u30c8\u3001\u30b9\u30b1\u30fc\u30eb\u9650\u754c<\/li>\n\n\n\n<li><strong>\u540c\u7a2e\uff08\u30aa\u30d5\u30b6\u30b7\u30a7\u30eb\u30d5\uff09\u7d30\u80de\u6cbb\u7642<\/strong>\uff1a\u5927\u91cf\u88fd\u9020\u53ef\u80fd\u2192\u30b3\u30b9\u30c8\u524a\u6e1b\u3001\u514d\u75ab\u62d2\u7d76\u30ea\u30b9\u30af<\/li>\n\n\n\n<li><strong>\u907a\u4f1d\u5b50\u6cbb\u7642\u306e\u4fa1\u683c\u554f\u984c<\/strong><\/li>\n\n\n\n<li>Casgevy\uff1a\u7d04220\u4e07\u30c9\u30eb\uff081\u56de\u6295\u4e0e\uff09<\/li>\n\n\n\n<li>Lyfgenia\uff1a\u7d04310\u4e07\u30c9\u30eb<\/li>\n\n\n\n<li>CAR-T\uff1a30\uff5e50\u4e07\u30c9\u30eb<\/li>\n\n\n\n<li>\u533b\u7642\u5236\u5ea6\u306e\u6301\u7d9a\u53ef\u80fd\u6027\u3078\u306e\u6df1\u523b\u306a\u61f8\u5ff5<\/li>\n\n\n\n<li><strong>\u77e5\u7684\u8ca1\u7523\u6226\u7565<\/strong><\/li>\n\n\n\n<li>\u7279\u8a31\uff08\u88fd\u9020\u65b9\u6cd5\u3001\u7d30\u80de\u682a\u3001\u907a\u4f1d\u5b50\u914d\u5217\u3001\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\uff09<\/li>\n\n\n\n<li>\u30ce\u30a6\u30cf\u30a6\u4fdd\u8b77\uff08\u516c\u958b\u3057\u306a\u3044\u88fd\u9020\u5de5\u7a0b\u306e\u79d8\u533f\uff09<\/li>\n\n\n\n<li>\u30e9\u30a4\u30bb\u30f3\u30b9\u6226\u7565\uff08\u30af\u30ed\u30b9\u30e9\u30a4\u30bb\u30f3\u30b9\u3001\u30a8\u30af\u30b9\u30af\u30eb\u30fc\u30b7\u30d6\u30e9\u30a4\u30bb\u30f3\u30b9\uff09<\/li>\n\n\n\n<li><strong>\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u306e\u8cc7\u672c\u653f\u7b56<\/strong><\/li>\n\n\n\n<li>Heartseed\u2013Novo Nordisk\u63d0\u643a\uff1a\u6700\u59275.98\u5104\u30c9\u30eb\uff082025\u5e74\uff09<\/li>\n\n\n\n<li>\u56fd\u5185\u518d\u751f\u533b\u7642\u30d9\u30f3\u30c1\u30e3\u30fc\u3078\u306e\u6295\u8cc7\u52d5\u5411<\/li>\n\n\n\n<li><strong>EU\u5e02\u5834\u64a4\u9000\u554f\u984c\u304b\u3089\u5b66\u3076\u5546\u696d\u30e2\u30c7\u30eb\u306e\u8a2d\u8a08<\/strong>\uff08\u7b2c13\u7ae0\u3068\u9023\u643a\uff09<\/li>\n\n\n\n<li>HTA\uff08\u533b\u7642\u6280\u8853\u8a55\u4fa1\uff09\u5bfe\u5fdc\u306e\u65e9\u671f\u8a08\u753b<\/li>\n\n\n\n<li>\u4fa1\u683c\u8a2d\u5b9a\u306e\u73fe\u5b9f\u7684\u306a\u898b\u7a4d\u308a<\/li>\n\n\n\n<li>\u30a2\u30af\u30bb\u30b9\u683c\u5dee\uff08EU\uff1a\u30c9\u30a4\u30c4\u9ad8\u30a2\u30af\u30bb\u30b9\u6027 vs. \u4e00\u90e8\u52a0\u76df\u56fd\u3067\u306f\u672a\u4e0a\u5e02\uff09<\/li>\n\n\n\n<li><strong>\u65e5\u672c\u306e\u7814\u7a76\u958b\u767a\u4e88\u7b97<\/strong><\/li>\n\n\n\n<li>FY2024 \u5e79\u7d30\u80de\u30fb\u907a\u4f1d\u5b50\u6cbb\u7642\u7814\u7a76\u8cbb\uff1a\u7d04200\u5104\u5186\uff08\u56fd\u969b\u7af6\u4e89\u4e0a\u4e0d\u5341\u5206\u3068\u306e\u6307\u6458\uff09<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u7b2c\u2165\u90e8\u3000\u6700\u5148\u7aef\u6280\u8853\u3068\u5c06\u6765\u5c55\u671b\uff08\u7b2c28\uff5e30\u7ae0\uff09<\/h2>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c28\u7ae0\u30003D\u30d0\u30a4\u30aa\u30d7\u30ea\u30f3\u30c6\u30a3\u30f3\u30b0\u3068\u30aa\u30eb\u30ac\u30ce\u30a4\u30c9\u2015\u2015\u81d3\u5668\u88fd\u9020\u3078\u306e\u9053\u7a0b<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u30d0\u30a4\u30aa\u30d7\u30ea\u30f3\u30c6\u30a3\u30f3\u30b0\u6280\u8853<\/strong><\/li>\n\n\n\n<li>\u62bc\u51fa\u578b\uff08Extrusion-based\uff09\uff1a\u6700\u3082\u666e\u53ca\u3001\u9ad8\u7d30\u80de\u5bc6\u5ea6<\/li>\n\n\n\n<li>\u30a4\u30f3\u30af\u30b8\u30a7\u30c3\u30c8\u578b\uff08Inkjet-based\uff09\uff1a\u9ad8\u7cbe\u5ea6\u3001\u4f4e\u7c98\u5ea6\u30a4\u30f3\u30af<\/li>\n\n\n\n<li>\u5149\u9020\u5f62\u578b\uff08Stereolithography\/DLP\uff09\uff1a\u9ad8\u89e3\u50cf\u5ea6<\/li>\n\n\n\n<li>LIFT\u578b\uff08Laser-induced forward transfer\uff09\uff1a\u30ec\u30fc\u30b6\u30fc\u8a98\u8d77\u8ee2\u5199<\/li>\n\n\n\n<li>\u30dc\u30ea\u30e5\u30e1\u30c8\u30ea\u30c3\u30af\u578b\uff08Volumetric\uff09\uff1a\u5168\u4f53\u540c\u6642\u9020\u5f62\uff08\u8d85\u9ad8\u901f\uff09<\/li>\n\n\n\n<li>4D\u30d0\u30a4\u30aa\u30d7\u30ea\u30f3\u30c6\u30a3\u30f3\u30b0\uff1a\u523a\u6fc0\u5fdc\u7b54\u6027\u306e\u5f62\u72b6\u30fb\u6a5f\u80fd\u5909\u5316<\/li>\n\n\n\n<li><strong>\u30d0\u30a4\u30aa\u30a4\u30f3\u30af<\/strong><\/li>\n\n\n\n<li>GelMA\uff08\u30bc\u30e9\u30c1\u30f3\u30e1\u30bf\u30af\u30ea\u30ec\u30fc\u30c8\uff09\uff1a\u5149\u67b6\u6a4b\u3001\u751f\u4f53\u89aa\u548c\u6027<\/li>\n\n\n\n<li>\u30a2\u30eb\u30ae\u30f3\u9178\uff08Alginate\uff09\uff1a\u30ab\u30eb\u30b7\u30a6\u30e0\u67b6\u6a4b\u3001\u4f4e\u30b3\u30b9\u30c8<\/li>\n\n\n\n<li>\u8131\u7d30\u80de\u5316ECM\uff08dECM bioink\uff09\uff1a\u81d3\u5668\u56fa\u6709\u306e\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u6210\u5206\u3092\u542b\u3080<\/li>\n\n\n\n<li><strong>\u30aa\u30eb\u30ac\u30ce\u30a4\u30c9\u6280\u8853<\/strong><\/li>\n\n\n\n<li>\u8133\u3001\u809d\u81d3\u3001\u8178\u3001\u814e\u81d3\u3001\u5fc3\u81d3\u3001\u80ba\u3001\u7db2\u819c\u3001\u304c\u3093\u7b49<\/li>\n\n\n\n<li>Organ-on-a-chip\uff1a\u30de\u30a4\u30af\u30ed\u6d41\u4f53\u30c7\u30d0\u30a4\u30b9\u4e0a\u3067\u306e\u81d3\u5668\u6a5f\u80fd\u518d\u73fe<\/li>\n\n\n\n<li>\u30a2\u30bb\u30f3\u30d6\u30ed\u30a4\u30c9\uff08Assembloid\uff09\uff1a\u8907\u6570\u30aa\u30eb\u30ac\u30ce\u30a4\u30c9\u306e\u878d\u5408<\/li>\n\n\n\n<li>\u60a3\u8005\u7531\u6765\u304c\u3093\u30aa\u30eb\u30ac\u30ce\u30a4\u30c9\u306b\u3088\u308b\u500b\u5225\u5316\u85ac\u7269\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0<\/li>\n\n\n\n<li><strong>\u81e8\u5e8a\u5fdc\u7528\u3078\u306e\u8ab2\u984c<\/strong><\/li>\n\n\n\n<li>\u8840\u7ba1\u5316\uff08vascularization\uff09\uff1a\u9178\u7d20\u30fb\u6804\u990a\u306e\u81d3\u5668\u5185\u5747\u4e00\u4f9b\u7d66<\/li>\n\n\n\n<li>\u6804\u990a\u8f38\u9001\uff08>1mm\u4ee5\u4e0a\u306e\u7d44\u7e54\u3067\u306f\u62e1\u6563\u4e0d\u8db3\uff09<\/li>\n\n\n\n<li>\u518d\u73fe\u6027\uff08\u30d0\u30c3\u30c1\u9593\u5909\u52d5\uff09<\/li>\n\n\n\n<li>\u80ce\u5150\u69d8\u72b6\u614b\uff08fetal-like\uff09\u304b\u3089\u306e\u6210\u719f\u5316\uff08maturation\uff09<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c29\u7ae0\u3000\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u30fbIn vivo\u30ea\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u30fb\u6b21\u4e16\u4ee3\u9001\u9054\u6280\u8853<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\uff08\u7d30\u80de\u5916\u5c0f\u80de\u3001EV\uff09\u7642\u6cd5\u306e\u73fe\u72b6<\/strong><\/li>\n\n\n\n<li>2024\u5e74\u521d\u982d\u6642\u70b9\u3067\u7d04240\u4ef6\u306eEV\u81e8\u5e8a\u8a66\u9a13\u767b\u9332\u3001\u7d0450\u4ef6\u304c\u4ecb\u5165\u8a66\u9a13<\/li>\n\n\n\n<li>\u4e3b\u8981\u30d1\u30a4\u30d7\u30e9\u30a4\u30f3\uff1a\n<ul class=\"wp-block-list\">\n<li>CAP1002\/deramiocel\uff08DMD Phase III\uff09<\/li>\n\n\n\n<li>ExoFlo\uff08ARDS\u6cbb\u7642\uff09<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>FDA\u672a\u627f\u8a8d\u3060\u304cISEV\uff08International Society for Extracellular Vesicles\uff09MISEV\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u6a19\u6e96<\/li>\n\n\n\n<li><strong>\u30a8\u30f3\u30b8\u30cb\u30a2\u30fc\u30c9\u30a8\u30af\u30bd\u30bd\u30fc\u30e0<\/strong><\/li>\n\n\n\n<li>siRNA\u642d\u8f09\uff1a\u7279\u5b9a\u907a\u4f1d\u5b50\u306e\u30ce\u30c3\u30af\u30c0\u30a6\u30f3<\/li>\n\n\n\n<li>miRNA\u642d\u8f09\uff1a\u907a\u4f1d\u5b50\u767a\u73fe\u306e\u8abf\u7bc0<\/li>\n\n\n\n<li>CRISPR\u642d\u8f09\uff1a\u30b2\u30ce\u30e0\u7de8\u96c6\u30c4\u30fc\u30eb\u306e\u9001\u9054<\/li>\n\n\n\n<li>\u8868\u9762\u4fee\u98fe\u306b\u3088\u308b\u30bf\u30fc\u30b2\u30c6\u30a3\u30f3\u30b0\uff08\u816b\u760d\u3001\u8133\u306a\u3069\u7279\u5b9a\u7d44\u7e54\u3078\u306e\u6307\u5411\u6027\u4ed8\u4e0e\uff09<\/li>\n\n\n\n<li><strong>In vivo\u30ea\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0<\/strong><\/li>\n\n\n\n<li>\u30ca\u30ce\u7c92\u5b50\u30fb\u30a6\u30a4\u30eb\u30b9\u30d9\u30af\u30bf\u30fc\u306b\u3088\u308b\u4f53\u5185\u76f4\u63a5\u907a\u4f1d\u5b50\u5c0e\u5165<\/li>\n\n\n\n<li>\u4f53\u5185\u306e\u4f53\u7d30\u80de\u3092\u76f4\u63a5\u591a\u80fd\u6027\u7d30\u80de\u307e\u305f\u306f\u76ee\u7684\u7d30\u80de\u306b\u30ea\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0<\/li>\n\n\n\n<li>\u4e3b\u8981\u7814\u7a76\u6a5f\u95a2\uff1aInterius BioTherapeutics\u3001Umoja Biopharma<\/li>\n\n\n\n<li><strong>mRNA\u30d9\u30fc\u30b9\u30ea\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0<\/strong><\/li>\n\n\n\n<li>\u4e00\u904e\u6027\u767a\u73fe\u306b\u3088\u308b\u5b89\u5168\u6027\uff08\u30b2\u30ce\u30e0\u3078\u306e\u7d44\u307f\u8fbc\u307f\u306a\u3057\uff09<\/li>\n\n\n\n<li>COVID-19 mRNA\u30ef\u30af\u30c1\u30f3\u6280\u8853\u306e\u518d\u751f\u533b\u7642\u3078\u306e\u5fdc\u7528<\/li>\n\n\n\n<li><strong>\u30c0\u30a4\u30ec\u30af\u30c8\u30ea\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0<\/strong><\/li>\n\n\n\n<li>\u5e79\u7d30\u80de\u3092\u7d4c\u7531\u305b\u305a\u4f53\u7d30\u80de\u3092\u76f4\u63a5\u76ee\u7684\u7d30\u80de\u306b\u5909\u63db<\/li>\n\n\n\n<li>\u7dda\u7dad\u82bd\u7d30\u80de\u2192\u5fc3\u7b4b\u69d8\u7d30\u80de\uff08Ieda M, Cell 2010\uff09<\/li>\n\n\n\n<li>\u76ae\u819a\u7d30\u80de\u2192\u30cb\u30e5\u30fc\u30ed\u30f3\uff08\u795e\u7d4c\u76f4\u63a5\u5909\u63db\uff09<\/li>\n\n\n\n<li>\u816b\u760d\u5f62\u6210\u30ea\u30b9\u30af\u3092\u56de\u907f\u3067\u304d\u308b\u53ef\u80fd\u6027<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u7b2c30\u7ae0\u3000AI\u30fb\u30c7\u30b8\u30bf\u30eb\u6280\u8853\u3068\u518d\u751f\u533b\u7642\u306e\u672a\u6765\u2015\u20152030\u5e74\u3078\u306e\u5c55\u671b<\/h3>\n\n\n\n<p><strong>\u4e3b\u8981\u30c8\u30d4\u30c3\u30af\uff1a<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>AI\u306b\u3088\u308b\u518d\u751f\u533b\u7642\u306e\u9ad8\u5ea6\u5316<\/strong><\/li>\n\n\n\n<li>\u30b2\u30ce\u30e0\u30c7\u30fc\u30bf\u89e3\u6790\uff08\u5909\u7570\u89e3\u6790\u3001\u30d0\u30ea\u30a2\u30f3\u30c8\u5206\u985e\u306e\u81ea\u52d5\u5316\uff09<\/li>\n\n\n\n<li>\u30d0\u30a4\u30aa\u30de\u30fc\u30ab\u30fc\u540c\u5b9a\uff08\u5358\u7d30\u80deRNAseq\u00d7\u6a5f\u68b0\u5b66\u7fd2\uff09<\/li>\n\n\n\n<li>\u5e79\u7d30\u80de\u5206\u5316\u4e88\u6e2c\uff08\u5f62\u614b\u5b66\u7fd2\u30e2\u30c7\u30eb\uff09<\/li>\n\n\n\n<li>\u500b\u5225\u5316\u6cbb\u7642\u6226\u7565\uff08\u60a3\u8005\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306b\u57fa\u3065\u304f\u6700\u9069\u7d30\u80de\u88fd\u54c1\u306e\u9078\u629e\uff09<\/li>\n\n\n\n<li><strong>AI\u81ea\u52d5\u7d30\u80de\u57f9\u990a\u30b7\u30b9\u30c6\u30e0<\/strong><\/li>\n\n\n\n<li>Cellrino Biotech\uff1a\u5f62\u614b\u5b66\u7fd2\uff0b\u30ec\u30fc\u30b6\u30fc\u7570\u5e38\u7d30\u80de\u9664\u53bb<\/li>\n\n\n\n<li>\u7121\u4eba\u57f9\u990a\u3001\u54c1\u8cea\u306e\u81ea\u52d5\u7ba1\u7406<\/li>\n\n\n\n<li>GMP\u9069\u5408\u306e\u88fd\u9020\u81ea\u52d5\u5316<\/li>\n\n\n\n<li><strong>AI\u5275\u85ac<\/strong><\/li>\n\n\n\n<li>\u75be\u60a3\u7279\u7570\u7684iPS\u7d30\u80de\u3092\u7528\u3044\u305f\u85ac\u7269\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u306e\u81ea\u52d5\u5316<\/li>\n\n\n\n<li>AlphaFold\uff08\u30bf\u30f3\u30d1\u30af\u8cea\u69cb\u9020\u4e88\u6e2c\uff09\u3068\u306e\u7d71\u5408<\/li>\n\n\n\n<li>\u60a3\u8005\u7531\u6765\u30aa\u30eb\u30ac\u30ce\u30a4\u30c9\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u306e\u9ad8\u30b9\u30eb\u30fc\u30d7\u30c3\u30c8\u5316<\/li>\n\n\n\n<li><strong>\u540c\u7a2e\u30fb\u30aa\u30d5\u30b6\u30b7\u30a7\u30eb\u30d5\u7d30\u80de\u6cbb\u7642\u306e\u6a19\u6e96\u5316<\/strong><\/li>\n\n\n\n<li>HLA\u5de5\u5b66\u7684\u300c\u30e6\u30cb\u30d0\u30fc\u30b5\u30eb\u30c9\u30ca\u30fc\u300diPSC\u682a\u306e\u958b\u767a<\/li>\n\n\n\n<li>CRISPR\u7de8\u96c6\u306b\u3088\u308bHLA-A\/B\/C\u30fbHLA-DP\/DQ\/DR\u9664\u53bb<\/li>\n\n\n\n<li>CD47\u904e\u5270\u767a\u73fe\u306b\u3088\u308b\u81ea\u7136\u514d\u75ab\u7d30\u80de\u306e\u56de\u907f<\/li>\n\n\n\n<li><strong>iPSC\u7531\u6765\u8840\u5c0f\u677f\u306e\u81ea\u5bb6\u8f38\u8840<\/strong><\/li>\n\n\n\n<li>CiRA \u6c5f\u85e4\u6d69\u4e4b\u6559\u6388\uff1a2027\u5e74\u4ee5\u964d\u306e\u6b21\u76f8\u8a66\u9a13\u76ee\u6a19<\/li>\n\n\n\n<li><strong>\u518d\u751f\u533b\u7642\u306e\u6c11\u4e3b\u5316\u306b\u5411\u3051\u305f\u8ab2\u984c\u3068\u5c55\u671b<\/strong><\/li>\n\n\n\n<li>\u30a2\u30af\u30bb\u30b9\u683c\u5dee\u306e\u89e3\u6d88\uff08\u5148\u9032\u56fd\u3068\u9014\u4e0a\u56fd\u3001\u90fd\u5e02\u3068\u5730\u65b9\uff09<\/li>\n\n\n\n<li>\u30b3\u30b9\u30c8\u524a\u6e1b\uff08\u88fd\u9020\u306e\u81ea\u52d5\u5316\u30fb\u5927\u91cf\u751f\u7523\u5316\uff09<\/li>\n\n\n\n<li>\u898f\u5236\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u30cf\u30fc\u30e2\u30ca\u30a4\u30bc\u30fc\u30b7\u30e7\u30f3<\/li>\n\n\n\n<li>2030\u5e74\u3078\u306e\u5c55\u671b\uff1a\u81ea\u5bb6\u88fd\u54c1\u304b\u3089\u540c\u7a2e\u88fd\u54c1\u3078\u306e\u30d1\u30e9\u30c0\u30a4\u30e0\u30b7\u30d5\u30c8<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u25a0 \u672c\u69cb\u6210\u304c\u65e2\u5b58\u6559\u79d1\u66f8\u3068\u7570\u306a\u308b5\u3064\u306e\u7279\u5fb4<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u6761\u4ef6\u4ed8\u304d\u627f\u8a8d\u5236\u5ea6\u306e\u300c\u6210\u529f\u3068\u5931\u6557\u300d\u3092\u6559\u6750\u5316<\/strong>\uff1a\u30cf\u30fc\u30c8\u30b7\u30fc\u30c8\u30fb\u30b3\u30e9\u30c6\u30b8\u30a7\u30f3\u306e\u627f\u8a8d\u5931\u52b9\u4e8b\u4f8b\u3068\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u30fb\u30ea\u30cf\u30fc\u30c8\u306e\u627f\u8a8d\u6210\u529f\u4e8b\u4f8b\u3092\u5bfe\u6bd4\u7684\u306b\u6271\u3044\u3001\u5236\u5ea6\u306e\u6a5f\u80fd\u3068\u9650\u754c\u3092\u5b9f\u8a3c\u7684\u306b\u5b66\u3079\u308b\u69cb\u6210\u3068\u3057\u305f\u3002<\/li>\n\n\n\n<li><strong>iPS\u7d30\u80de\u306e\u81e8\u5e8a\u5b9f\u88c5\u3092\u5404\u8a3a\u7642\u79d1\u7ae0\u306b\u7d71\u5408<\/strong>\uff1a\u5faa\u74b0\u5668\uff08\u30ea\u30cf\u30fc\u30c8\uff09\u3001\u795e\u7d4c\uff08\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\uff09\u3001\u773c\u79d1\uff08RPE\u3001\u89d2\u819c\uff09\u306e\u5404\u7ae0\u3067\u5177\u4f53\u7684\u306b\u6271\u3046\u3053\u3068\u3067\u3001\u81e8\u5e8a\u533b\u306e\u8a3a\u7642\u5224\u65ad\u306b\u76f4\u7d50\u3059\u308b\u69cb\u6210\u3068\u3057\u305f\u3002<\/li>\n\n\n\n<li><strong>\u56fd\u969b\u898f\u5236\u6bd4\u8f03\u3092\u72ec\u7acb\u90e8\u3068\u3057\u3066\u8a2d\u8a08<\/strong>\uff1a\u56fd\u969b\u5171\u540c\u6cbb\u9a13\u306e\u8a2d\u8a08\u3084\u30b0\u30ed\u30fc\u30d0\u30eb\u88fd\u54c1\u958b\u767a\u306e\u610f\u601d\u6c7a\u5b9a\u306b\u5fc5\u8981\u306a\u4e09\u6975\u6bd4\u8f03\uff08FDA\/EMA\/PMDA\uff09\u3092\u4f53\u7cfb\u7684\u306b\u30ab\u30d0\u30fc\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>2024\u5e74\u5b89\u78ba\u6cd5\u6539\u6b63\u30fb2026\u5e74iPS\u88fd\u54c1\u627f\u8a8d\u3068\u3044\u3046\u6700\u65b0\u306e\u8ee2\u63db\u70b9\u3092\u53cd\u6620<\/strong>\uff1ain vivo\u907a\u4f1d\u5b50\u6cbb\u7642\u306e\u898f\u5236\u5bfe\u8c61\u5316\u3001\u59d4\u54e1\u4f1a\u76e3\u7763\u306e\u5f37\u5316\u3001\u4e16\u754c\u521d\u306eiPS\u7531\u6765\u88fd\u54c1\u627f\u8a8d\u3068\u3044\u3046\u6b74\u53f2\u7684\u4e8b\u8c61\u3092\u53ce\u9332\u3002<\/li>\n\n\n\n<li><strong>\u7523\u696d\u5316\u30fb\u533b\u7642\u7d4c\u6e08\u30fb\u793e\u4f1a\u5b9f\u88c5\u306e\u7ae0\u3092\u7d71\u5408<\/strong>\uff1aEU\u306eATMP\u5e02\u5834\u64a4\u9000\u554f\u984c\u3092\u542b\u3080\u5546\u696d\u5316\u306e\u73fe\u5b9f\u3092\u4ee3\u8868\u7406\u4e8b\u30ec\u30d9\u30eb\u306e\u8aad\u8005\u306e\u7d4c\u55b6\u5224\u65ad\u57fa\u76e4\u3068\u3059\u308b\u3002<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u25a0 \u518d\u751f\u533b\u7642 \u5bfe\u5fdc\u75be\u60a3\u30fb\u6cbb\u7642\u6cd5\u30ea\u30b9\u30c8<\/h2>\n\n\n\n<p>\u4f5c\u6210\u65e5\uff1a2026\u5e743\u670828\u65e5 \uff5c \u5bfe\u8c61\u8a3a\u7642\u79d1\uff1a10\u79d1 \uff5c \u53ce\u8f09\u75be\u60a3\u6570\uff1a38\u75be\u60a3<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. \u6574\u5f62\u5916\u79d1\u30fb\u30b9\u30dd\u30fc\u30c4\u533b\u5b66<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u75be\u60a3\u540d<\/th><th>\u6cbb\u7642\u30a2\u30d7\u30ed\u30fc\u30c1<\/th><th>\u4e3b\u306a\u6cbb\u7642\u6cd5\u30fb\u88fd\u54c1\u540d<\/th><\/tr><\/thead><tbody><tr><td>\u5909\u5f62\u6027\u819d\u95a2\u7bc0\u75c7<\/td><td>\u81ea\u5bb6\u57f9\u990a\u8edf\u9aa8\u79fb\u690d\uff08ACI\uff09\/ PRP\u7642\u6cd5<\/td><td>ACI\uff08\u81ea\u5bb6\u57f9\u990a\u8edf\u9aa8\u79fb\u690d\uff09\u3001MACI\uff08\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u8a98\u5c0e\u578bACI\uff09\u3001PRP\u6ce8\u5c04\uff08\u591a\u8840\u5c0f\u677f\u8840\u6f3f\uff09<\/td><\/tr><tr><td>\u5909\u5f62\u6027\u80a1\u95a2\u7bc0\u75c7<\/td><td>\u9aa8\u9ac4\u7531\u6765\u9593\u8449\u7cfb\u5e79\u7d30\u80de\u6ce8\u5c04<\/td><td>BM-MSC\u7642\u6cd5<\/td><\/tr><tr><td>\u534a\u6708\u677f\u640d\u50b7<\/td><td>PRP \/ \u9593\u8449\u7cfb\u5e79\u7d30\u80de\u79fb\u690d<\/td><td>PRP\u7642\u6cd5\u3001MSC\u79fb\u690d<\/td><\/tr><tr><td>\u976d\u5e2f\u65ad\u88c2\uff08ACL\u7b49\uff09<\/td><td>PRP\u6ce8\u5c04\u30fb\u5e79\u7d30\u80de\u88dc\u52a9\u4fee\u5fa9<\/td><td>PRP\u5f37\u5316\u7e2b\u5408\u8853<\/td><\/tr><tr><td>\u9aa8\u58ca\u6b7b\u30fb\u507d\u95a2\u7bc0<\/td><td>\u9aa8\u9ac4\u6fc3\u7e2e\u6db2\u6ce8\u5165<\/td><td>BMAC\u7642\u6cd5\uff08\u9aa8\u9ac4\u5438\u5f15\u6fc3\u7e2e\u6db2\uff09<\/td><\/tr><tr><td>\u8171\u677f\u65ad\u88c2<\/td><td>PRP\u30fb\u5e79\u7d30\u80de\u6ce8\u5c04<\/td><td>PRP\u8171\u677f\u4fee\u5fa9\u88dc\u52a9<\/td><\/tr><tr><td>\u690e\u9593\u677f\u5909\u6027\u75c7<\/td><td>\u9593\u8449\u7cfb\u5e79\u7d30\u80de\u690e\u9593\u677f\u5185\u6ce8\u5165<\/td><td>MSC\u690e\u9593\u677f\u518d\u751f\u7642\u6cd5<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">2. \u5faa\u74b0\u5668\u5185\u79d1\u30fb\u5fc3\u81d3\u5916\u79d1<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u75be\u60a3\u540d<\/th><th>\u6cbb\u7642\u30a2\u30d7\u30ed\u30fc\u30c1<\/th><th>\u4e3b\u306a\u6cbb\u7642\u6cd5\u30fb\u88fd\u54c1\u540d<\/th><\/tr><\/thead><tbody><tr><td>\u5fc3\u7b4b\u6897\u585e\u5f8c\u5fc3\u4e0d\u5168<\/td><td>\u9aa8\u683c\u7b4b\u82bd\u7d30\u80de\u79fb\u690d\u30fb\u5fc3\u7b4b\u7d30\u80de\u30b7\u30fc\u30c8\u79fb\u690d<\/td><td>\u30cf\u30fc\u30c8\u30b7\u30fc\u30c8\u00ae\uff08\u30c6\u30eb\u30e2\uff09\u203b\u627f\u8a8d\u5931\u52b9\u3001\u30ea\u30cf\u30fc\u30c8\u00ae\uff08Cuorips\u793e\uff092026\u5e743\u6708\u627f\u8a8d<\/td><\/tr><tr><td>\u62e1\u5f35\u578b\u5fc3\u7b4b\u75c7<\/td><td>\u9aa8\u9ac4\u5e79\u7d30\u80de\u51a0\u52d5\u8108\u5185\u6ce8\u5165<\/td><td>TACT\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb<\/td><\/tr><tr><td>\u672b\u68a2\u52d5\u8108\u75be\u60a3\uff08\u91cd\u75c7\u865a\u8840\u80a2\uff09<\/td><td>\u9aa8\u9ac4\u30fb\u672b\u68a2\u8840\u5358\u6838\u7403\u7d30\u80de\u6ce8\u5c04<\/td><td>TACT\uff08\u6cbb\u7642\u7684\u8840\u7ba1\u65b0\u751f\uff09\u3001PROVAST\u8a66\u9a13<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">3. \u76ae\u819a\u79d1\u30fb\u5f62\u6210\u5916\u79d1\u30fb\u7f8e\u5bb9\u5916\u79d1<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u75be\u60a3\u540d<\/th><th>\u6cbb\u7642\u30a2\u30d7\u30ed\u30fc\u30c1<\/th><th>\u4e3b\u306a\u6cbb\u7642\u6cd5\u30fb\u88fd\u54c1\u540d<\/th><\/tr><\/thead><tbody><tr><td>\u96e3\u6cbb\u6027\u5275\u50b7\u30fb\u8925\u7621<\/td><td>PRP \/ \u57f9\u990a\u76ae\u819a\u79fb\u690d<\/td><td>\u30b8\u30a7\u30a4\u30b9\u00ae\uff08J-TEC\uff09\u3001PRP\u5275\u50b7\u6cbb\u7642<\/td><\/tr><tr><td>\u71b1\u50b7\uff08\u5e83\u7bc4\u56f2\uff09<\/td><td>\u81ea\u5bb6\u57f9\u990a\u8868\u76ae\u79fb\u690d<\/td><td>\u30b8\u30a7\u30a4\u30b9\u00ae\u3001\u57f9\u990a\u8868\u76ae\uff08CEA\uff09<\/td><\/tr><tr><td>\u8131\u6bdb\u75c7\uff08AGA\u7b49\uff09<\/td><td>PRP\u982d\u76ae\u6ce8\u5c04<\/td><td>PRP\u767a\u6bdb\u7642\u6cd5\u3001AGA-PRP\u7642\u6cd5<\/td><\/tr><tr><td>\u7622\u75d5\u30fb\u30b1\u30ed\u30a4\u30c9<\/td><td>\u8102\u80aa\u7531\u6765\u5e79\u7d30\u80de\u79fb\u690d<\/td><td>ADSC\uff08\u8102\u80aa\u7531\u6765\u5e79\u7d30\u80de\uff09\u7642\u6cd5<\/td><\/tr><tr><td>\u76ae\u819a\u6f70\u760d<\/td><td>\u57f9\u990a\u771f\u76ae\u30fb\u7f8a\u819c\u79fb\u690d<\/td><td>\u30c6\u30eb\u30c0\u30fc\u30df\u30b9\u00ae\u3001\u30a2\u30d7\u30ea\u30b0\u30e9\u30d5<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">4. \u795e\u7d4c\u5185\u79d1\u30fb\u8133\u795e\u7d4c\u5916\u79d1<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u75be\u60a3\u540d<\/th><th>\u6cbb\u7642\u30a2\u30d7\u30ed\u30fc\u30c1<\/th><th>\u4e3b\u306a\u6cbb\u7642\u6cd5\u30fb\u88fd\u54c1\u540d<\/th><\/tr><\/thead><tbody><tr><td>\u810a\u9ac4\u640d\u50b7<\/td><td>\u30d2\u30c8iPS\/ES\u7531\u6765\u795e\u7d4c\u524d\u99c6\u7d30\u80de\u79fb\u690d<\/td><td>SCiStar\u8a66\u9a13\uff08Asterias\uff09\u3001\u6176\u61c9iPS\u810a\u9ac4\u7814\u7a76\uff08\u30b1\u30a4\u30d5\u30a1\u30fc\u30de\uff09<\/td><\/tr><tr><td>\u30d1\u30fc\u30ad\u30f3\u30bd\u30f3\u75c5<\/td><td>\u30c9\u30d1\u30df\u30f3\u7523\u751f\u7d30\u80de\u79fb\u690d\uff08iPS\u7531\u6765\uff09<\/td><td>\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u00ae\uff08\u4f4f\u53cb\u30d5\u30a1\u30fc\u30de\uff092026\u5e743\u6708\u627f\u8a8d<\/td><\/tr><tr><td>\u8133\u6897\u585e\u5f8c\u5f8c\u907a\u75c7<\/td><td>\u9aa8\u9ac4\u5e79\u7d30\u80de\u9759\u8108\u5185\u6295\u4e0e<\/td><td>\u30a2\u30af\u30fc\u30b4\u00ae\uff08SanBio SB623\uff092024\u5e747\u6708\u627f\u8a8d\u3001MultiStem\u00ae<\/td><\/tr><tr><td>\u7b4b\u840e\u7e2e\u6027\u5074\u7d22\u786c\u5316\u75c7\uff08ALS\uff09<\/td><td>\u9593\u8449\u7cfb\u5e79\u7d30\u80de\u9ac4\u8154\u5185\u6295\u4e0e<\/td><td>NurOwn\u00ae\uff08BrainStorm\uff09<\/td><\/tr><tr><td>\u52a0\u9f62\u9ec4\u6591\u5909\u6027<\/td><td>RPE\u7d30\u80de\u79fb\u690d\uff08iPS\u7531\u6765\uff09<\/td><td>\u4f4f\u53cb\u30d5\u30a1\u30fc\u30deiPS-RPE\u79fb\u690d<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">5. \u8840\u6db2\u5185\u79d1\u30fb\u514d\u75ab\u79d1\u30fb\u816b\u760d\u5185\u79d1<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u75be\u60a3\u540d<\/th><th>\u6cbb\u7642\u30a2\u30d7\u30ed\u30fc\u30c1<\/th><th>\u4e3b\u306a\u6cbb\u7642\u6cd5\u30fb\u88fd\u54c1\u540d<\/th><\/tr><\/thead><tbody><tr><td>\u8840\u6db2\u304c\u3093\uff08\u767d\u8840\u75c5\u30fb\u30ea\u30f3\u30d1\u816b\uff09<\/td><td>\u9020\u8840\u5e79\u7d30\u80de\u79fb\u690d \/ CAR-T\u7d30\u80de\u7642\u6cd5<\/td><td>\u540c\u7a2e\u9020\u8840\u5e79\u7d30\u80de\u79fb\u690d\uff08allo-HSCT\uff09\u3001\u30ad\u30e0\u30ea\u30a2\u00ae\u3001\u30a4\u30a8\u30b9\u30ab\u30eb\u30bf\u00ae\u3001\u30d6\u30ec\u30e4\u30f3\u30b8\u00ae<\/td><\/tr><tr><td>\u591a\u767a\u6027\u9aa8\u9ac4\u816b<\/td><td>\u81ea\u5bb6\u9020\u8840\u5e79\u7d30\u80de\u79fb\u690d\uff0bCAR-T<\/td><td>\u30a2\u30d9\u30af\u30de\u00ae\uff08Abecma\uff09\u3001\u30ab\u30fc\u30d3\u30af\u30c6\u30a3\u00ae\uff08Carvykti\uff09<\/td><\/tr><tr><td>\u518d\u751f\u4e0d\u826f\u6027\u8ca7\u8840<\/td><td>\u9020\u8840\u5e79\u7d30\u80de\u79fb\u690d<\/td><td>allo-HSCT<\/td><\/tr><tr><td>\u514d\u75ab\u4e0d\u5168\u75be\u60a3\uff08SCID\u7b49\uff09<\/td><td>\u9020\u8840\u5e79\u7d30\u80de\u907a\u4f1d\u5b50\u6cbb\u7642<\/td><td>Strimvelis\u00ae\uff08GSK\uff09\u3001Libmeldy\u00ae<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">6. \u6d88\u5316\u5668\u5185\u79d1\u30fb\u5916\u79d1<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u75be\u60a3\u540d<\/th><th>\u6cbb\u7642\u30a2\u30d7\u30ed\u30fc\u30c1<\/th><th>\u4e3b\u306a\u6cbb\u7642\u6cd5\u30fb\u88fd\u54c1\u540d<\/th><\/tr><\/thead><tbody><tr><td>\u30af\u30ed\u30fc\u30f3\u75c5\uff08\u75d4\u763b\u5408\u4f75\uff09<\/td><td>\u8102\u80aa\u7531\u6765\u5e79\u7d30\u80de\u79fb\u690d<\/td><td>Alofisel\u00ae\uff08darvadstrocel\uff09<\/td><\/tr><tr><td>\u809d\u786c\u5909\u30fb\u809d\u4e0d\u5168<\/td><td>\u9aa8\u9ac4\u5e79\u7d30\u80de\u30fb\u809d\u524d\u99c6\u7d30\u80de\u79fb\u690d<\/td><td>\u9aa8\u9ac4\u7d30\u80de\u7d4c\u813e\u52d5\u8108\u6295\u4e0e\uff08\u81e8\u5e8a\u7814\u7a76\uff09<\/td><\/tr><tr><td>\u6f70\u760d\u6027\u5927\u8178\u708e<\/td><td>\u9593\u8449\u7cfb\u5e79\u7d30\u80de\u6295\u4e0e<\/td><td>MSC\u6ce8\u8178\u7642\u6cd5\uff08\u81e8\u5e8a\u8a66\u9a13\u6bb5\u968e\uff09<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">7. \u5185\u5206\u6ccc\u5185\u79d1\u30fb\u7cd6\u5c3f\u75c5\u79d1<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u75be\u60a3\u540d<\/th><th>\u6cbb\u7642\u30a2\u30d7\u30ed\u30fc\u30c1<\/th><th>\u4e3b\u306a\u6cbb\u7642\u6cd5\u30fb\u88fd\u54c1\u540d<\/th><\/tr><\/thead><tbody><tr><td>1\u578b\u7cd6\u5c3f\u75c5<\/td><td>\u81b5\u5cf6\u7d30\u80de\u79fb\u690d \/ iPS\u7531\u6765\u03b2\u7d30\u80de\u79fb\u690d<\/td><td>\u30a8\u30c9\u30e2\u30f3\u30c8\u30f3\u30d7\u30ed\u30c8\u30b3\u30eb\uff08\u81b5\u5cf6\u79fb\u690d\uff09\u3001Viacyte VX-880\uff08\u81e8\u5e8a\u8a66\u9a13\uff09<\/td><\/tr><tr><td>\u7cd6\u5c3f\u75c5\u6027\u672b\u68a2\u795e\u7d4c\u969c\u5bb3<\/td><td>PRP\u30fb\u5e79\u7d30\u80de\u7642\u6cd5\uff08\u795e\u7d4c\u518d\u751f\uff09<\/td><td>PRP\u795e\u7d4c\u518d\u751f\u7642\u6cd5<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">8. \u773c\u79d1<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u75be\u60a3\u540d<\/th><th>\u6cbb\u7642\u30a2\u30d7\u30ed\u30fc\u30c1<\/th><th>\u4e3b\u306a\u6cbb\u7642\u6cd5\u30fb\u88fd\u54c1\u540d<\/th><\/tr><\/thead><tbody><tr><td>\u52a0\u9f62\u9ec4\u6591\u5909\u6027\uff08\u6ef2\u51fa\u578b\u30fb\u840e\u7e2e\u578b\uff09<\/td><td>iPS\/ES\u7531\u6765RPE\u7d30\u80de\u79fb\u690d<\/td><td>\u4f4f\u53cb\u30d5\u30a1\u30fc\u30deiPS-RPE\u3001RIKEN\u795e\u6238\u81e8\u5e8a\u7814\u7a76<\/td><\/tr><tr><td>\u89d2\u819c\u75be\u60a3\u30fb\u89d2\u819c\u5185\u76ae\u4e0d\u5168<\/td><td>\u81ea\u5bb6\u57f9\u990a\u89d2\u819c\u4e0a\u76ae\u79fb\u690d \/ \u89d2\u819c\u5185\u76ae\u7d30\u80de\u79fb\u690d<\/td><td>\u30cd\u30aa\u30b3\u30fc\u30cd\u30a2\u00ae\uff08J-TEC\uff09\u3001\u30cd\u30d4\u30c3\u30af\u00ae\u3001\u30aa\u30ad\u30e5\u30e9\u30eb\u00ae\u3001\u30b5\u30af\u30e9\u30b7\u30fc\u00ae\u3001\u30d3\u30ba\u30ce\u30d0\u00ae<\/td><\/tr><tr><td>\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7<\/td><td>\u5e79\u7d30\u80de\u7531\u6765\u5149\u53d7\u5bb9\u4f53\u79fb\u690d\uff08\u81e8\u5e8a\u8a66\u9a13\uff09<\/td><td>Lineage Cell Therapeutics OPC1<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">9. \u6ccc\u5c3f\u5668\u79d1\u30fb\u7523\u5a66\u4eba\u79d1<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u75be\u60a3\u540d<\/th><th>\u6cbb\u7642\u30a2\u30d7\u30ed\u30fc\u30c1<\/th><th>\u4e3b\u306a\u6cbb\u7642\u6cd5\u30fb\u88fd\u54c1\u540d<\/th><\/tr><\/thead><tbody><tr><td>\u8179\u5727\u6027\u5c3f\u5931\u7981<\/td><td>\u81ea\u5bb6\u7b4b\u82bd\u7d30\u80de\u6ce8\u5c04<\/td><td>\u7b4b\u82bd\u7d30\u80de\u5916\u62ec\u7d04\u7b4b\u6ce8\u5c04\uff08\u81e8\u5e8a\u7814\u7a76\uff09<\/td><\/tr><tr><td>\u52c3\u8d77\u969c\u5bb3\uff08ED\uff09<\/td><td>PRP\u30fb\u5e79\u7d30\u80de\u9670\u830e\u5185\u6ce8\u5c04<\/td><td>P-Shot\u00ae\uff08PRP\uff09<\/td><\/tr><tr><td>\u65e9\u671f\u5375\u5de3\u4e0d\u5168\uff08POI\uff09<\/td><td>PRP\u5375\u5de3\u5185\u6ce8\u5c04<\/td><td>Ovarian PRP\u7642\u6cd5<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">10. \u547c\u5438\u5668\u5185\u79d1<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u75be\u60a3\u540d<\/th><th>\u6cbb\u7642\u30a2\u30d7\u30ed\u30fc\u30c1<\/th><th>\u4e3b\u306a\u6cbb\u7642\u6cd5\u30fb\u88fd\u54c1\u540d<\/th><\/tr><\/thead><tbody><tr><td>\u6162\u6027\u9589\u585e\u6027\u80ba\u75be\u60a3\uff08COPD\uff09<\/td><td>\u9593\u8449\u7cfb\u5e79\u7d30\u80de\u9759\u8108\u5185\u6295\u4e0e<\/td><td>Prochymal\uff08\u81e8\u5e8a\u8a66\u9a13\uff09<\/td><\/tr><tr><td>\u6025\u6027\u547c\u5438\u7aae\u8feb\u75c7\u5019\u7fa4\uff08ARDS\uff09<\/td><td>MSC\u6295\u4e0e<\/td><td>MUST\u8a66\u9a13\u3001MARS\u8a66\u9a13<\/td><\/tr><tr><td>\u6c17\u7ba1\u30fb\u6c17\u7ba1\u652f\u518d\u5efa<\/td><td>\u8131\u7d30\u80de\u5316\u6c17\u7ba1\u30b9\u30ad\u30e3\u30d5\u30a9\u30fc\u30eb\u30c9\uff0b\u5e79\u7d30\u80de<\/td><td>Macchiarini\u6cd5\uff08\u5b9f\u9a13\u7684\uff09<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>\u88dc\u8db3\u30fb\u51e1\u4f8b\uff1a<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4fdd\u967a\u9069\u7528\u30fb\u85ac\u4e8b\u627f\u8a8d\u6e08\u307f\u306e\u4ee3\u8868\u4f8b\uff1a\u30ad\u30e0\u30ea\u30a2\u00ae\u3001\u30b8\u30a7\u30a4\u30b9\u00ae\uff08J-TEC\uff09\u3001\u30cd\u30aa\u30b3\u30fc\u30cd\u30a2\u00ae\uff08J-TEC\uff09\u3001\u30ea\u30cf\u30fc\u30c8\u00ae\uff08Cuorips\u793e\uff09\u3001\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u00ae\uff08\u4f4f\u53cb\u30d5\u30a1\u30fc\u30de\uff09\u3001Alofisel\u00ae<\/li>\n\n\n\n<li>\u7b2c\u4e00\u7a2e\u518d\u751f\u533b\u7642\u7b49\uff08\u7279\u5b9a\u7d30\u80de\u52a0\u5de5\u7269\uff09\uff1aES\/iPS\u7531\u6765\u7d30\u80de\u88fd\u54c1\u3001CAR-T\u7d30\u80de\u7642\u6cd5\u306a\u3069<\/li>\n\n\n\n<li>\u7b2c\u4e8c\u7a2e\u518d\u751f\u533b\u7642\u7b49\uff08\u81ea\u7531\u8a3a\u7642\u3067\u63d0\u4f9b\u53ef\u80fd\uff09\uff1aPRP\u7642\u6cd5\u3001\u8102\u80aa\u7531\u6765\u5e79\u7d30\u80de\uff08ADSC\uff09\u3001\u9aa8\u9ac4\u7531\u6765MSC\u306a\u3069<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a66\u9a13\u6bb5\u968e\u306e\u3082\u306e\u306f\u63d0\u4f9b\u6642\u306b\u539a\u751f\u52b4\u50cd\u7701\u3078\u306e\u8a08\u753b\u5c4a\u51fa\u307e\u305f\u306f\u627f\u8a8d\u304c\u5fc5\u8981<\/li>\n\n\n\n<li>\u672c\u8cc7\u6599\u306f2026\u5e743\u6708\u6642\u70b9\u306e\u60c5\u5831\u306b\u57fa\u3065\u304f\u3002\u9069\u5fdc\u30fb\u627f\u8a8d\u72b6\u6cc1\u306f\u968f\u6642\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3002<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u25a0 \u5f15\u7528\u30fb\u51fa\u5178\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u6570\u5024\u306e\u6271\u3044\u65b9<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">\u30c7\u30fc\u30bf\u7a2e\u5225\u5225 \u63a8\u5968\u4e00\u6b21\u60c5\u5831\u6e90<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30c7\u30fc\u30bf\u7a2e\u5225<\/th><th>\u63a8\u5968\u4e00\u6b21\u60c5\u5831\u6e90<\/th><th>\u6ce8\u610f\u4e8b\u9805<\/th><\/tr><\/thead><tbody><tr><td>FDA\u627f\u8a8d\u88fd\u54c1\u6570<\/td><td>FDA\u516c\u5f0f\u300cApproved Cellular and Gene Therapy Products\u300d\u4e00\u89a7<\/td><td>&#8220;Content current as of&#8221;\u306e\u65e5\u4ed8\u3092\u5fc5\u305a\u4f75\u8a18<\/td><\/tr><tr><td>RMAT\u6307\u5b9a\u7d71\u8a08<\/td><td>FDA CBER\u306e\u5e74\u6b21\u30c7\u30fc\u30bf\u30c6\u30fc\u30d6\u30eb\uff08&#8221;Data as of September 30, XXXX&#8221;\uff09<\/td><td>FY\uff08\u4f1a\u8a08\u5e74\u5ea6\uff09\u306e\u7bc4\u56f2\u3092\u660e\u793a<\/td><\/tr><tr><td>EU ATMP\u627f\u8a8d\u6570<\/td><td>EMA\u516c\u5f0fEPAR\u3001\u307e\u305f\u306fFrontiers in Medicine\u7b49\u306e\u5b66\u8853\u8ad6\u6587<\/td><td>\u96c6\u8a08\u6642\u70b9\uff08as of\uff09\u3092\u660e\u8a18<\/td><\/tr><tr><td>MSC\u81e8\u5e8a\u8a66\u9a13\u4ef6\u6570<\/td><td>ClinicalTrials.gov\u306e\u691c\u7d22\u3092\u5831\u544a\u3057\u305f\u67fb\u8aad\u8ad6\u6587\uff08Lu et al. 2025\u7b49\uff09<\/td><td>\u691c\u7d22\u5f0f\u30fb\u91cd\u8907\u9664\u53bb\u306e\u6709\u7121\u3092\u660e\u793a<\/td><\/tr><tr><td>hPSC\u81e8\u5e8a\u8a66\u9a13\u6570<\/td><td>Kirkeby et al. 2025, Cell Stem Cell\uff08as of Dec 2024\uff09<\/td><td>\u8ad6\u6587\u306e\u96c6\u8a08\u5b9a\u7fa9\u3092\u7d99\u627f<\/td><\/tr><tr><td>\u5e02\u5834\u898f\u6a21<\/td><td>Fortune Business Insights\u7b49\u306e\u8abf\u67fb\u4f1a\u793e<\/td><td>\u300c\u3007\u3007\u793e\u63a8\u8a08\u3067\u306f\u300d\u3068\u51fa\u5178\u3092\u660e\u793a<\/td><\/tr><tr><td>\u65e5\u672c\u627f\u8a8d\u88fd\u54c1\u6570<\/td><td>PMDA\u516c\u5f0f\u627f\u8a8d\u60c5\u5831\u3001\u539a\u751f\u52b4\u50cd\u7701\u901a\u77e5<\/td><td>\u6761\u4ef6\u4ed8\u304d\/\u6b63\u5f0f\u627f\u8a8d\u306e\u5225\u3092\u660e\u8a18<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">\u30d5\u30a1\u30af\u30c8\u30c1\u30a7\u30c3\u30af\u6e08\u307f\u6570\u5024\u306e\u78ba\u5b9a\u5024\uff082026\u5e743\u670830\u65e5\u6642\u70b9\uff09<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u4e3b\u5f35<\/th><th>\u78ba\u8a8d\u7d50\u679c<\/th><th>\u6b63\u78ba\u306a\u6570\u5024\u30fb\u8868\u73fe<\/th><th>\u51fa\u5178<\/th><\/tr><\/thead><tbody><tr><td>2026\u5e743\u6708iPS\u7d30\u80de\u7531\u6765\u88fd\u54c1\u627f\u8a8d<\/td><td><strong>\u6b63\u78ba<\/strong><\/td><td>2026\u5e743\u67086\u65e5\u30012\u54c1\u76ee\u304c\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d<\/td><td>\u539a\u52b4\u7701\u901a\u77e5\u30fbPMDA\u8cc7\u6599<\/td><\/tr><tr><td>\u300c\u4e16\u754c\u521d\u627f\u8a8d\u300d<\/td><td><strong>\u4e00\u90e8\u6b63\u78ba<\/strong><\/td><td>\u300c\u4e16\u754c\u521d\u306eiPSC\u7531\u6765\u6cbb\u7642\u88fd\u54c1\u306e\u898f\u5236\u5f53\u5c40\u627f\u8a8d\u3068\u3057\u3066\u5831\u3058\u3089\u308c\u3066\u3044\u308b\uff08\u51fa\u5178\uff1aAABB\u7b49\uff09\u300d<\/td><td>AABB\u3001Science Portal\u7b49<\/td><\/tr><tr><td>\u5b89\u78ba\u6cd5\u65bd\u884c\u65e5<\/td><td><strong>\u6b63\u78ba<\/strong><\/td><td>2014\u5e7411\u670825\u65e5\u65bd\u884c<\/td><td>\u539a\u52b4\u7701\u6574\u7406\u30da\u30fc\u30b8<\/td><\/tr><tr><td>\u5b89\u78ba\u6cd5\u6539\u6b63\u65bd\u884c\u65e5<\/td><td><strong>\u6b63\u78ba<\/strong><\/td><td>2025\u5e745\u670831\u65e5\u65bd\u884c<\/td><td>\u539a\u52b4\u7701\u6574\u7406\u30da\u30fc\u30b8<\/td><\/tr><tr><td>FDA CGT\u627f\u8a8d\u88fd\u54c1\u6570<\/td><td><strong>\u4fee\u6b63\u6e08\u307f<\/strong>\uff0847\u219248\uff09<\/td><td>48\u88fd\u54c1\uff082025\u5e7412\u67089\u65e5\u73fe\u5728\uff09<\/td><td>FDA\u516c\u5f0f\u4e00\u89a7<\/td><\/tr><tr><td>RMAT\u6307\u5b9a\u4ef6\u6570<\/td><td><strong>\u4fee\u6b63\u6e08\u307f<\/strong>\uff08105\u2192193\uff09<\/td><td>\u7533\u8acb388\u4ef6\u30fb\u8a8d\u5b9a193\u4ef6\uff08FY2017-2025\uff09<\/td><td>FDA CBER\u516c\u5f0f<\/td><\/tr><tr><td>EU CAR-T\u627f\u8a8d\u6570<\/td><td><strong>\u4fee\u6b63\u6e08\u307f<\/strong>\uff0815\u88fd\u54c1\u21926\u88fd\u54c1\u30fb15\u9069\u5fdc\uff09<\/td><td>6\u88fd\u54c1\u30fb15\u9069\u5fdc\uff082025\u5e744\u6708\u6642\u70b9\uff09<\/td><td>\u5b66\u8853\u8ad6\u6587<\/td><\/tr><tr><td>hPSC\u81e8\u5e8a\u8a66\u9a13\u6570<\/td><td><strong>\u6b63\u78ba<\/strong><\/td><td>115\u8a66\u9a13\u30fb83\u88fd\u54c1\u30fb1,200\u4eba\u4ee5\u4e0a\uff08as of Dec 2024\uff09<\/td><td>Cell Stem Cell 2025<\/td><\/tr><tr><td>\u30cf\u30fc\u30c8\u30b7\u30fc\u30c8\u627f\u8a8d\u53d6\u6d88<\/td><td><strong>\u4e00\u90e8\u6b63\u78ba<\/strong><\/td><td>\u300c\u672c\u627f\u8a8d\u306f\u4e0d\u627f\u8a8d\u3068\u306a\u308a\u6761\u4ef6\u53ca\u3073\u671f\u9650\u4ed8\u627f\u8a8d\u306f\u5931\u52b9\u300d\uff08&#8221;\u627f\u8a8d\u53d6\u6d88&#8221;\u306f\u4e0d\u6b63\u78ba\uff09<\/td><td>PMDA\u5be9\u8b70\u7d50\u679c<\/td><\/tr><tr><td>\u30b3\u30e9\u30c6\u30b8\u30a7\u30f3\u627f\u8a8d\u5931\u52b9<\/td><td><strong>\u6b63\u78ba<\/strong><\/td><td>2024\u5e746\u6708\u7533\u8acb\u53d6\u4e0b\u3052\u306b\u3088\u308a\u627f\u8a8d\u5931\u52b9<\/td><td>\u7530\u8fba\u30d5\u30a1\u30fc\u30de\u767a\u8868<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u25a0 \u5168\u5f15\u7528\u6587\u732e\u30fbURL\u4e00\u89a7<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">\u65e5\u672c\u306e\u898f\u5236\u30fb\u516c\u7684\u6a5f\u95a2<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u518d\u751f\u533b\u7642\u7b49\u5b89\u5168\u6027\u78ba\u4fdd\u6cd5<\/strong>\uff08\u5e73\u621025\u5e74\u6cd5\u5f8b\u7b2c85\u53f7\uff09<\/li>\n\n\n\n<li>URL: https:\/\/laws.e-gov.go.jp\/law\/425AC0000000085<\/li>\n\n\n\n<li>URL: https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000150542_00016.html<\/li>\n\n\n\n<li><strong>\u5b89\u78ba\u6cd5\u6539\u6b63\u6cd5<\/strong>\uff08\u4ee4\u548c6\u5e74\u6cd5\u5f8b\u7b2c51\u53f7\uff09<\/li>\n\n\n\n<li>\u516c\u5e03\uff1a2024\u5e746\u670814\u65e5\u3001\u65bd\u884c\uff1a2025\u5e745\u670831\u65e5<\/li>\n\n\n\n<li>URL: https:\/\/www.mhlw.go.jp\/content\/001265334.pdf<\/li>\n\n\n\n<li><strong>\u6539\u6b63\u5b89\u78ba\u6cd5Q&amp;A<\/strong>\uff08\u4ee4\u548c7\u5e745\u670830\u65e5\u4ed8\uff09<\/li>\n\n\n\n<li>URL: https:\/\/www.mhlw.go.jp\/content\/10800000\/001498987.pdf<\/li>\n\n\n\n<li><strong>\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u306e\u627f\u8a8d\u30ea\u30b9\u30c8\uff08PMDA\uff09<\/strong><\/li>\n\n\n\n<li>URL: https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/review-information\/ctp\/0004.html<\/li>\n\n\n\n<li><strong>\u30cf\u30fc\u30c8\u30b7\u30fc\u30c8\uff08\u30c6\u30eb\u30e2\uff09\u5be9\u8b70\u7d50\u679c\u5831\u544a\u66f8<\/strong>\uff082024\u5e747\u670824\u65e5\u5be9\u8b70\uff09<\/li>\n\n\n\n<li>URL: https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/review-information\/ctp\/0004.html<\/li>\n\n\n\n<li><strong>\u30b3\u30e9\u30c6\u30b8\u30a7\u30f3 \u7533\u8acb\u53d6\u4e0b\u3052\u767a\u8868<\/strong>\uff08\u7530\u8fba\u30d5\u30a1\u30fc\u30de\u30012024\u5e746\u670824\u65e5\uff09<\/li>\n\n\n\n<li>URL: https:\/\/www.tanabe-pharma.com\/ja\/news\/MTPC240624.html<\/li>\n\n\n\n<li><strong>\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u30fb\u30ea\u30cf\u30fc\u30c8 2026\u5e743\u67086\u65e5\u627f\u8a8d<\/strong>\uff08PMDA\u30fb\u4f4f\u53cb\u30d5\u30a1\u30fc\u30de\uff09<\/li>\n\n\n\n<li>URL\uff08\u4f4f\u53cb\u30d5\u30a1\u30fc\u30de\u767a\u8868\uff09: https:\/\/www.sumitomo-pharma.co.jp\/news\/20260213.html<\/li>\n\n\n\n<li>URL\uff08PMDA\uff09: https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/review-information\/ctp\/0002.html<\/li>\n\n\n\n<li><strong>\u65e5\u672c\u533b\u5e2b\u4f1a\u89e3\u8aac<\/strong>\uff08\u518d\u751f\u533b\u7642\u7b49\u5b89\u5168\u6027\u78ba\u4fdd\u6cd5\u306e\u7d71\u8a08\uff09<\/li>\n\n\n\n<li>URL: https:\/\/www.med.or.jp\/doctor\/rinri\/i_rinri\/h06.html<\/li>\n\n\n\n<li><strong>GCTP\u7701\u4ee4<\/strong>\uff08\u5e73\u621026\u5e74\u539a\u751f\u52b4\u50cd\u7701\u4ee4\u7b2c93\u53f7\uff09<\/li>\n\n\n\n<li>URL: https:\/\/laws.e-gov.go.jp\/law\/426M60000100093<\/li>\n\n\n\n<li><strong>eCTD v4.0\uff08PMDA\uff09<\/strong>\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.pmda.go.jp\/int-activities\/int-harmony\/ich\/0037.html<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u518d\u751f\u533b\u7642\u63a8\u9032\u6cd5<\/strong>\uff08\u5e73\u621025\u5e74\u6cd5\u5f8b\u7b2c13\u53f7\uff09\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/hourei.ndl.go.jp\/simple\/detail?lawId=0000129358&amp;current=1<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">FDA\u30fb\u7c73\u56fd\u95a2\u9023<\/h3>\n\n\n\n<ol start=\"12\" class=\"wp-block-list\">\n<li><strong>FDA Approved Cellular and Gene Therapy Products<\/strong>\uff08Content current as of 12\/09\/2025\uff09\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/approved-cellular-and-gene-therapy-products<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>FDA CBER RMAT Designation Requests<\/strong>\uff08Data as of September 30, 2025\uff09\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/cumulative-cber-regenerative-medicine-advanced-therapy-rmat-designation-requests-received-fiscal<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>FDA OTP\u8a2d\u7acb<\/strong>\uff082023\u5e742\u670826\u65e5\uff09\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/establishment-office-therapeutic-products<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>FDA 2025\u5e749\u6708\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9<\/strong>\uff08Expedited Programs for Regenerative Medicine Therapies\uff09\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.fda.gov\/media\/188874\/download<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Casgevy FDA\u627f\u8a8d<\/strong>\uff082023\u5e7412\u67088\u65e5\uff09\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Ryoncil FDA\u627f\u8a8d<\/strong>\uff082024\u5e7412\u670818\u65e5\uff09\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">EMA\u30fbEU\u95a2\u9023<\/h3>\n\n\n\n<ol start=\"18\" class=\"wp-block-list\">\n<li><strong>EU ATMP\u898f\u5236<\/strong>\uff08Regulation EC No 1394\/2007\uff09\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/eur-lex.europa.eu\/eli\/reg\/2007\/1394\/oj\/eng<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Alofisel EU\u64a4\u9000<\/strong>\uff082024\u5e7412\u6708\uff09\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/alofisel<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Zynteglo EU\u64a4\u9000<\/strong>\uff082022\u5e74\uff09\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/zynteglo<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">\u5b66\u8853\u8ad6\u6587<\/h3>\n\n\n\n<ol start=\"21\" class=\"wp-block-list\">\n<li><strong>Kirkeby A, et al.<\/strong> Pluripotent stem-cell-derived therapies in clinical trial: A 2025 update. <em>Cell Stem Cell<\/em>. 2025;32(1):10-37.\n<ul class=\"wp-block-list\">\n<li>DOI: 10.1016\/j.stem.2024.12.005<\/li>\n\n\n\n<li>URL: https:\/\/www.cell.com\/cell-stem-cell\/fulltext\/S1934-5909(24)00445-4<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Lu W, Allickson J.<\/strong> Mesenchymal stromal cell therapy: Progress to date and future outlook. <em>Mol Ther<\/em>. 2025;33(6):2679-2688.\n<ul class=\"wp-block-list\">\n<li>DOI: 10.1016\/j.ymthe.2025.02.003<\/li>\n\n\n\n<li>URL: https:\/\/pubmed.ncbi.nlm.nih.gov\/39916329\/<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Shan Y, et al.<\/strong> Pharmacokinetic characteristics of mesenchymal stem cells in translational challenges. <em>Signal Transduct Target Ther<\/em>. 2024.\n<ul class=\"wp-block-list\">\n<li>DOI: 10.1038\/s41392-024-01936-8<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Alaburde et al.<\/strong> Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency. <em>Frontiers in Medicine<\/em>. 2025;12.\n<ul class=\"wp-block-list\">\n<li>DOI: 10.3389\/fmed.2025.1623689<\/li>\n\n\n\n<li>URL: https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC12240929\/<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Anzalone AV, et al.<\/strong> Search-and-replace genome editing without double-strand breaks or donor DNA. <em>Nature<\/em>. 2019;576:149-157.\n<ul class=\"wp-block-list\">\n<li>DOI: 10.1038\/s41586-019-1711-4<\/li>\n\n\n\n<li>URL: https:\/\/www.nature.com\/articles\/s41586-019-1711-4<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Fern\u00e1ndez-Garza LE, et al.<\/strong> Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World. <em>Pharmaceuticals<\/em>. 2023;16(9):1334.\n<ul class=\"wp-block-list\">\n<li>DOI: 10.3390\/ph16091334<\/li>\n\n\n\n<li>URL: https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC10536665\/<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">\u305d\u306e\u4ed6<\/h3>\n\n\n\n<ol start=\"27\" class=\"wp-block-list\">\n<li><strong>AABB\u8a18\u4e8b<\/strong>\uff082026\u5e742\u670824\u65e5\uff09Japanese Regulatory Panel Recommends Advancing World&#8217;s First iPSC-Based Therapies.\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.aabb.org\/news-resources\/news\/article\/2026\/02\/24\/japanese-regulatory-panel-recommends-advancing-world-s-first-ipsc-based-therapies<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>CiRA iPS\u7d30\u80de\u30b9\u30c8\u30c3\u30af\u4e8b\u696d<\/strong>\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.cira.kyoto-u.ac.jp\/e\/research\/stock.html<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Fortune Business Insights<\/strong> \u518d\u751f\u533b\u7642\u5e02\u5834\u30ec\u30dd\u30fc\u30c8\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.fortunebusinessinsights.com\/industry-reports\/regenerative-medicine-market-100970<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>ISSCR 2021\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/strong>\uff082025\u5e74SCBEM\u66f4\u65b0\uff09\n<ul class=\"wp-block-list\">\n<li>URL: https:\/\/www.isscr.org\/guidelines<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator 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