{"id":581,"date":"2026-07-23T13:25:00","date_gmt":"2026-07-23T04:25:00","guid":{"rendered":"https:\/\/rmnw.jp\/teams\/?p=581"},"modified":"2026-07-23T13:28:44","modified_gmt":"2026-07-23T04:28:44","slug":"2026-07-23%e5%86%8d%e7%94%9f%e5%8c%bb%e7%99%82-%e5%8c%bb%e5%b8%ab%e5%90%91%e3%81%91%e6%95%99%e7%a7%91%e6%9b%b8-%e7%ab%a0%e7%ab%8b%e3%81%a6%e3%82%ae%e3%83%a3%e3%83%83%e3%83%97%e5%88%86%e6%9e%90","status":"publish","type":"post","link":"https:\/\/rmnw.jp\/teams\/?p=581","title":{"rendered":"2026-07-23\u518d\u751f\u533b\u7642 \u533b\u5e2b\u5411\u3051\u6559\u79d1\u66f8 \u7ae0\u7acb\u3066\u30ae\u30e3\u30c3\u30d7\u5206\u6790"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">TL;DR<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u65e2\u5b5830\u7ae0\u306f\u300c\u57fa\u790e\u79d1\u5b66\u2192\u65e5\u672c\u898f\u5236\u2192\u56fd\u969b\u898f\u5236\u2192\u8a3a\u7642\u79d1\u5225\u81e8\u5e8a\u2192\u502b\u7406\u30fb\u793e\u4f1a\u5b9f\u88c5\u2192\u5148\u7aef\u6280\u8853\u300d\u3068\u3044\u3046\u9aa8\u683c\u3068\u3057\u3066\u5b8c\u6210\u5ea6\u304c\u9ad8\u3044\u304c\u3001\u7d4c\u55b6\u5c64\u8aad\u8005\u306b\u3068\u3063\u3066\u6700\u91cd\u8981\u306e\u300c\u2460\u7d30\u80de\u88fd\u9020\u30fbCMC\u30fb\u54c1\u8cea\u5206\u6790\u306e\u5b9f\u52d9\u300d\u300c\u2461\u4fdd\u967a\u511f\u9084\u30fb\u533b\u7642\u6a5f\u95a2\u7d4c\u55b6\u30fb\u610f\u601d\u6c7a\u5b9a\u300d\u300c\u2462\u514d\u75ab\u5b66\uff08\u540c\u7a2e\u79fb\u690d\u30fbHLA\u30fbuniversal donor\uff09\u300d\u306e3\u9818\u57df\u304c\u72ec\u7acb\u7ae0\u3068\u3057\u3066\u6c7a\u5b9a\u7684\u306b\u6b20\u843d\u3057\u3066\u304a\u308a\u3001\u6700\u512a\u5148\u3067\u65b0\u8a2d\u3059\u3079\u304d\u3067\u3042\u308b\u3002<\/li>\n\n\n\n<li>iPS\u7d30\u80de\u7531\u6765\u88fd\u54c1\u306e\u5b9f\u7528\u5316\u6642\u4ee3\uff082026\u5e743\u67086\u65e5\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u30fb\u30ea\u30cf\u30fc\u30c8\u627f\u8a8d\u30015\u670820\u65e5\u85ac\u4fa1\u53ce\u8f09\uff09\u3068\u30012025\u5e745\u670831\u65e5\u65bd\u884c\u306e\u6539\u6b63\u5b89\u78ba\u6cd5\uff08in vivo\u907a\u4f1d\u5b50\u6cbb\u7642\u306e\u53d6\u308a\u8fbc\u307f\uff09\u3001\u57f9\u990a\u4e0a\u6e05\u30fb\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u306e\u30ea\u30b9\u30af\u5206\u985e\u898b\u76f4\u3057\u8b70\u8ad6\uff082025\u5e746\u6708\u5831\u544a\uff09\u306f\u3001\u65e2\u5b58\u69cb\u6210\u304c\u53cd\u6620\u3057\u304d\u308c\u3066\u3044\u306a\u3044\u6700\u65b0\u306e\u5fc5\u9808\u30c8\u30d4\u30c3\u30af\u3067\u3042\u308a\u3001\u898f\u5236\u7ae0\u30fb\u502b\u7406\u7ae0\u30fb\u7d4c\u55b6\u7ae0\u306b\u307e\u305f\u304c\u308b\u518d\u7de8\u304c\u6025\u52d9\u3002<\/li>\n\n\n\n<li>\u8a3a\u7642\u79d1\u3067\u306f\u8033\u9f3b\u54bd\u5589\u79d1\u30fb\u814e\u81d3\u5185\u79d1\uff08\u900f\u6790\/CKD\uff09\u30fb\u30ea\u30cf\u30d3\u30ea\u30fb\u75bc\u75db\u30fb\u751f\u6b96\u533b\u7642\u30fb\u7dda\u7dad\u75c7\/\u8001\u5316\u306a\u3069\u304c\u624b\u8584\u3002\u72ec\u7acb\u65b0\u8a2d\u3092\u63a8\u5968\u3059\u308b\u306e\u306f\u300c\u7d30\u80de\u88fd\u9020\u30fbCMC\u300d\u300c\u514d\u75ab\u5b66\u300d\u300c\u4fdd\u967a\u511f\u9084\u30fb\u533b\u7642\u7d4c\u6e08\u300d\u300c\u533b\u7642\u6a5f\u95a2\u7d4c\u55b6\u30fb\u90e8\u9580\u904b\u55b6\u300d\u300c\u30a2\u30b8\u30a2\/\u305d\u306e\u4ed6\u56fd\u969b\u898f\u5236\u300d\u300c\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u30fb\u57f9\u990a\u4e0a\u6e05\u306e\u898f\u5236\u3068\u54c1\u8cea\u300d\u306e6\u7ae0\u76f8\u5f53\u3002\u51686\u90e830\u7ae0\u2192\u51688\u90e840\u7ae0\u7a0b\u5ea6\u3078\u306e\u62e1\u5f35\u304c\u59a5\u5f53\u3067\u3042\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Key Findings<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. \u69cb\u6210\u4e0a\u306e\u6839\u672c\u7684\u6b20\u843d\uff08\u72ec\u7acb\u7ae0\u30fb\u72ec\u7acb\u90e8\u30ec\u30d9\u30eb\uff09<\/strong> \u65e2\u5b58\u69cb\u6210\u306f\u81e8\u5e8a\u5fdc\u7528\uff08\u7b2c\u2163\u90e88\u7ae0\uff09\u3068\u898f\u5236\uff08\u7b2c\u2161\u30fb\u2162\u90e8\uff09\u306b\u539a\u3044\u4e00\u65b9\u3001Atala\/Lanza\u300ePrinciples of Regenerative Medicine\u300f3rd\uff082019\u3001Elsevier\uff09\u304cPart III\u5168\u4f53\u3092\u300cBiomaterials for Regenerative Medicine\u300d\u3001Part IV\u3092\u300cTherapeutic Applications\uff08Cell Therapy \/ Tissue Therapy\uff09\u300d\u306b\u5145\u3066\u3066\u3044\u308b\u306e\u306b\u5bfe\u3057\u3001\u307e\u305f\u65e5\u672c\u518d\u751f\u533b\u7642\u5b66\u4f1a\u300e\u30c6\u30ad\u30b9\u30c8\u30d6\u30c3\u30af\u518d\u751f\u533b\u7642\u301c\u5275\u308b\u3001\u884c\u3046\u3001\u652f\u3048\u308b\u301c\u300f\uff082019\/2021\u3001720\u9801\uff09\u304c\u7b2c3\u90e8\u5168\u4f53\u3092\u300c\u7d30\u80de\u306e\u52a0\u5de5\u30fb\u88fd\u9020\u300d\uff08\u65bd\u8a2d\u30fb\u69cb\u9020\u8a2d\u5099\uff0f\u88fd\u9020\u7ba1\u7406\uff0f\u885b\u751f\u7ba1\u7406\uff0f\u54c1\u8cea\u7ba1\u7406\uff0f\u4f5c\u696d\u306e\u5b9f\u969b\u306e5\u7ae0\uff09\u306b\u5145\u3066\u3066\u3044\u308b\u306e\u306b\u5bfe\u3057\u3001<strong>\u672c\u69cb\u6210\u306b\u306f\u88fd\u9020\u30fbCMC\u30fb\u54c1\u8cea\u5206\u6790\u3092\u4e3b\u984c\u5316\u3057\u305f\u300c\u90e8\u300d\u304c\u5b58\u5728\u3057\u306a\u3044<\/strong>\u70b9\u304c\u6700\u5927\u306e\u6b20\u843d\u3067\u3042\u308b\u3002\u65e2\u5b58\u306e\u7b2c10\u7ae0\uff08GCTP\/CPC\uff09\u30fb\u7b2c11\u7ae0\uff08\u54c1\u8cea\u4fdd\u8a3c\uff1a\u539f\u6750\u6599\u7ba1\u7406\u30fb\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\uff09\u306f\u65bd\u8a2d\u7ba1\u7406\u30fb\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u4e2d\u5fc3\u3067\u3042\u308a\u3001\u5de5\u7a0b\u958b\u767a\u30fb\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\u30fb\u5206\u6790\u6cd5\u30fb\u52b9\u529b\u8a66\u9a13\u3068\u3044\u3063\u305f\u958b\u767a\u6280\u8853\u8ad6\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u306a\u3044\u3002Steinhoff\u300eRegenerative Medicine: From Protocol to Patient\u300f\uff08Springer\u30015\u5dfb\u672c\uff09\u3082Vol.3\u3092\u4e38\u3054\u3068\u300cTissue Engineering, Biomaterials and Nanotechnology\u300d\u306b\u5145\u3066\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. iPS\u6642\u4ee3\u30fb\u6700\u65b0\u898f\u5236\uff082024-2026\uff09\u306e\u53cd\u6620\u4e0d\u8db3<\/strong> 2026\u5e743\u67086\u65e5\u3001\u4f4f\u53cb\u30d5\u30a1\u30fc\u30de\u306e\u30d1\u30fc\u30ad\u30f3\u30bd\u30f3\u75c5\u6cbb\u7642iPS\u7531\u6765\u88fd\u54c1\u300c\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u300d\uff08\u4e00\u822c\u540d\u30e9\u30b0\u30cd\u30d7\u30ed\u30bb\u30eb\u3001\u975e\u81ea\u5df1iPS\u7d30\u80de\u7531\u6765\u30c9\u30d1\u30df\u30f3\u795e\u7d4c\u524d\u99c6\u7d30\u80de\uff09\u3068\u30af\u30aa\u30ea\u30d7\u30b9\u306e\u5fc3\u7b4b\u30b7\u30fc\u30c8\u300c\u30ea\u30cf\u30fc\u30c8\u300d\u304c\u3001iPS\u7d30\u80de\u7531\u6765\u306e\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u3068\u3057\u3066\u4e16\u754c\u3067\u521d\u3081\u3066\u6761\u4ef6\u30fb\u671f\u9650\u4ed8\u627f\u8a8d\uff08\u85ac\u6a5f\u6cd5\u7b2c23\u6761\u306e26\u3001\u627f\u8a8d\u304b\u30897\u5e74\u30012033\u5e743\u67085\u65e5\u307e\u3067\u306b\u518d\u7533\u8acb\uff09\u3092\u53d6\u5f97\u3057\u305f\u3002\u4e2d\u533b\u5354\u306f2026\u5e745\u670813\u65e5\u306b\u3053\u308c\u3089\u3092\u4e86\u627f\u3057\u30015\u670820\u65e5\u4ed8\u3067\u85ac\u4fa1\u57fa\u6e96\u53ce\u8f09\u30fb\u4fdd\u967a\u9069\u7528\u304c\u958b\u59cb\u3055\u308c\u305f\u3002\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u306e\u516c\u5b9a\u4fa1\u683c\u306f\u539f\u4fa1\u8a08\u7b97\u65b9\u5f0f\uff0b\u5e02\u5834\u6027\u52a0\u7b97I\uff0810%\uff09\uff0b\u5148\u99c6\u52a0\u7b97\uff0810%\uff09\u3067\u300c18\u74f61\u7d44 55,306,737\u5186\uff08\u7d045,530\u4e07\u5186\uff09\u300d\u3001\u30d4\u30fc\u30af\u6642\uff082035\u5e74\u5ea6\uff09\u6295\u4e0e\u60a3\u8005\u6570133\u4eba\u30fb\u8ca9\u58f2\u91d1\u984d74\u5104\u5186\u306e\u898b\u8fbc\u307f\u3002\u30b5\u30f3\u30d0\u30a4\u30aa\u306e\u5916\u50b7\u6027\u8133\u640d\u50b7\u5411\u3051\u300c\u30a2\u30af\u30fc\u30b4\u8133\u5185\u79fb\u690d\u7528\u6ce8\u300d\uff08\u4ed6\u5bb6\u9aa8\u9ac4\u7531\u6765\u52a0\u5de5\u9593\u8449\u7cfb\u5e79\u7d30\u80de\uff09\u306f1\u56de\u52067,271\u4e076,528\u5186\u3002\u6539\u6b63\u5b89\u78ba\u6cd5\u306f\u300c\u4ee4\u548c7\u5e74\uff082025\u5e74\uff095\u670831\u65e5\u65bd\u884c\u300d\uff08\u516c\u5e03\uff1a\u4ee4\u548c6\u5e746\u670814\u65e5\u3001\u65bd\u884c\u671f\u65e5\u653f\u4ee4\uff1a\u4ee4\u548c6\u5e7412\u67086\u65e5\uff09\u3067\u3001\u7d30\u80de\u52a0\u5de5\u7269\u3092\u7528\u3044\u306a\u3044in vivo\u907a\u4f1d\u5b50\u6cbb\u7642\u7b49\u3092\u7b2c\u4e00\u7a2e\u518d\u751f\u533b\u7642\u7b49\u6280\u8853\u3068\u3057\u3066\u65b0\u305f\u306b\u898f\u5236\u5bfe\u8c61\u5316\u3057\u3001\u8a8d\u5b9a\u518d\u751f\u533b\u7642\u7b49\u59d4\u54e1\u4f1a\u3078\u306e\u7acb\u5165\u691c\u67fb\u898f\u5b9a\u3082\u6574\u5099\u3055\u308c\u305f\u3002\u3053\u308c\u3089\u306f\u65e2\u5b58\u7ae0\u3078\u306e\u6563\u5728\u7684\u52a0\u7b46\u3067\u306f\u4e0d\u5341\u5206\u3067\u3001\u898f\u5236\u30fb\u7d4c\u55b6\u30fb\u502b\u7406\u306e\u8907\u6570\u7ae0\u306e\u518d\u7de8\u3092\u8981\u3059\u308b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. \u7d4c\u55b6\u5c64\u8aad\u8005\u5411\u3051\u8996\u70b9\u306e\u7cfb\u7d71\u7684\u6b20\u843d<\/strong> \u5bfe\u8c61\u8aad\u8005\u304c\u533b\u7642\u6a5f\u95a2\u4ee3\u8868\u7406\u4e8b\u3067\u3042\u308b\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u4fdd\u967a\u511f\u9084\u30fb\u85ac\u4fa1\u7b97\u5b9a\u3001\u90e8\u9580\u7acb\u3061\u4e0a\u3052\u30fb\u63a1\u7b97\u6027\u3001\u6709\u5bb3\u4e8b\u8c61\u5bfe\u5fdc\u5b9f\u52d9\u3001\u30ec\u30b8\u30b9\u30c8\u30ea\u30fbRWD\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3068\u3044\u3063\u305f\u7d4c\u55b6\u5224\u65ad\u306b\u76f4\u7d50\u3059\u308b\u9805\u76ee\u304c\u72ec\u7acb\u7ae0\u3068\u3057\u3066\u5b58\u5728\u3057\u306a\u3044\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Details<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">A. \u72ec\u7acb\u3057\u305f\u7ae0\u30fb\u7bc0\u3092\u65b0\u8a2d\u3059\u3079\u304d\u9805\u76ee\uff08\u512a\u5148\u5ea6\u4ed8\u304d\uff09<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u3010\u6700\u512a\u5148\u30fb\u72ec\u7acb\u90e8\u5019\u88dc\u3011\u7b2c\u2166\u90e8\u300c\u7d30\u80de\u88fd\u9020\u30fbCMC\u30fb\u54c1\u8cea\u5206\u6790\u300d\uff08\u65b0\u8a2d\u30014\u7ae0\uff09<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>\u306a\u305c\u5fc5\u8981\u304b<\/em>\uff1a\u4ee3\u8868\u7406\u4e8b\u306f\u81ea\u9662CPC\u6295\u8cc7\u30fbCDMO\u59d4\u8a17\u30fb\u5546\u7528\u88fd\u9020\u79fb\u884c\u306e\u610f\u601d\u6c7a\u5b9a\u3092\u62c5\u3046\u3002\u5de5\u7a0b\u958b\u767a\u3001\u96c6\u4e2d\u88fd\u9020 vs \u5206\u6563\u88fd\u9020\uff08point-of-care\uff09\u3001\u81ea\u52d5\u5316\u30fb\u30af\u30ed\u30fc\u30ba\u30c9\u30b7\u30b9\u30c6\u30e0\u3001\u30b3\u30b9\u30c8\u30fb\u30aa\u30d6\u30fb\u30b0\u30c3\u30ba\u306f\u63a1\u7b97\u6027\u5224\u65ad\u306e\u4e2d\u6838\u3002\u518d\u751f\u30fb\u7d30\u80de\u533b\u7642\u5206\u91ce\u306f\u300c\u5275\u85ac\u30d9\u30f3\u30c1\u30e3\u30fc\u304c\u521d\u671f\u958b\u767a\u3001\u88fd\u9020\u958b\u767a\u306fCDMO\u306b\u59d4\u8a17\u3059\u308b\u6c34\u5e73\u5206\u696d\u300d\u304c\u4e00\u822c\u7684\u3067\u3042\u308a\u3001\u7d4c\u55b6\u5224\u65ad\u3068\u3057\u3066\u3053\u306e\u69cb\u9020\u7406\u89e3\u304c\u4e0d\u53ef\u6b20\u3002<\/li>\n\n\n\n<li>\u65b0\u8a2d\u7ae0\u6848\uff1a(1) \u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u958b\u767a\u3068\u30b9\u30b1\u30fc\u30eb\u30a2\u30c3\u30d7\uff0f\u81ea\u52d5\u5316\u30fb\u30af\u30ed\u30fc\u30ba\u30c9\u30b7\u30b9\u30c6\u30e0\u3001(2) CDMO\/CMO\u6226\u7565\u3068\u6c34\u5e73\u5206\u696d\u3001(3) \u5206\u6790\u6cd5\u30fb\u7279\u6027\u89e3\u6790\uff08\u30d5\u30ed\u30fc\u30b5\u30a4\u30c8\u30e1\u30c8\u30ea\u30fc\u3001NGS\u3001\u52b9\u529b\u8a66\u9a13potency assay\u3001\u8fc5\u901f\u7121\u83cc\u8a66\u9a13\u3001CQA\/CPP\u8a2d\u5b9a\u3001comparability\uff09\u3001(4) \u51cd\u7d50\u4fdd\u5b58\u79d1\u5b66\u3068\u30b3\u30fc\u30eb\u30c9\u30c1\u30a7\u30fc\u30f3\u7269\u6d41\uff08DMSO\u4ee3\u66ff\u30fb\u30a2\u30f3\u30d3\u30a8\u30f3\u30c8\u8f38\u9001\u30fbchain of identity\/custody\uff09\u3002<\/li>\n\n\n\n<li>\u4e00\u6b21\u60c5\u5831\uff1aFDA &#8220;Potency Assurance for Cellular and Gene Therapy Products&#8221;\uff08Draft Guidance, 2023\u5e7412\u6708\uff09\u3001FDA &#8220;Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products&#8221;\uff08Draft Guidance, 2023\u5e747\u6708\uff09\u3001\u7d4c\u6e08\u7523\u696d\u7701\u30fb\u518d\u751f\u533b\u7642\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u30d5\u30a9\u30fc\u30e9\u30e0\uff08FIRM\uff09\u300c\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1CDMO\u4f01\u696d\u30ea\u30b9\u30c8\u300d\uff082025\u5e744\u67081\u65e5\u516c\u8868\u3001\u63b2\u8f0926\u793e\u3001\u8abf\u67fb\u6642\u671f2024\u5e7412\u6708\u301c2025\u5e742\u6708\uff09\u3001ISO 23033:2021\uff08Biotechnology\u2014\u7d30\u80de\u6cbb\u7642\u88fd\u54c1\u306e\u5206\u6790\u6cd5\u30fb\u7279\u6027\u89e3\u6790\uff09\u3001ISO\/AWI 21973\uff08\u7d30\u80de\u8f38\u9001\u306e\u8981\u4ef6\uff09\u3001ISO\/TS 23565\uff08\u7d30\u80de\u6cbb\u7642\u88fd\u54c1\u88fd\u9020\u88c5\u7f6e\uff09\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u3010\u6700\u512a\u5148\u30fb\u72ec\u7acb\u7ae0\u3011\u514d\u75ab\u5b66\uff08\u540c\u7a2e\u79fb\u690d\u514d\u75ab\u30fbHLA\u30fb\u514d\u75ab\u5bdb\u5bb9\u30fbuniversal donor\uff09<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>\u306a\u305c\u5fc5\u8981\u304b<\/em>\uff1aiPS\u6642\u4ee3\u306e\u4ed6\u5bb6\uff08\u30a2\u30ed\uff09\u88fd\u54c1\u304c\u4e3b\u6d41\u5316\u3002\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea\u3082\u300c\u975e\u81ea\u5df1\u300diPS\u7531\u6765\u3002HLA\u30de\u30c3\u30c1\u30f3\u30b0\u6226\u7565\u3001NK\u7d30\u80de\u4ecb\u5728\u62d2\u7d76\u3001\u30b2\u30ce\u30e0\u7de8\u96c6\u306b\u3088\u308b\u4f4e\u514d\u75ab\u539f\u6027\u30fbuniversal donor\u5316\u306f\u88fd\u54c1\u9078\u629e\u30fb\u514d\u75ab\u6291\u5236\u4f75\u7528\u30fb\u9069\u5fdc\u5224\u65ad\u306b\u76f4\u7d50\u3059\u308b\u3002<\/li>\n\n\n\n<li>\u4e00\u6b21\u60c5\u5831\uff1a\u4eac\u90fd\u5927\u5b66iPS\u7d30\u80de\u7814\u7a76\u6240\uff08CiRA\uff09iPS\u7d30\u80de\u30b9\u30c8\u30c3\u30af\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3002\u6700\u983b\u5ea6HLA\u30db\u30e2\u63a5\u5408\u4f53\u682a\u5358\u72ec\u3067\u65e5\u672c\u4eba\u306e\u7d0417%\u3092\u30ab\u30d0\u30fc\uff08CiRA, 2017\uff09\u3001\u30c9\u30ca\u30fc\u30ea\u30af\u30eb\u30fc\u30c8\u9032\u5c55\u306b\u3088\u308a\u7d0440%\u30ab\u30d0\u30fc\uff08\u4eac\u5927iPS\u7d30\u80de\u7814\u7a76\u8ca1\u56e3, 2025\u5e742\u6708\uff09\u3002CiRA 2019\u5e747\u670831\u65e5\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9\u306b\u3088\u308c\u3070\u3001HLA-A\u907a\u4f1d\u5b50\u30fbHLA-B\u907a\u4f1d\u5b50\u304a\u3088\u3073HLA-Class II\u767a\u73fe\u306b\u91cd\u8981\u306aCIITA\u907a\u4f1d\u5b50\u3092CRISPR-Cas9\u3067\u7834\u58ca\u3057\u305f\u682a\u3092\u7528\u3044\u308c\u3070\u300cHLA-C\u306e\u578b\u306e\u307f\u305d\u308d\u3048\u308c\u3070\u826f\u3044\u305f\u3081\u3001\u65e5\u672c\u4eba\u306e95%\u3092\u30ab\u30d0\u30fc\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u682a\u6570\u306f7\u682a\u3068\u8a66\u7b97\u300d\u3002AMED\u300ciPS\u7d30\u80de\u30b9\u30c8\u30c3\u30af\u3092\u7528\u3044\u305f\u79fb\u690d\u306e\u305f\u3081\u306e\u65b0\u898f\u514d\u75ab\u6291\u5236\u6cd5\u300d\uff082022\u5e743\u6708\uff09\u3002\u65e2\u5b58\u7b2c3\u7ae0\uff08iPS\uff09\u30fb\u7b2c4\u7ae0\u3067\u306f\u514d\u75ab\u5b66\u306e\u6271\u3044\u304c\u8584\u3044\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u3010\u6700\u512a\u5148\u30fb\u72ec\u7acb\u7ae0\u3011\u4fdd\u967a\u511f\u9084\u30fb\u533b\u7642\u7d4c\u6e08\u30fb\u85ac\u4fa1<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>\u306a\u305c\u5fc5\u8981\u304b<\/em>\uff1a\u6570\u5343\u4e07\u5186\u88fd\u54c1\u306e\u4fdd\u967a\u9069\u7528\u53ef\u5426\u30fb\u9662\u5185\u63a1\u7b97\u30fb\u30ad\u30e3\u30c3\u30b7\u30e5\u30d5\u30ed\u30fc\u306f\u7d4c\u55b6\u306e\u751f\u547d\u7dda\u3002<\/li>\n\n\n\n<li>\u65b0\u8a2d\u7ae0\u6848\uff1a\u65e5\u672c\u306e\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u85ac\u4fa1\u7b97\u5b9a\uff08\u539f\u4fa1\u8a08\u7b97\u65b9\u5f0f\u3001\u5e02\u5834\u6027\u52a0\u7b97\u30fb\u5148\u99c6\u52a0\u7b97\u3001\u6761\u4ef6\u30fb\u671f\u9650\u4ed8\u627f\u8a8d\u54c1\u306e\u4fa1\u683c\u7b97\u5b9a\u30eb\u30fc\u30eb\u30142026\u5e741\u6708\u9069\u7528\u3015\uff09\u3001\u8cbb\u7528\u5bfe\u52b9\u679c\u8a55\u4fa1\uff08\u4e2d\u533b\u5354\/C2H\uff09\u3001\u6210\u679c\u9023\u52d5\u578b\u652f\u6255\u3044\uff08outcomes-based agreement\uff0fannuity\uff0fwarranty\uff0fsubscription\uff09\u306e\u56fd\u969b\u52d5\u5411\u3068\u30b3\u30b9\u30c8\u30fb\u30c7\u30f3\u30b7\u30c6\u30a3\u554f\u984c\u3002<\/li>\n\n\n\n<li>\u4e00\u6b21\u60c5\u5831\uff1a\u56fd\u7acb\u4fdd\u5065\u533b\u7642\u79d1\u5b66\u9662 \u4fdd\u5065\u533b\u7642\u7d4c\u6e08\u8a55\u4fa1\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\uff08C2H\uff09\u300c\u4e2d\u592e\u793e\u4f1a\u4fdd\u967a\u533b\u7642\u5354\u8b70\u4f1a\u306b\u304a\u3051\u308b\u8cbb\u7528\u5bfe\u52b9\u679c\u8a55\u4fa1\u306e\u5206\u6790\u30ac\u30a4\u30c9\u30e9\u30a4\u30f32024\u5e74\u5ea6\u7248\u300d\u304a\u3088\u3073\u300c\u5206\u6790\u7d50\u679c\u306e\u8a18\u8f09\u69d8\u5f0f\u3068\u624b\u5f15 \u7b2c2.0\u7248\u300d\uff082024\u5e744\u6708\uff09\u3001\u4e2d\u533b\u5354\u7dcf\u4f1a\u8cc7\u6599\u3001\u7c73CMMI\/Medicaid outcomes-based payment pilot\uff08Brookings, McKinsey\u7b49\u306e\u89e3\u8aac\uff09\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u3010\u9ad8\u3011\u533b\u7642\u6a5f\u95a2\u7d4c\u55b6\u30fb\u518d\u751f\u533b\u7642\u90e8\u9580\u306e\u904b\u55b6<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>\u306a\u305c\u5fc5\u8981\u304b<\/em>\uff1a\u4ee3\u8868\u7406\u4e8b\u306e\u4e2d\u6838\u95a2\u5fc3\u3002\u90e8\u9580\u7acb\u3061\u4e0a\u3052\u3001\u65bd\u8a2d\u6295\u8cc7\u56de\u53ce\u3001\u591a\u8077\u7a2e\u30c1\u30fc\u30e0\u7de8\u6210\u3001\u8a8d\u5b9a\u533b\u30fb\u6280\u8853\u8005\u5236\u5ea6\u3001\u4eba\u6750\u80b2\u6210\u3001\u8853\u8005\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3002<\/li>\n\n\n\n<li>\u4e00\u6b21\u60c5\u5831\uff1a\u65e5\u672c\u518d\u751f\u533b\u7642\u5b66\u4f1a \u8a8d\u5b9a\u5236\u5ea6\uff08\u518d\u751f\u533b\u7642\u8a8d\u5b9a\u533b\u3001\u81e8\u5e8a\u57f9\u990a\u58eb\u3001\u4e0a\u7d1a\u81e8\u5e8a\u57f9\u990a\u58eb\u3001\u7d30\u80de\u57f9\u990a\u52a0\u5de5\u65bd\u8a2d\u7ba1\u7406\u58eb\u3001\u518d\u751f\u533b\u7642\u8a8d\u5b9a\u65bd\u8a2d\uff09\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u3010\u9ad8\u3011\u533b\u7642\u5b89\u5168\u30fb\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30fb\u6709\u5bb3\u4e8b\u8c61\u5bfe\u5fdc\u306e\u5b9f\u52d9<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>\u306a\u305c\u5fc5\u8981\u304b<\/em>\uff1a\u91cd\u7be4\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u30d5\u30ed\u30fc\u30fb\u5065\u5eb7\u88ab\u5bb3\u6551\u6e08\u5236\u5ea6\u306f\u6cd5\u7684\u8cac\u52d9\u3067\u3042\u308a\u3001\u4ee3\u8868\u7406\u4e8b\u304c\u4f53\u5236\u69cb\u7bc9\u8cac\u4efb\u3092\u8ca0\u3046\u3002<\/li>\n\n\n\n<li>\u4e00\u6b21\u60c5\u5831\uff1aPMDA\u300c\u4e0d\u5177\u5408\u7b49\u304c\u7591\u308f\u308c\u308b\u75c7\u4f8b\u5831\u544a\u306b\u95a2\u3059\u308b\u60c5\u5831\uff08\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\uff09\u300d\u300c\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\uff08\u52a0\u5de5\u7d30\u80de\u7b49\uff09\u306e\u6cbb\u9a13\u4e2d\u4e0d\u5177\u5408\u7b49\u5831\u544a\u5236\u5ea6\u300d\u3001\u751f\u7269\u7531\u6765\u88fd\u54c1\u611f\u67d3\u7b49\u88ab\u5bb3\u6551\u6e08\u5236\u5ea6\uff08PMDA\uff09\u3001FIRM\u300c\u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u4e0d\u5177\u5408\u30fb\u611f\u67d3\u75c7\u75c7\u4f8b\u5831\u544a\u7b49\u4f5c\u6210\u306e\u624b\u5f15\u304d\u300d\uff082023\u5e747\u6708\uff09\u3001GVP\/GCTP\u7701\u4ee4\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u3010\u9ad8\u3011\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30fb\u30ec\u30b8\u30b9\u30c8\u30ea\u30fb\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30c7\u30fc\u30bf\uff08RWD\uff09<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>\u306a\u305c\u5fc5\u8981\u304b<\/em>\uff1a\u6761\u4ef6\u30fb\u671f\u9650\u4ed8\u627f\u8a8d\u54c1\u306e\u5168\u4f8b\u8abf\u67fb\u30fb\u5e02\u8ca9\u5f8c\u6709\u52b9\u6027\u691c\u8a3c\u306e\u57fa\u76e4\u3067\u3042\u308a\u3001\u627f\u8a8d\u7dad\u6301\u306e\u751f\u547d\u7dda\u3002<\/li>\n\n\n\n<li>\u4e00\u6b21\u60c5\u5831\uff1a\u65e5\u672c\u518d\u751f\u533b\u7642\u5b66\u4f1a\u304c\u69cb\u7bc9\u30fb\u904b\u7528\u3059\u308bNRMD\uff08National Regenerative Medicine Database\uff09\u304a\u3088\u3073NRMD\/CR\uff08\u81e8\u5e8a\u7814\u7a76\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\uff09\u3001REAP\u3001\u6b21\u4e16\u4ee3\u533b\u7642\u57fa\u76e4\u6cd5\u3002\u305f\u3060\u3057NRMD\u306f\u81e8\u5e8a\u7814\u7a76\u30fb\u5148\u9032\u533b\u7642\u30fb\u6cbb\u9a13\u30fb\u88fd\u9020\u8ca9\u58f2\u5f8c\u8abf\u67fb\u304c\u5bfe\u8c61\u3067\u3001\u81ea\u7531\u8a3a\u7642\u306f\u539f\u5247\u60f3\u5b9a\u5916\u3067\u3042\u308b\u70b9\uff08\u4f50\u85e4\u967d\u6cbb, \u56fd\u7acb\u533b\u85ac\u54c1\u98df\u54c1\u885b\u751f\u7814\u7a76\u6240\u8cc7\u6599, 2021\/2025\uff09\u306f\u7d4c\u55b6\u8005\u304c\u7406\u89e3\u3059\u3079\u304d\u5236\u5ea6\u4e0a\u306e\u30ae\u30e3\u30c3\u30d7\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u3010\u9ad8\u3011\u30a2\u30b8\u30a2\u30fb\u305d\u306e\u4ed6\u56fd\u969b\u898f\u5236\uff08\u65e5\u7c73\u6b27\u4e09\u6975\u4ee5\u5916\uff09<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>\u306a\u305c\u5fc5\u8981\u304b<\/em>\uff1a\u65e2\u5b58\u7b2c\u2162\u90e8\uff08\u7b2c12\u301c14\u7ae0\uff09\u306f\u65e5\u7c73\u6b27\u306e\u307f\u3002\u6d77\u5916\u5c55\u958b\u30fb\u5c0e\u51fa\u5165\u6226\u7565\u306b\u4e0d\u53ef\u6b20\u306a\u8996\u70b9\u304c\u6b20\u843d\u3002<\/li>\n\n\n\n<li>\u4e00\u6b21\u60c5\u5831\uff1a\u4e2d\u56fd\u306eOrder No.818\u300c\u751f\u7269\u533b\u5b66\u65b0\u6280\u8853\u306e\u81e8\u5e8a\u7814\u7a76\u3068\u81e8\u5e8a\u5fdc\u7528\u306e\u7ba1\u7406\u6761\u4f8b\u300d\uff082026\u5e745\u67081\u65e5\u65bd\u884c\u3001NMPA\u85ac\u4e8b\u30eb\u30fc\u30c8\u3068NHC\u533b\u7642\u6280\u8853\u30eb\u30fc\u30c8\u306e\u4e8c\u5143\u7684\u67a0\u7d44\u307f\uff09\u3001\u97d3\u56fd Advanced Regenerative Medicine Act\uff08\u5148\u9032\u518d\u751f\u533b\u7642\u6cd5\u3001\u6761\u4ef6\u4ed8\u627f\u8a8d\u3068MFDS\/Advanced Biological Products\uff09\u3001\u82f1\u56fdMHRA\uff08Brexit\u5f8c\u30fbpoint-of-care\u88fd\u9020\uff09\u3001\u8c6aTGA\u3001\u30ab\u30ca\u30c0\u3001ISO TC276\uff08WG1\u301c5\uff1a\u7528\u8a9e\/\u30d0\u30a4\u30aa\u30d0\u30f3\u30ad\u30f3\u30b0\/\u5206\u6790\u6cd5\/\u30d0\u30a4\u30aa\u30d7\u30ed\u30bb\u30b7\u30f3\u30b0\/\u30c7\u30fc\u30bf\uff09\u3001WHO\u306e\u7d30\u80de\u30fb\u907a\u4f1d\u5b50\u6cbb\u7642\u88fd\u54c1\u306e\u898f\u5236\u53ce\u6582\u306b\u95a2\u3059\u308b\u691c\u8a0e\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u3010\u4e2d\u3011\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u30fb\u7d30\u80de\u5916\u5c0f\u80de\uff08EV\uff09\u30fb\u57f9\u990a\u4e0a\u6e05\u306e\u898f\u5236\u3068\u54c1\u8cea<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>\u306a\u305c\u5fc5\u8981\u304b<\/em>\uff1a\u81ea\u7531\u8a3a\u7642\u3067\u6025\u62e1\u5927\u3057\u3064\u3064\u5b89\u78ba\u6cd5\u5bfe\u8c61\u5916\u3068\u3044\u3046\u898f\u5236\u306e\u7a7a\u767d\u5730\u5e2f\u3002\u4eac\u90fd\u5927\u5b66\u30b0\u30eb\u30fc\u30d7\u306e\u56fd\u969b\u5831\u544a\uff08Stem Cell Reports, 2024\u5e7410\u6708\uff09\u306b\u3088\u308c\u30702023\u5e74\u306b669\u306e\u533b\u7642\u6a5f\u95a2\u304c\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u6cbb\u7642\u3092\u63d0\u4f9b\u3002\u7d30\u80de\u3092\u542b\u307e\u306a\u3044\u305f\u3081\u5b89\u78ba\u6cd5\u306e\u898f\u5236\u5bfe\u8c61\u5916\u3067\u3042\u308b\u3053\u3068\u306e\u30ea\u30b9\u30af\u306f\u4ee3\u8868\u7406\u4e8b\u304c\u7d4c\u55b6\u5224\u65ad\u4e0a\u628a\u63e1\u3059\u3079\u304d\u3002\u65e2\u5b58\u7b2c29\u7ae0\u306fEV\u306e\u81e8\u5e8a\u5fdc\u7528\u4e2d\u5fc3\u3067\u3001\u898f\u5236\u30fb\u54c1\u8cea\u30fb\u81ea\u7531\u8a3a\u7642\u30ea\u30b9\u30af\u3092\u6271\u3063\u3066\u3044\u306a\u3044\u3002<\/li>\n\n\n\n<li>\u4e00\u6b21\u60c5\u5831\uff1aPMDA\u300c\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u3092\u542b\u3080\u7d30\u80de\u5916\u5c0f\u80de\uff08EV\uff09\u3092\u5229\u7528\u3057\u305f\u6cbb\u7642\u7528\u88fd\u5264\u306b\u95a2\u3059\u308b\u5c02\u9580\u90e8\u4f1a\u5831\u544a\u66f8\u300d\uff082023\u5e741\u670817\u65e5\u3001\u82f1\u8a33\u7248 Pharm Res 2024, Takakura Y et al.\uff09\u3001\u65e5\u672c\u518d\u751f\u533b\u7642\u5b66\u4f1a\u300c\u7d30\u80de\u5916\u5c0f\u80de\u7b49\u306e\u81e8\u5e8a\u5fdc\u7528\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\uff08\u7b2c1\u7248\uff09\u300d\uff082024\u5e74\uff09\u3001\u539a\u751f\u52b4\u50cd\u7701\u533b\u653f\u5c40\u7814\u7a76\u958b\u767a\u653f\u7b56\u8ab2 \u4e8b\u52d9\u9023\u7d61\u300c\u5e79\u7d30\u80de\u57f9\u990a\u4e0a\u6e05\u6db2\u53ca\u3073\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u7b49\u3092\u7528\u3044\u308b\u533b\u7642\u306b\u3064\u3044\u3066\u300d\uff08\u4ee4\u548c6\u5e747\u670831\u65e5\uff09\u304a\u3088\u3073\u540c\u65e5\u4ed8 \u533b\u85ac\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\u300c\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u8a66\u85ac\u306b\u4fc2\u308b\u76e3\u8996\u6307\u5c0e\u306b\u3064\u3044\u3066\u300d\u3001\u539a\u751f\u52b4\u50cd\u79d1\u5b66\u7279\u5225\u7814\u7a76\u4e8b\u696d\u300c\u518d\u751f\u533b\u7642\u7b49\u5b89\u5168\u6027\u78ba\u4fdd\u6cd5\u306b\u304a\u3051\u308b\u30ea\u30b9\u30af\u5206\u985e\u306e\u898b\u76f4\u3057\u306b\u8cc7\u3059\u308b\u8abf\u67fb\u7814\u7a76\u300d\u7dcf\u62ec\u7814\u7a76\u5831\u544a\uff082025\u5e746\u670813\u65e5\u3001\u7814\u7a76\u4ee3\u8868\u8005\uff1a\u5ca1\u7530\u6f54\uff09\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">B. \u65e2\u5b58\u7ae0\u306b\u52a0\u7b46\u30fb\u62e1\u5145\u3059\u3079\u304d\u9805\u76ee<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u7b2c7\u301c9\u7ae0\uff08\u65e5\u672c\u898f\u5236\uff09<\/strong>\uff1a\u6539\u6b63\u5b89\u78ba\u6cd5\uff082025\u5e745\u670831\u65e5\u65bd\u884c\u3001in vivo\u907a\u4f1d\u5b50\u6cbb\u7642\u306e\u7b2c\u4e00\u7a2e\u53d6\u308a\u8fbc\u307f\u3001\u8a8d\u5b9a\u59d4\u54e1\u4f1a\u3078\u306e\u7acb\u5165\u691c\u67fb\u3001\u7d30\u80de\u52a0\u5de5\u7269\u3092\u7528\u3044\u306a\u3044\u907a\u4f1d\u5b50\u6cbb\u7642\u306e\u898f\u5236\uff09\u3001\u9069\u5fdc\u5916\u4f7f\u7528\u306e\u7279\u5b9a\u81e8\u5e8a\u7814\u7a76\u30fb\u518d\u751f\u533b\u7642\u7b49\u304b\u3089\u306e\u9664\u5916\u3001\u6761\u4ef6\u30fb\u671f\u9650\u4ed8\u627f\u8a8d\u54c1\u306e\u4fa1\u683c\u7b97\u5b9a\u30eb\u30fc\u30eb\uff082026\u5e741\u6708\uff09\u3092\u52a0\u7b46\u3002\u7570\u7a2e\u79fb\u690d\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff082025\u5e741\u670817\u65e5\u901a\u77e5\uff09\u3082\u53cd\u6620\u3002\u3010\u9ad8\u3011<\/li>\n\n\n\n<li><strong>\u7b2c\u2163\u90e8 \u8a3a\u7642\u79d1\u5225\uff08\u7b2c16\u301c23\u7ae0\uff09<\/strong>\uff1a\u8033\u9f3b\u54bd\u5589\u79d1\uff08\u8074\u899a\u30fb\u55c5\u899a\u518d\u751f\u3092\u7b2c23\u7ae0\u304b\u3089\u72ec\u7acb\u62e1\u5145\uff09\u3001\u814e\u81d3\u5185\u79d1\uff08\u900f\u6790\/CKD\u30fb\u6025\u6027\u814e\u969c\u5bb3\u3078\u306eMSC\/EV\u7642\u6cd5\uff1aClinicalTrials.gov\u306746\u8a66\u9a13\u898f\u6a21\uff09\u3001\u30ea\u30cf\u30d3\u30ea\u30c6\u30fc\u30b7\u30e7\u30f3\u79d1\uff08\u7d30\u80de\u6cbb\u7642\u4f75\u7528\u30ea\u30cf\uff09\u3001\u9ebb\u9154\u30fb\u75bc\u75db\uff08\u6162\u6027\u75bc\u75db\u30fb\u690e\u9593\u677f\u5909\u6027\uff09\u3001\u751f\u6b96\u533b\u7642\u30fb\u5973\u6027\u533b\u5b66\u3001\u7dda\u7dad\u75c7\u6027\u75be\u60a3\uff08\u814e\u30fb\u80ba\u30fb\u809d\u306e\u6a2a\u65ad\u7684\u7dda\u7dad\u5316\uff09\u3001\u52a0\u9f62\u30fb\u8001\u5316\uff08\u30bb\u30cd\u30c3\u30bb\u30f3\u30b9\uff09\u3001\u5275\u50b7\u6cbb\u7652\u30fb\u71b1\u50b7\u306e\u8a73\u7d30\u3001\u6bdb\u9aea\u30fb\u76ae\u819a\u4ed8\u5c5e\u5668\u3001\u9aa8\u683c\u7b4b\u3001\u672b\u68a2\u795e\u7d4c\u518d\u751f\u3092\u52a0\u7b46\u3002\u3010\u4e2d\u301c\u9ad8\u3011<\/li>\n\n\n\n<li><strong>\u7b2c5\u7ae0\uff08\u7d44\u7e54\u5de5\u5b66\u30fb\u30d0\u30a4\u30aa\u30de\u30c6\u30ea\u30a2\u30eb\uff09<\/strong>\uff1a\u8840\u7ba1\u65b0\u751f\u30fb\u7d44\u7e54\u8840\u7ba1\u5316\u3001\u30e1\u30ab\u30ce\u30d0\u30a4\u30aa\u30ed\u30b8\u30fc\u3001\u5fae\u5c0f\u74b0\u5883\u30fb\u30cb\u30c3\u30c1\u5de5\u5b66\u3001\u30d0\u30a4\u30aa\u30ea\u30a2\u30af\u30bf\u30fc\u3092\u62e1\u5145\uff08Atala 3rd Part III\u3001Steinhoff Vol.3\u6c34\u6e96\u3092\u53c2\u7167\uff09\u3002\u3010\u4e2d\u3011<\/li>\n\n\n\n<li><strong>\u7b2c6\u7ae0\uff08\u30b2\u30ce\u30e0\u7de8\u96c6\uff09\uff0f\u7b2c29\u7ae0<\/strong>\uff1a\u30a6\u30a4\u30eb\u30b9\u30d9\u30af\u30bf\u30fc\uff08AAV\u7b49\uff09\u30fbLNP\u306eGMP\u88fd\u9020\u306e\u8a73\u7d30\u3068\u4f9b\u7d66\u5236\u7d04\u3092\u52a0\u7b46\u3002\u3010\u4e2d\u3011<\/li>\n\n\n\n<li><strong>\u7b2c24\u301c25\u7ae0\uff08\u502b\u7406\u30fbIC\uff09<\/strong>\uff1aiPS\u88fd\u54c1\u306e\u8d85\u9ad8\u85ac\u4fa1\u3068\u533b\u7642\u8cc7\u6e90\u914d\u5206\u3001\u6761\u4ef6\u30fb\u671f\u9650\u4ed8\u627f\u8a8d\u54c1\u3078\u306e\u60a3\u8005\u56e3\u4f53\u30fb\u85ac\u5bb3\u30aa\u30f3\u30d6\u30ba\u30d1\u30fc\u30b9\u30f3\u4f1a\u8b70\u304b\u3089\u306e\u627f\u8a8d\u53d6\u6d88\u30fb\u4fdd\u967a\u9069\u7528\u53cd\u5bfe\u306e\u610f\u898b\u66f8\uff082026\u5e744\u6708\uff09\u7b49\u3001\u5b9f\u88c5\u671f\u7279\u6709\u306e\u8ad6\u70b9\u3092\u8ffd\u52a0\u3002\u300c\u6709\u52b9\u6027\u304c\u63a8\u5b9a\u306b\u3068\u3069\u307e\u308b\u300d\u88fd\u54c1\u3078\u306e\u6cbb\u7642\u7684\u8aa4\u89e3\u306e\u30ea\u30b9\u30af\u3092\u62e1\u5145\u3002\u3010\u9ad8\u3011<\/li>\n\n\n\n<li><strong>\u7b2c26\u7ae0\uff08\u672a\u627f\u8a8d\u30fb\u5e79\u7d30\u80de\u30c4\u30fc\u30ea\u30ba\u30e0\uff09<\/strong>\uff1a\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u30fb\u57f9\u990a\u4e0a\u6e05\u306e\u81ea\u7531\u8a3a\u7642\u3001\u533b\u7642\u5e83\u544a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff082018\u5e746\u6708\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u898f\u5236\u65bd\u884c\u3001\u300c\u627f\u8a8d\u300d\u3068\u8aa4\u8a8d\u3055\u305b\u308b\u8868\u8a18\u306e\u7981\u6b62\uff1d\u5b89\u78ba\u6cd5\u306f\u300c\u5c4a\u51fa\u300d\u5236\uff09\u3001\u6df7\u5408\u8a3a\u7642\u554f\u984c\u3092\u62e1\u5145\u3002\u65e5\u672c\u518d\u751f\u533b\u7642\u5b66\u4f1a\u300c\u81ea\u7531\u8a3a\u7642\u306b\u304a\u3051\u308b\u5e83\u544a\u306b\u95a2\u3059\u308b\u6ce8\u610f\u559a\u8d77\u300d\u3092\u53c2\u7167\u3002\u3010\u9ad8\u3011<\/li>\n\n\n\n<li><strong>\u7b2c27\u7ae0\uff08\u7523\u696d\u5316\u30fb\u77e5\u8ca1\u30fb\u533b\u7642\u7d4c\u6e08\uff09<\/strong>\uff1aCDMO\u6c34\u5e73\u5206\u696d\u3001\u6210\u679c\u9023\u52d5\u578b\u652f\u6255\u3044\u3001\u56fd\u969b\u5171\u540c\u958b\u767a\u30fbICH\u3001\u74b0\u5883\u30fb\u6301\u7d9a\u53ef\u80fd\u6027\uff08\u88fd\u9020\u306e\u74b0\u5883\u8ca0\u8377\uff09\u3092\u62e1\u5145\u3002\u3010\u4e2d\u3011<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Recommendations<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u5373\u6642\uff08\u7b2c2\u7248\u6539\u8a02\u306e\u9aa8\u5b50\uff09<\/strong>\uff1a\u72ec\u7acb3\u7ae0\u300c\u7d30\u80de\u88fd\u9020\u30fbCMC\u30fb\u54c1\u8cea\u5206\u6790\u300d\u300c\u514d\u75ab\u5b66\u30fb\u30a2\u30ed\u79fb\u690d\u6226\u7565\u300d\u300c\u4fdd\u967a\u511f\u9084\u30fb\u533b\u7642\u7d4c\u6e08\u300d\u3092\u65b0\u8a2d\u3057\u3001\u7b2c\u2161\u90e8\u898f\u5236\u7ae0\u306biPS\u88fd\u54c1\u627f\u8a8d\u30fb\u6539\u6b63\u5b89\u78ba\u6cd5\u30fb\u85ac\u4fa1\u7b97\u5b9a\u3092\u5168\u9762\u52a0\u7b46\u3059\u308b\u3002\u3053\u308c\u304c\u7d4c\u55b6\u5c64\u8aad\u8005\u306b\u3068\u3063\u3066\u306eROI\u304c\u6700\u3082\u9ad8\u3044\uff08\u610f\u601d\u6c7a\u5b9a\u306e\u983b\u5ea6\u3068\u91d1\u984d\u898f\u6a21\u306e\u4e21\u9762\u3067\uff09\u3002<\/li>\n\n\n\n<li><strong>\u6b21\u6bb5\u968e<\/strong>\uff1a\u300c\u533b\u7642\u6a5f\u95a2\u7d4c\u55b6\u30fb\u90e8\u9580\u904b\u55b6\u300d\u300c\u533b\u7642\u5b89\u5168\u30fb\u6709\u5bb3\u4e8b\u8c61\u5bfe\u5fdc\u300d\u300c\u30ec\u30b8\u30b9\u30c8\u30ea\/RWD\u300d\u300c\u30a2\u30b8\u30a2\u30fb\u305d\u306e\u4ed6\u56fd\u969b\u898f\u5236\u300d\u300cEV\u30fb\u57f9\u990a\u4e0a\u6e05\u306e\u898f\u5236\u3068\u54c1\u8cea\u300d\u306e5\u7ae0\u3092\u8ffd\u52a0\u3057\u3001\u51686\u90e830\u7ae0\u2192\u51688\u90e840\u7ae0\u7a0b\u5ea6\u3078\u62e1\u5f35\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u5224\u65ad\u57fa\u6e96\u306e\u95be\u5024\uff08\u6539\u8a02\u30c8\u30ea\u30ac\u30fc\uff09<\/strong>\uff1a(a) iPS\u7531\u6765\u88fd\u54c1\u304c\u7d2f\u8a085\u54c1\u76ee\u4ee5\u4e0a\u627f\u8a8d\u3055\u308c\u4fdd\u967a\u8ca1\u653f\u30fb\u8cbb\u7528\u5bfe\u52b9\u679c\u8a55\u4fa1\u304c\u672c\u683c\u8b70\u8ad6\u306b\u5165\u3063\u305f\u6bb5\u968e\u3001(b) \u5b89\u78ba\u6cd5\u30ea\u30b9\u30af\u5206\u985e\u898b\u76f4\u3057\u306e\u653f\u4ee4\u30fb\u7701\u4ee4\u304c\u78ba\u5b9a\u3057\u305f\u6bb5\u968e\uff08\u57f9\u990a\u4e0a\u6e05\u30fb\u30a8\u30af\u30bd\u30bd\u30fc\u30e0\u304c\u5b89\u78ba\u6cd5\u5bfe\u8c61\u5316\u3055\u308c\u305f\u5834\u5408\uff09\u3001(c) \u4e2d\u56fdOrder 818\u3084\u97d3\u56fd\u5148\u9032\u518d\u751f\u533b\u7642\u6cd5\u306e\u904b\u7528\u5b9f\u7e3e\u304c\u84c4\u7a4d\u3057\u305f\u6bb5\u968e\u2014\u2014\u306e\u3044\u305a\u308c\u304b\u3067\u7d4c\u55b6\u30fb\u898f\u5236\u7ae0\u3092\u518d\u6539\u8a02\u3059\u308b\u3002<\/li>\n\n\n\n<li><strong>\u30d9\u30f3\u30c1\u30de\u30fc\u30af\u65b9\u91dd<\/strong>\uff1aAtala\/Lanza\uff08Part III\uff1dBiomaterials\u72ec\u7acb\u3001Part V\uff1dRegulation and Ethics\uff09\u3001Steinhoff\uff08Vol.3\uff1dTissue Engineering\/Biomaterials\/Nanotech\u72ec\u7acb\u3001Vol.4\u306b\u898f\u5236\u30fb\u502b\u7406\u30fb\u524d\u81e8\u5e8a\uff09\u3001\u65e5\u672c\u518d\u751f\u533b\u7642\u5b66\u4f1a\u30c6\u30ad\u30b9\u30c8\uff08\u7b2c3\u90e8\u5168\u4f53\uff1d\u88fd\u9020\u306e5\u7ae0\uff09\u3092\u53c2\u7167\u3057\u3001<strong>\u300c\u88fd\u9020\u30fbCMC\u90e8\u9580\u306e\u72ec\u7acb\u300d\u3092\u6700\u512a\u5148<\/strong>\u3068\u3059\u308b\u3002\u65e5\u672c\u306e\u6559\u79d1\u66f8\u306f\u88fd\u9020\u30fb\u54c1\u8cea\u306b\u539a\u304f\u3001\u6b27\u7c73\u66f8\u306f\u57fa\u790e\u751f\u7269\u5b66\u30fb\u30d0\u30a4\u30aa\u30de\u30c6\u30ea\u30a2\u30eb\u306b\u539a\u3044\u305f\u3081\u3001\u672c\u66f8\u306f\u4e21\u8005\u306e\u9577\u6240\u306b\u52a0\u3048\u3066\u7d4c\u55b6\u30fb\u511f\u9084\u30fb\u514d\u75ab\u306e3\u8ef8\u3092\u72ec\u81ea\u306e\u5f37\u307f\u3068\u3059\u3079\u304d\u3002<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">Caveats<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u85ac\u4fa1\u30fb\u60a3\u8005\u6570\uff08\u30a2\u30e0\u30b7\u30a7\u30d7\u30ea 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818\u306e\u65bd\u884c\u65e5\u30fb\u904b\u7528\u7d30\u5247\u3001\u5b89\u78ba\u6cd5\u30ea\u30b9\u30af\u5206\u985e\u898b\u76f4\u3057\u306e\u6700\u7d42\u7684\u306a\u653f\u7701\u4ee4\u5316\u306f\u6d41\u52d5\u7684\u3067\u3042\u308a\u3001\u57f7\u7b46\u6642\u70b9\uff082026\u5e747\u6708\uff09\u4ee5\u964d\u306e\u8ffd\u8de1\u304c\u5fc5\u8981\u3002<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"TL;DR Key Findings 1. \u69cb\u6210\u4e0a\u306e\u6839\u672c\u7684\u6b20\u843d\uff08\u72ec\u7acb\u7ae0\u30fb\u72ec\u7acb\u90e8\u30ec\u30d9\u30eb\uff09 \u65e2\u5b58\u69cb\u6210\u306f\u81e8\u5e8a\u5fdc\u7528\uff08\u7b2c\u2163\u90e88\u7ae0\uff09\u3068\u898f\u5236\uff08\u7b2c\u2161\u30fb\u2162\u90e8\uff09\u306b\u539a\u3044\u4e00\u65b9\u3001Atala\/Lanza\u300ePrinciples of Regenera 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