{"id":8365,"date":"2026-08-11T18:17:41","date_gmt":"2026-08-11T15:17:41","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=8365"},"modified":"2026-08-11T18:30:12","modified_gmt":"2026-08-11T15:30:12","slug":"fda-expands-signature-biologics-dmd-study","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/zh\/fda-expands-signature-biologics-dmd-study\/","title":{"rendered":"FDA \u5141\u8bb8\u6269\u5927 Signature Biologics&#039; DMD \u7ec6\u80de\u7597\u6cd5\u7814\u7a76\u7684\u5165\u7ec4\u4eba\u6570"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Signature Biologics \u5ba3\u5e03\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u5df2\u6279\u51c6\u6269\u5927\u4e00\u9879\u4e34\u5e8a\u7814\u7a76\u7684\u5165\u7ec4\u4eba\u6570\uff0c\u8be5\u7814\u7a76\u65e8\u5728\u8bc4\u4f30\u8be5\u516c\u53f8\u7528\u4e8e\u6cbb\u7597\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7 (DMD) \u7684\u5728\u7814\u8110\u5e26\u95f4\u5145\u8d28\u5e72\u7ec6\u80de (UC-MSC) \u7597\u6cd5\u3002.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u7814\u7a76\u662f\u5728\u53d7\u59d4\u6258\u7684\u5408\u540c\u7814\u7a76\u7ec4\u7ec7\uff08CRO\uff09\u6301\u6709\u7684\u65b0\u836f\u7814\u7a76\u7533\u8bf7\uff08IND\uff09\u4e0b\u8fdb\u884c\u7684\uff0c\u8be5CRO\u540c\u65f6\u4e5f\u662f\u672c\u7814\u7a76\u7684\u7533\u529e\u65b9\u3002Signature Biologics\u8d1f\u8d23\u751f\u4ea7\u7814\u7a76\u7528\u836f\u54c1\u5e76\u8d44\u52a9\u672c\u7814\u7a76\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9996\u6279\u4e94\u540d\u53c2\u4e0e\u8005\u5df2\u5b8c\u6210\u5165\u7ec4\u3002\u8fd9\u9879\u5f00\u653e\u6807\u7b7e\u3001\u5386\u53f2\u5bf9\u7167\u7814\u7a76\u5305\u62ec\u529f\u80fd\u8bc4\u4f30\uff0c\u4f8b\u5982\u56db\u7ea7\u53f0\u9636\u722c\u53d6\u6d4b\u8bd5\u3001\u5341\u7c73\u6b65\u884c\u6d4b\u8bd5\u548c\u5317\u6781\u661f\u6b65\u884c\u8bc4\u4f30\uff08NSAA\uff09\uff0c\u4ee5\u53ca PedsQL DMD \u548c\u75b2\u52b3\u8bc4\u4f30\u3001\u4ee3\u8c22\u5b9e\u9a8c\u5ba4\u68c0\u6d4b\u548c\u708e\u75c7\u7ec6\u80de\u56e0\u5b50\u8c31\u68c0\u6d4b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u636e\u8be5\u516c\u53f8\u79f0\uff0cFDA \u5141\u8bb8\u6700\u591a\u989d\u5916\u62db\u52df 30 \u540d\u53c2\u4e0e\u8005\u3002.<\/strong> \u5f85\u65b0\u589e\u4e34\u5e8a\u8bd5\u9a8c\u70b9\u542f\u7528\u540e\uff0c\u62db\u52df\u5de5\u4f5c\u5c06\u6062\u590d\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u91cd\u8981\u7684\u662f\uff0c\u76ee\u524d\u5c1a\u672a\u516c\u5e03\u4efb\u4f55\u7597\u6548\u7ed3\u679c\u3002.<\/strong> \u56e0\u6b64\uff0c\u5bb6\u5ead\u548c\u7814\u7a76\u4eba\u5458\u5e94\u8be5\u5c06 FDA \u6269\u5927\u62db\u52df\u7684\u6388\u6743\u4e0e\u4e34\u5e8a\u7597\u6548\u7684\u8bc1\u636e\u533a\u5206\u5f00\u6765\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9605\u8bfb\u66f4\u591a\uff1a <a href=\"https:\/\/dmdwarrior.com\/clinical-trials\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u63a2\u7d22\u675c\u6c0f\u808c\u8425\u517b\u4e0d\u826f\u75c7\u4e34\u5e8a\u8bd5\u9a8c<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Signature Biologics has announced that the U.S. Food and Drug Administration (FDA) has allowed expanded enrollment in a clinical study evaluating the company\u2019s investigational umbilical cord-derived mesenchymal stem cell (UC-MSC) therapy for Duchenne muscular dystrophy (DMD). The study is being conducted under an Investigational New Drug (IND) application held by the contracted CRO serving as [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":8367,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[303,653,866,259,867],"class_list":["post-8365","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-cell-therapy","tag-ind-application-process","tag-signature-biologics","tag-stem-cell-therapy","tag-uc-msc"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/8365","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/comments?post=8365"}],"version-history":[{"count":4,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/8365\/revisions"}],"predecessor-version":[{"id":8371,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/posts\/8365\/revisions\/8371"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media\/8367"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/media?parent=8365"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/categories?post=8365"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/zh\/wp-json\/wp\/v2\/tags?post=8365"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}