{"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\/tr\/fda-expands-signature-biologics-dmd-study\/","title":{"rendered":"FDA, Signature Biologics'in DMD H\u00fccre Tedavisi \u00c7al\u0131\u015fmas\u0131na Kat\u0131l\u0131m\u0131 Geni\u015fletmeye Olanak Sa\u011fl\u0131yor"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Signature Biologics, ABD G\u0131da ve \u0130la\u00e7 \u0130daresi&#039;nin (FDA), \u015firketin Duchenne kas distrofisi (DMD) i\u00e7in geli\u015ftirdi\u011fi g\u00f6bek kordonundan elde edilen mezenkimal k\u00f6k h\u00fccre (UC-MSC) tedavisini de\u011ferlendiren klinik \u00e7al\u0131\u015fmaya geni\u015fletilmi\u015f kay\u0131t izni verdi\u011fini duyurdu.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu \u00e7al\u0131\u015fma, \u00e7al\u0131\u015fma sponsoru olarak g\u00f6rev yapan s\u00f6zle\u015fmeli ara\u015ft\u0131rma kurulu\u015fu (CRO) taraf\u0131ndan y\u00fcr\u00fct\u00fclen bir Ara\u015ft\u0131rma Ama\u00e7l\u0131 Yeni \u0130la\u00e7 (IND) ba\u015fvurusu kapsam\u0131nda ger\u00e7ekle\u015ftirilmektedir. Signature Biologics, ara\u015ft\u0131rma \u00fcr\u00fcn\u00fcn\u00fc \u00fcretmekte ve \u00e7al\u0131\u015fmay\u0131 finanse etmektedir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Be\u015f kat\u0131l\u0131mc\u0131dan olu\u015fan ilk grup kay\u0131t i\u015flemini tamamlad\u0131. A\u00e7\u0131k etiketli, tarihsel olarak kontroll\u00fc \u00e7al\u0131\u015fma, 4 Basamakl\u0131 Merdiven T\u0131rmanma Testi, 10 Metre Y\u00fcr\u00fcme Testi ve North Star Ambulatuvar De\u011ferlendirmesi (NSAA) gibi fonksiyonel de\u011ferlendirmelerin yan\u0131 s\u0131ra PedsQL DMD ve yorgunluk de\u011ferlendirmeleri, metabolik laboratuvar testleri ve inflamatuar sitokin panellerini i\u00e7ermektedir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u015eirketin a\u00e7\u0131klamas\u0131na g\u00f6re, FDA modeli 30&#039;a kadar ek kat\u0131l\u0131mc\u0131n\u0131n kayd\u0131na izin vermektedir.<\/strong> Ek bir klinik merkez faaliyete ge\u00e7tikten sonra kat\u0131l\u0131mc\u0131 almaya yeniden ba\u015flayacakt\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6nemli bir nokta olarak, \u015fu anda herhangi bir etkinlik sonucu bildirilmemektedir.<\/strong> Bu nedenle aileler ve ara\u015ft\u0131rmac\u0131lar, FDA'n\u0131n kay\u0131t say\u0131s\u0131n\u0131 geni\u015fletme iznini klinik etkinli\u011fe dair kan\u0131tlardan ay\u0131rt etmelidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Devam\u0131n\u0131 oku: <a href=\"https:\/\/dmdwarrior.com\/clinical-trials\/\" target=\"_blank\" rel=\"noreferrer noopener\">Duchenne Klinik Ara\u015ft\u0131rmalar\u0131n\u0131 Ke\u015ffedin<\/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\/tr\/wp-json\/wp\/v2\/posts\/8365","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/comments?post=8365"}],"version-history":[{"count":4,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/8365\/revisions"}],"predecessor-version":[{"id":8371,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/8365\/revisions\/8371"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/8367"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=8365"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=8365"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=8365"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}