{"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\/fr\/fda-expands-signature-biologics-dmd-study\/","title":{"rendered":"FDA permet d&#039;\u00e9largir le recrutement \u00e0 l&#039;\u00e9tude de th\u00e9rapie cellulaire DMD Signature Biologics."},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Signature Biologics a annonc\u00e9 que la Food and Drug Administration am\u00e9ricaine (FDA) a autoris\u00e9 l&#039;\u00e9largissement des inscriptions \u00e0 une \u00e9tude clinique \u00e9valuant la th\u00e9rapie exp\u00e9rimentale de la soci\u00e9t\u00e9 \u00e0 base de cellules souches m\u00e9senchymateuses d\u00e9riv\u00e9es du cordon ombilical (UC-MSC) pour la dystrophie musculaire de Duchenne (DMD).<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">L\u2019\u00e9tude est men\u00e9e dans le cadre d\u2019une demande d\u2019autorisation de mise sur le march\u00e9 d\u2019un nouveau m\u00e9dicament exp\u00e9rimental (IND) d\u00e9pos\u00e9e par l\u2019organisme de recherche sous contrat (CRO) qui en est le promoteur. La soci\u00e9t\u00e9 Signature Biologics fabrique le produit exp\u00e9rimental et finance l\u2019\u00e9tude.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">La cohorte initiale de cinq participants a termin\u00e9 son recrutement. Cette \u00e9tude ouverte, contr\u00f4l\u00e9e historiquement, comprend des \u00e9valuations fonctionnelles telles que le test de mont\u00e9e de quatre marches, le test de marche de 10 m\u00e8tres et l&#039;\u00e9valuation ambulatoire North Star (NSAA), ainsi que des \u00e9valuations PedsQL DMD et de la fatigue, des analyses m\u00e9taboliques en laboratoire et des bilans de cytokines inflammatoires.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Selon la soci\u00e9t\u00e9, le FDA a permis l&#039;inscription de jusqu&#039;\u00e0 30 participants suppl\u00e9mentaires.<\/strong> Le recrutement reprendra apr\u00e8s l&#039;activation d&#039;un site clinique suppl\u00e9mentaire.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Il est important de noter qu&#039;aucun r\u00e9sultat d&#039;efficacit\u00e9 n&#039;est rapport\u00e9 pour le moment.<\/strong> Les familles et les chercheurs devraient donc faire la distinction entre l&#039;autorisation d&#039;\u00e9largissement du recrutement dans le cadre de l&#039;\u00e9tude FDA et les preuves d&#039;efficacit\u00e9 clinique.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En savoir plus: <a href=\"https:\/\/dmdwarrior.com\/clinical-trials\/\" target=\"_blank\" rel=\"noreferrer noopener\">Explorez les essais cliniques sur la dystrophie musculaire de Duchenne<\/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\/fr\/wp-json\/wp\/v2\/posts\/8365","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/comments?post=8365"}],"version-history":[{"count":4,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/8365\/revisions"}],"predecessor-version":[{"id":8371,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/posts\/8365\/revisions\/8371"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media\/8367"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/media?parent=8365"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/categories?post=8365"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/fr\/wp-json\/wp\/v2\/tags?post=8365"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}