{"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\/pt\/fda-expands-signature-biologics-dmd-study\/","title":{"rendered":"A muta\u00e7\u00e3o FDA permite a expans\u00e3o do recrutamento para o estudo de terapia celular com Signature Biologics para DMD."},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>A Signature Biologics anunciou que a Food and Drug Administration (FDA) dos EUA (FDA) autorizou a expans\u00e3o do recrutamento para um estudo cl\u00ednico que avalia a terapia experimental da empresa com c\u00e9lulas-tronco mesenquimais derivadas do cord\u00e3o umbilical (UC-MSC) para distrofia muscular de Duchenne (DMD).<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">O estudo est\u00e1 sendo conduzido sob uma solicita\u00e7\u00e3o de Novo Medicamento Experimental (IND, na sigla em ingl\u00eas) detida pela CRO contratada que atua como patrocinadora do estudo. A Signature Biologics fabrica o produto experimental e financia o estudo.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">O grupo inicial de cinco participantes concluiu o recrutamento. O estudo aberto, com controle hist\u00f3rico, inclui avalia\u00e7\u00f5es funcionais como o Teste de Subida de 4 Degraus, o Teste de Caminhada de 10 Metros e a Avalia\u00e7\u00e3o Ambulatorial North Star (NSAA), al\u00e9m de avalia\u00e7\u00f5es de DMD (Disfun\u00e7\u00e3o Motora Disfuncional) e fadiga pelo PedsQL (Question\u00e1rio de Qualidade de Vida em Dem\u00eancia) e exames laboratoriais metab\u00f3licos, e pain\u00e9is de citocinas inflamat\u00f3rias.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Segundo a empresa, o modelo FDA permite a inscri\u00e7\u00e3o de at\u00e9 30 participantes adicionais.<\/strong> O recrutamento ser\u00e1 retomado ap\u00f3s a ativa\u00e7\u00e3o de um centro cl\u00ednico adicional.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00c9 importante ressaltar que, neste momento, n\u00e3o h\u00e1 resultados de efic\u00e1cia sendo divulgados.<\/strong> Portanto, fam\u00edlias e pesquisadores devem distinguir a autoriza\u00e7\u00e3o do estudo FDA para expandir o recrutamento de participantes das evid\u00eancias de efic\u00e1cia cl\u00ednica.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Leia mais: <a href=\"https:\/\/dmdwarrior.com\/clinical-trials\/\" target=\"_blank\" rel=\"noreferrer noopener\">Explore os Ensaios Cl\u00ednicos da Distrofia Muscular 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\/pt\/wp-json\/wp\/v2\/posts\/8365","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/comments?post=8365"}],"version-history":[{"count":4,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/8365\/revisions"}],"predecessor-version":[{"id":8371,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/8365\/revisions\/8371"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media\/8367"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media?parent=8365"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/categories?post=8365"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/tags?post=8365"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}