{"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\/es\/fda-expands-signature-biologics-dmd-study\/","title":{"rendered":"FDA permite ampliar la inscripci\u00f3n en el estudio de terapia celular Signature Biologics para la distrofia muscular de Duchenne."},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Signature Biologics ha anunciado que la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) ha autorizado la ampliaci\u00f3n de la inscripci\u00f3n en un estudio cl\u00ednico que eval\u00faa la terapia experimental de la compa\u00f1\u00eda con c\u00e9lulas madre mesenquimales derivadas del cord\u00f3n umbilical (UC-MSC) para la distrofia muscular de Duchenne (DMD).<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">El estudio se est\u00e1 llevando a cabo bajo una solicitud de nuevo f\u00e1rmaco en investigaci\u00f3n (IND, por sus siglas en ingl\u00e9s) presentada por la CRO contratada que act\u00faa como patrocinadora del estudio. Signature Biologics fabrica el producto en investigaci\u00f3n y financia el estudio.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">El grupo inicial de cinco participantes ha completado su inscripci\u00f3n. El estudio abierto, con control hist\u00f3rico, incluye evaluaciones funcionales como la prueba de subir 4 escalones, la prueba de marcha de 10 metros y la evaluaci\u00f3n ambulatoria North Star (NSAA), as\u00ed como evaluaciones PedsQL DMD y de fatiga, an\u00e1lisis de laboratorio metab\u00f3licos y paneles de citocinas inflamatorias.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Seg\u00fan la empresa, el modelo FDA permite la inscripci\u00f3n de hasta 30 participantes adicionales.<\/strong> El proceso de reclutamiento se reanudar\u00e1 una vez que se active un centro cl\u00ednico adicional.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Es importante destacar que, por el momento, no se est\u00e1n publicando resultados de eficacia.<\/strong> Por lo tanto, las familias y los investigadores deben distinguir la autorizaci\u00f3n del estudio FDA para ampliar la inscripci\u00f3n de participantes de la evidencia de su eficacia cl\u00ednica.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Leer m\u00e1s: <a href=\"https:\/\/dmdwarrior.com\/clinical-trials\/\" target=\"_blank\" rel=\"noreferrer noopener\">Explora los ensayos cl\u00ednicos sobre la 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\/es\/wp-json\/wp\/v2\/posts\/8365","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/comments?post=8365"}],"version-history":[{"count":4,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/8365\/revisions"}],"predecessor-version":[{"id":8371,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/8365\/revisions\/8371"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media\/8367"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media?parent=8365"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/categories?post=8365"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/tags?post=8365"}],"curies":[{"name":"gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}