{"id":32552,"date":"2025-02-18T09:03:47","date_gmt":"2025-02-18T08:03:47","guid":{"rendered":"https:\/\/dupmecp2.eu\/?p=32552"},"modified":"2025-02-18T10:46:39","modified_gmt":"2025-02-18T09:46:39","slug":"reclutamiento-de-heroes","status":"publish","type":"post","link":"https:\/\/dupmecp2.eu\/es\/reclutamiento-de-heroes\/","title":{"rendered":"Comienza el reclutamiento para el ensayo cl\u00ednico HERO: CRISPR cas13 para el s\u00edndrome"},"content":{"rendered":"<p><strong>El ensayo cl\u00ednico HERO es un estudio pionero que eval\u00faa HG204, una nueva terapia de edici\u00f3n de ARN CRISPR Cas13, para el s\u00edndrome de duplicaci\u00f3n MECP2 (SMD). Patrocinado por HuidaGene, este ensayo marca un hito importante en la b\u00fasqueda de un tratamiento para el s\u00edndrome. En noviembre de 2024, el primer paciente recibi\u00f3 con \u00e9xito el HG204, ofreciendo nuevas esperanzas a la comunidad.  <\/strong> <\/p>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/dupmecp2.eu\/es\/crispr-cas13-une-technologie-revolutionnaire-a-haut-potentiel\/?lang=fr\" style=\"border-radius:10px;background-color:#f7a13f\" target=\"_blank\" rel=\"noreferrer noopener\">Todo sobre la tecnolog\u00eda<\/a><\/div>\n<\/div>\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p><strong>Resumen del ensayo<\/strong> <\/p>\n\n<p>El ensayo HERO consiste en una \u00fanica inyecci\u00f3n intracerebroventricular de HG204, lo que permite administrar el tratamiento directamente en el cerebro. El reclutamiento para el ensayo comenz\u00f3 en octubre de 2024, y el objetivo del estudio es reclutar a seis participantes varones, de entre 2 y 18 a\u00f1os de edad, con un diagn\u00f3stico confirmado de s\u00edndrome de duplicaci\u00f3n de MECP2. Cada participante tomar\u00e1 parte en un ensayo de 60 semanas, que comprende un periodo de cribado de 8 semanas, la administraci\u00f3n del tratamiento y una fase de seguimiento de 52 semanas. Los objetivos principales son controlar los acontecimientos adversos y evaluar el progreso del desarrollo tras el tratamiento. El ensayo se est\u00e1 realizando actualmente en el Hospital Universitario de Pek\u00edn (China). El reclutamiento de m\u00e1s pacientes en China depender\u00e1 de los resultados de los primeros pacientes tratados en el ensayo.      <\/p>\n\n<p>Para m\u00e1s informaci\u00f3n, lea el protocolo del estudio.<\/p>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/clinicaltrials.gov\/study\/NCT06615206?cond=Mecp2%20Duplication%20Syndrome&amp;rank=1\" style=\"border-radius:10px;background-color:#f7a13f\" target=\"_blank\" rel=\"noreferrer noopener\">Ver el protocolo del estudio<\/a><\/div>\n<\/div>\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p><strong>Primer paciente tratado y resultados preliminares<\/strong> <\/p>\n\n<p>En noviembre, HuidaGene anunci\u00f3 que el HG204 se hab\u00eda administrado con \u00e9xito al primer paciente. Seis semanas despu\u00e9s de la inyecci\u00f3n, el paciente no mostraba efectos secundarios importantes y se observaron signos preliminares de eficacia. En las pr\u00f3ximas semanas se seguir\u00e1 de cerca al paciente para evaluar con m\u00e1s detalle la seguridad y eficacia del tratamiento.   <\/p>\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p><strong>Pr\u00f3ximos pasos y objetivos<\/strong> <\/p>\n\n<p>HuidaGene ha realizado avances normativos al obtener dos importantes designaciones de la FDA: la Designaci\u00f3n de Enfermedad Pedi\u00e1trica Rara (RPDD) y la Designaci\u00f3n de Medicamento Hu\u00e9rfano (ODD) para el HG204 en el tratamiento del s\u00edndrome de duplicaci\u00f3n del gen MECP2. Aunque HERO se est\u00e1 llevando a cabo en China, la empresa biotecnol\u00f3gica tambi\u00e9n est\u00e1 en conversaciones con la FDA y la EMA para estudiar la posibilidad de realizar m\u00e1s estudios en EE.UU. y Europa.  <\/p>\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p><strong>Publicaci\u00f3n de investigaciones<\/strong> <\/p>\n\n<p>Mientras tanto, HuidaGene ha publicado en Nature Neuroscience detalles de los resultados experimentales precl\u00ednicos de la tecnolog\u00eda. <em>CRISPR-Cas13, <\/em>incluido el HG204. Los estudios han demostrado que el HG204 reduce eficazmente los niveles de ARNm de MECP2, alivia los s\u00edntomas de la enfermedad y prolonga la vida en modelos de rat\u00f3n y primates no humanos sin causar efectos adversos. Estos resultados refuerzan la legitimidad del ensayo cl\u00ednico en curso y el potencial del HG204 como opci\u00f3n terap\u00e9utica para el s\u00edndrome.   <\/p>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/www.nature.com\/articles\/s41593-024-01838-6\" style=\"border-radius:10px;background-color:#f7a13f\" target=\"_blank\" rel=\"noreferrer noopener\">Ver la publicaci\u00f3n<\/a><\/div>\n<\/div>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>El ensayo cl\u00ednico HERO representa un hito importante en la b\u00fasqueda de un tratamiento para el s\u00edndrome de duplicaci\u00f3n del gen MECP2. La combinaci\u00f3n de la tecnolog\u00eda CRISPR cas13 de vanguardia y los prometedores resultados preliminares da esperanzas a los pacientes y familias afectados por este s\u00edndrome. En los pr\u00f3ximos meses, el seguimiento ser\u00e1 esencial para verificar plenamente la seguridad y eficacia del HG204 en el tratamiento del s\u00edndrome de duplicaci\u00f3n del gen MECP2.   <\/p>\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>L&rsquo;essai clinique HERO est une \u00e9tude pionni\u00e8re \u00e9valuant le HG204, une nouvelle th\u00e9rapie CRISPR Cas13 d&rsquo;\u00e9dition de l&rsquo;ARN, pour le syndrome de duplication MECP2 (MDS). Sponsoris\u00e9 par HuidaGene, cet essai [&hellip;]<\/p>","protected":false},"author":1,"featured_media":32702,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-32552","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualite"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>D\u00e9but du recrutement pour l&#039;essai clinique HERO : CRISPR cas13 pour le syndrome - DupMECP2<\/title>\n<meta name=\"description\" content=\"L&#039;essai clinique HERO repr\u00e9sente une \u00e9tape importante dans la recherche d&#039;un traitement pour le syndrome de duplication du g\u00e8ne MECP2. 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