{"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":"rekrutacja-bohaterow","status":"publish","type":"post","link":"https:\/\/dupmecp2.eu\/pl\/rekrutacja-bohaterow\/","title":{"rendered":"Rozpocz\u0119cie rekrutacji do badania klinicznego HERO: CRISPR cas13 dla zespo\u0142u"},"content":{"rendered":"<p><strong>Badanie kliniczne HERO jest pionierskim badaniem oceniaj\u0105cym HG204, now\u0105 terapi\u0119 CRISPR Cas13 RNA, w leczeniu zespo\u0142u duplikacji MECP2 (MDS). Sponsorowane przez HuidaGene, badanie to stanowi wa\u017cny kamie\u0144 milowy w poszukiwaniu leczenia tego zespo\u0142u. W listopadzie 2024 r. pierwszy pacjent z powodzeniem otrzyma\u0142 HG204, daj\u0105c spo\u0142eczno\u015bci now\u0105 nadziej\u0119.  <\/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\/pl\/crispr-cas13-une-technologie-revolutionnaire-a-haut-potentiel\/?lang=fr\" style=\"border-radius:10px;background-color:#f7a13f\" target=\"_blank\" rel=\"noreferrer noopener\">Wszystko o technologii<\/a><\/div>\n<\/div>\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p><strong>Przegl\u0105d badania<\/strong> <\/p>\n\n<p>Badanie HERO obejmuje pojedyncze wstrzykni\u0119cie dokomorowe HG204, co pozwala na dostarczenie leku bezpo\u015brednio do m\u00f3zgu. Rekrutacja do badania rozpocz\u0119\u0142a si\u0119 w pa\u017adzierniku 2024 r., a badanie ma na celu rekrutacj\u0119 sze\u015bciu uczestnik\u00f3w p\u0142ci m\u0119skiej w wieku od 2 do 18 lat z potwierdzon\u0105 diagnoz\u0105 zespo\u0142u duplikacji MECP2. Ka\u017cdy uczestnik we\u017amie udzia\u0142 w 60-tygodniowym badaniu, obejmuj\u0105cym 8-tygodniowy okres przesiewowy, podawanie leczenia i 52-tygodniow\u0105 faz\u0119 obserwacji. G\u0142\u00f3wnymi celami s\u0105 monitorowanie zdarze\u0144 niepo\u017c\u0105danych i ocena post\u0119p\u00f3w rozwojowych po leczeniu. Badanie jest obecnie prowadzone w Szpitalu Uniwersyteckim w Pekinie w Chinach. Rekrutacja dodatkowych pacjent\u00f3w w Chinach b\u0119dzie zale\u017ce\u0107 od wynik\u00f3w pierwszych pacjent\u00f3w leczonych w ramach badania.      <\/p>\n\n<p>Wi\u0119cej informacji mo\u017cna znale\u017a\u0107 w protokole badania.<\/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\">Zobacz protok\u00f3\u0142 badania<\/a><\/div>\n<\/div>\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p><strong>Pierwszy leczony pacjent i wst\u0119pne wyniki<\/strong> <\/p>\n\n<p>W listopadzie HuidaGene og\u0142osi\u0142a, \u017ce HG204 zosta\u0142 z powodzeniem podany pierwszemu pacjentowi. Sze\u015b\u0107 tygodni po wstrzykni\u0119ciu pacjent nie wykazywa\u0142 \u017cadnych powa\u017cnych skutk\u00f3w ubocznych i zaobserwowano wst\u0119pne oznaki skuteczno\u015bci. W nadchodz\u0105cych tygodniach pacjent b\u0119dzie \u015bci\u015ble monitorowany w celu bardziej szczeg\u00f3\u0142owej oceny bezpiecze\u0144stwa i skuteczno\u015bci leczenia.   <\/p>\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p><strong>Kolejne kroki i cele<\/strong> <\/p>\n\n<p>HuidaGene poczyni\u0142a post\u0119py regulacyjne, uzyskuj\u0105c dwa wa\u017cne oznaczenia od FDA: Rare Pediatric Disease Designation (RPDD) i Orphan Drug Designation (ODD) dla HG204 w leczeniu zespo\u0142u duplikacji genu MECP2. Podczas gdy badanie HERO jest prowadzone w Chinach, firma biotechnologiczna prowadzi r\u00f3wnie\u017c rozmowy z FDA i EMA w celu rozwa\u017cenia dalszych bada\u0144 w USA i Europie.  <\/p>\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p><strong>Publikacja bada\u0144<\/strong> <\/p>\n\n<p>W mi\u0119dzyczasie HuidaGene opublikowa\u0142a szczeg\u00f3\u0142y przedklinicznych wynik\u00f3w eksperymentalnych dla tej technologii w Nature Neuroscience. <em>CRISPR-Cas13, <\/em>w tym HG204. Badania wykaza\u0142y, \u017ce HG204 skutecznie obni\u017ca poziom mRNA MECP2, \u0142agodzi objawy choroby i przed\u0142u\u017ca \u017cycie w modelach mysich i naczelnych bez wywo\u0142ywania dzia\u0142a\u0144 niepo\u017c\u0105danych. Wyniki te potwierdzaj\u0105 zasadno\u015b\u0107 trwaj\u0105cego badania klinicznego i potencja\u0142 HG204 jako opcji terapeutycznej dla tego zespo\u0142u.   <\/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\">Zobacz publikacj\u0119<\/a><\/div>\n<\/div>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>Badanie kliniczne HERO stanowi wa\u017cny kamie\u0144 milowy w poszukiwaniu leczenia zespo\u0142u duplikacji genu MECP2. Po\u0142\u0105czenie najnowocze\u015bniejszej technologii CRISPR cas13 i obiecuj\u0105cych wst\u0119pnych wynik\u00f3w daje nadziej\u0119 pacjentom i rodzinom dotkni\u0119tym tym zespo\u0142em. W nadchodz\u0105cych miesi\u0105cach monitorowanie b\u0119dzie niezb\u0119dne do pe\u0142nej weryfikacji bezpiecze\u0144stwa i skuteczno\u015bci HG204 w leczeniu zespo\u0142u duplikacji genu 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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