{"id":3112,"date":"2024-12-28T01:57:25","date_gmt":"2024-12-28T00:57:25","guid":{"rendered":"https:\/\/rvh-synergie.org\/actualites\/la-fda-approuve-ryoncil-pour-le-greffon-contre-lhote-aigu-refractaire-aux-steroides-apres-allo-hsct\/"},"modified":"2024-12-28T01:57:27","modified_gmt":"2024-12-28T00:57:27","slug":"la-fda-approuve-ryoncil-pour-le-greffon-contre-lhote-aigu-refractaire-aux-steroides-apres-allo-hsct","status":"publish","type":"post","link":"https:\/\/rvh-synergie.org\/actualites\/la-fda-approuve-ryoncil-pour-le-greffon-contre-lhote-aigu-refractaire-aux-steroides-apres-allo-hsct\/","title":{"rendered":"La FDA approuve Ryoncil pour le greffon contre l&rsquo;h\u00f4te aigu r\u00e9fractaire aux st\u00e9ro\u00efdes apr\u00e8s allo-HSCT"},"content":{"rendered":"<div>\n<div class=\"article-gallery lightGallery\">\n<div data-thumb=\"https:\/\/scx1.b-cdn.net\/csz\/news\/tmb\/2024\/fda-approves-ryoncil-f.jpg\" data-src=\"https:\/\/scx2.b-cdn.net\/gfx\/news\/2024\/fda-approves-ryoncil-f.jpg\" data-sub-html=\"\">\n<figure class=\"article-img\">\n<\/figure><\/div>\n<\/div>\n<p>Le traitement allog\u00e9nique par cellules stromales m\u00e9senchymateuses (CSM) d\u00e9riv\u00e9es de la moelle osseuse Ryoncil (remestemcel-L-rknd) a \u00e9t\u00e9 approuv\u00e9 pour le traitement de la maladie aigu\u00eb du greffon contre l&rsquo;h\u00f4te (SR-aGVHD) r\u00e9fractaire aux st\u00e9ro\u00efdes chez les patients p\u00e9diatriques \u00e2g\u00e9s de 2 mois ou plus. , selon un communiqu\u00e9 de presse de la Food and Drug Administration des \u00c9tats-Unis.<\/p>\n<p>Ryoncil est le premier traitement MSC approuv\u00e9 par la FDA. Les CSM sont isol\u00e9es de la moelle osseuse de donneurs humains adultes en bonne sant\u00e9 et sont utilis\u00e9es pour traiter la SR-aGVHD chez les patients qui subissent une allogreffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques (allo-HSCT).<\/p>\n<p>L&rsquo;innocuit\u00e9 et l&rsquo;efficacit\u00e9 de Ryoncil ont \u00e9t\u00e9 \u00e9valu\u00e9es dans une \u00e9tude multicentrique \u00e0 un seul bras impliquant 54 patients p\u00e9diatriques atteints de SR-aGVHD apr\u00e8s allo-HSCT. Les participants ont re\u00e7u une perfusion intraveineuse de Ryoncil deux fois par semaine pendant quatre semaines. L&rsquo;efficacit\u00e9 de Ryoncil \u00e9tait bas\u00e9e sur le taux et la dur\u00e9e de r\u00e9ponse au traitement apr\u00e8s 28 jours de d\u00e9but. Les participants ayant une r\u00e9ponse partielle ou mixte au traitement ont re\u00e7u des perfusions suppl\u00e9mentaires une fois par semaine pendant quatre semaines. Dans l&rsquo;ensemble, 30 pour cent des participants ont eu une r\u00e9ponse compl\u00e8te au traitement 28 jours apr\u00e8s le d\u00e9but et 41 pour cent ont eu une r\u00e9ponse partielle. Les infections, la fi\u00e8vre, les h\u00e9morragies, les \u0153d\u00e8mes, les douleurs abdominales et l&rsquo;hypertension \u00e9taient les effets ind\u00e9sirables les plus courants chez les participants recevant Ryoncil.<\/p>\n<p>\u00ab\u00a0La d\u00e9cision d&rsquo;aujourd&rsquo;hui marque une \u00e9tape importante dans l&rsquo;utilisation de th\u00e9rapies cellulaires innovantes pour traiter des maladies potentiellement mortelles ayant des impacts d\u00e9vastateurs sur les patients, y compris les enfants\u00a0\u00bb, a d\u00e9clar\u00e9 Peter Marks, MD, Ph.D., directeur du Centre d&rsquo;\u00e9valuation des produits biologiques de la FDA. et Recherche, a d\u00e9clar\u00e9 dans un communiqu\u00e9.<\/p>\n<p>L&rsquo;approbation de Ryoncil a \u00e9t\u00e9 accord\u00e9e \u00e0 Mesoblast.<\/p>\n<p>                                        <!-- print only --><\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Le traitement allog\u00e9nique par cellules stromales m\u00e9senchymateuses (CSM) d\u00e9riv\u00e9es de la moelle osseuse Ryoncil (remestemcel-L-rknd)<\/p>\n","protected":false},"author":1,"featured_media":3113,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[86],"tags":[3273,3274,321,217,171,90,447,967,968,8,969,3272,80],"class_list":["post-3112","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-les-maladies","tag-aigu","tag-allohsct","tag-approuve","tag-apres","tag-aux","tag-contre","tag-fda","tag-greffon","tag-lhote","tag-pour","tag-refractaire","tag-ryoncil","tag-steroides","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-50","resize-featured-image"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - 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