{"id":4267,"date":"2025-01-07T04:28:47","date_gmt":"2025-01-07T04:28:47","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/2025\/08\/18\/fda-approves-first-mesenchymal-stromal-cell-therapy-to-treat-steroid-refractory-acute-graft-versus-host-disease\/"},"modified":"2025-09-29T14:00:13","modified_gmt":"2025-09-29T07:00:13","slug":"fda-chap-thuan-lieu-phap-te-bao-goc-trung-mo-dau-tien-de-dieu-tri-benh-ghep-chong-vat-chu-cap-tinh-khang-steroid","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/fda-chap-thuan-lieu-phap-te-bao-goc-trung-mo-dau-tien-de-dieu-tri-benh-ghep-chong-vat-chu-cap-tinh-khang-steroid\/","title":{"rendered":"FDA Ch\u1ea5p Thu\u1eadn Li\u1ec7u Ph\u00e1p T\u1ebf B\u00e0o G\u1ed1c Trung M\u00f4 \u0110\u1ea7u Ti\u00ean \u0110\u1ec3 \u0110i\u1ec1u Tr\u1ecb B\u1ec7nh Gh\u00e9p Ch\u1ed1ng V\u1eadt Ch\u1ee7 C\u1ea5p T\u00ednh Kh\u00e1ng Steroid"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_80 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">M\u1ee5c l\u1ee5c<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/fda-chap-thuan-lieu-phap-te-bao-goc-trung-mo-dau-tien-de-dieu-tri-benh-ghep-chong-vat-chu-cap-tinh-khang-steroid\/#Tong_quan_ve_benh_ghep_chong_vat_chu_cap_tinh_khang_steroid\" >T\u1ed5ng quan v\u1ec1 b\u1ec7nh gh\u00e9p ch\u1ed1ng v\u1eadt ch\u1ee7 c\u1ea5p t\u00ednh kh\u00e1ng steroid<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/fda-chap-thuan-lieu-phap-te-bao-goc-trung-mo-dau-tien-de-dieu-tri-benh-ghep-chong-vat-chu-cap-tinh-khang-steroid\/#Ho_tro_xay_dung_phong_lab_nuoi_cay_te_bao_goc_trung_mo_MSC\" >H\u1ed7 tr\u1ee3 x\u00e2y d\u1ef1ng ph\u00f2ng lab nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 (MSC)<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"Tong_quan_ve_benh_ghep_chong_vat_chu_cap_tinh_khang_steroid\"><\/span><strong>T\u1ed5ng quan v\u1ec1 b\u1ec7nh gh\u00e9p ch\u1ed1ng v\u1eadt ch\u1ee7 c\u1ea5p t\u00ednh kh\u00e1ng steroid<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>B\u1ec7nh gh\u00e9p ch\u1ed1ng v\u1eadt ch\u1ee7 c\u1ea5p t\u00ednh kh\u00e1ng steroid l\u00e0 t\u00ecnh tr\u1ea1ng nghi\u00eam tr\u1ecdng v\u00e0 \u0111e d\u1ecda t\u00ednh m\u1ea1ng c\u00f3 th\u1ec3 x\u1ea3y ra nh\u01b0 m\u1ed9t bi\u1ebfn ch\u1ee9ng c\u1ee7a gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ea1o m\u00e1u (m\u00e1u) \u0111\u1ed3ng lo\u1ea1i (allo-HSCT). Trong allo-HSCT, b\u1ec7nh nh\u00e2n nh\u1eadn t\u1ebf b\u00e0o g\u1ed1c t\u1ea1o m\u00e1u t\u1eeb ng\u01b0\u1eddi hi\u1ebfn t\u1eb7ng kh\u1ecfe m\u1ea1nh \u0111\u1ec3 thay th\u1ebf t\u1ebf b\u00e0o g\u1ed1c c\u1ee7a ch\u00ednh h\u1ecd v\u00e0 t\u1ea1o ra c\u00e1c t\u1ebf b\u00e0o m\u00e1u m\u1edbi, m\u1ed9t th\u1ee7 thu\u1eadt th\u01b0\u1eddng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n nh\u01b0 m\u1ed9t ph\u1ea7n c\u1ee7a qu\u00e1 tr\u00ecnh \u0111i\u1ec1u tr\u1ecb m\u1ed9t s\u1ed1 lo\u1ea1i ung th\u01b0 m\u00e1u, r\u1ed1i lo\u1ea1n m\u00e1u ho\u1eb7c r\u1ed1i lo\u1ea1n h\u1ec7 th\u1ed1ng mi\u1ec5n d\u1ecbch.<\/p>\n<p>\u201cB\u1ec7nh gh\u00e9p ch\u1ed1ng v\u1eadt ch\u1ee7 c\u1ea5p t\u00ednh kh\u00e1ng steroid c\u00f3 th\u1ec3 g\u00e2y ra h\u1eadu qu\u1ea3 \u0111\u00e1ng k\u1ec3, r\u1ed9ng kh\u1eafp v\u1ec1 s\u1ee9c kh\u1ecfe, bao g\u1ed3m t\u1ed5n th\u01b0\u01a1ng nhi\u1ec1u c\u01a1 quan, gi\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng cu\u1ed9c s\u1ed1ng v\u00e0 nguy c\u01a1 t\u1eed vong \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n b\u1ecb \u1ea3nh h\u01b0\u1edfng\u201d, Nicole Verdun, Ti\u1ebfn s\u0129 Y khoa, gi\u00e1m \u0111\u1ed1c V\u0103n ph\u00f2ng S\u1ea3n ph\u1ea9m Tr\u1ecb li\u1ec7u t\u1ea1i CBER cho bi\u1ebft. \u201cFDA v\u1eabn t\u1eadn t\u1ee5y gi\u00fap gi\u1ea3i quy\u1ebft c\u00e1c nhu c\u1ea7u c\u1ea5p thi\u1ebft ch\u01b0a \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng c\u1ee7a nh\u1eefng c\u00e1 nh\u00e2n m\u1eafc c\u00e1c b\u1ec7nh suy nh\u01b0\u1ee3c v\u00e0 t\u1eed vong, v\u00e0 vi\u1ec7c ph\u00ea duy\u1ec7t ng\u00e0y h\u00f4m nay l\u00e0 m\u1ed9t b\u01b0\u1edbc quan tr\u1ecdng trong n\u1ed7 l\u1ef1c \u0111\u00f3\u201d.<\/p>\n<p>\u201cCh\u00fang t\u00f4i r\u1ea5t vui khi FDA ch\u1ea5p nh\u1eadn \u0111\u01a1n xin c\u1ea5p l\u1ea1i BLA c\u1ee7a ch\u00fang t\u00f4i \u0111\u1ec3 xem x\u00e9t v\u00e0 mong ch\u1edd kh\u1ea3 n\u0103ng ph\u00ea duy\u1ec7t RYONCIL cho tr\u1ebb em m\u1eafc SR-aGVHD\u201d, Ti\u1ebfn s\u0129 Silviu Itescu, T\u1ed5ng gi\u00e1m \u0111\u1ed1c \u0111i\u1ec1u h\u00e0nh c\u1ee7a Mesoblast Limited cho bi\u1ebft.<\/p>\n<p>FDA ch\u1ea5p nh\u1eadn \u0111\u01a1n xin c\u1ea5p ph\u00e9p thu\u1ed1c sinh h\u1ecdc (BLA) c\u1ee7a Mesoblast cho Ryoncil\u00ae \u1edf tr\u1ebb em m\u1eafc b\u1ec7nh gh\u00e9p ch\u1ed1ng v\u1eadt ch\u1ee7 c\u1ea5p t\u00ednh kh\u00e1ng steroid (SR-aGVHD)<\/p>\n<p>\u0110\u1ecdc ti\u1ebfp th\u00f4ng tin t\u1ea1i <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host\">link FDA<\/a><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Ho_tro_xay_dung_phong_lab_nuoi_cay_te_bao_goc_trung_mo_MSC\"><\/span><strong>H\u1ed7 tr\u1ee3 x\u00e2y d\u1ef1ng ph\u00f2ng lab nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 (MSC)<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u0110\u1ec3 s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o MSC, c\u1ea7n th\u1ef1c hi\u1ec7n c\u00e1c b\u01b0\u1edbc ch\u00ednh: thu th\u1eadp v\u00e0 x\u1eed l\u00fd m\u1eabu t\u1eeb c\u00e1c ngu\u1ed3n nh\u01b0 t\u1ee7y x\u01b0\u01a1ng, m\u00f4 m\u1ee1 ho\u1eb7c d\u00e2y r\u1ed1n; nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o trong m\u00f4i tr\u01b0\u1eddng ph\u00f9 h\u1ee3p; t\u0103ng sinh s\u1ed1 l\u01b0\u1ee3ng t\u1ebf b\u00e0o; ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng (marker, vi sinh, kh\u1ea3 n\u0103ng bi\u1ec7t h\u00f3a); v\u00e0 b\u1ea3o qu\u1ea3n \u0111\u00f4ng l\u1ea1nh trong \u0111i\u1ec1u ki\u1ec7n an to\u00e0n. Qu\u00e1 tr\u00ecnh n\u00e0y \u0111\u00f2i h\u1ecfi m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y chuy\u00ean d\u1ee5ng v\u00e0 c\u00e1c thi\u1ebft b\u1ecb hi\u1ec7n \u0111\u1ea1i.<\/p>\n<p>Biogroup h\u00e2n h\u1ea1nh gi\u1edbi thi\u1ec7u <a href=\"https:\/\/biogroupvietnam.com\/vi\/products\/nuoi-cay-te-bao\/te-bao-goc-trung-mo\/cellcor-cd-msc.html\"><strong>CellCor CD MSC AOF<\/strong><\/a> t\u1eeb Xcell Therapeutics \u2013 m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y th\u1ebf h\u1ec7 th\u1ee9 3, \u0111\u1ea1t ti\u00eau chu\u1ea9n <strong>Animal Origin Free (AOF)<\/strong>, \u0111\u1ea3m b\u1ea3o an to\u00e0n v\u00e0 t\u1ed1i \u01b0u cho s\u1ea3n xu\u1ea5t MSCs. V\u1edbi c\u00f4ng th\u1ee9c ti\u00ean ti\u1ebfn, CellCor CD MSC AOF h\u1ed7 tr\u1ee3 t\u0103ng tr\u01b0\u1edfng v\u00e0 m\u1edf r\u1ed9ng t\u1ebf b\u00e0o hi\u1ec7u qu\u1ea3 m\u00e0 kh\u00f4ng ti\u1ebfp x\u00fac b\u1ea5t k\u1ef3 th\u00e0nh ph\u1ea7n n\u00e0o t\u1eeb \u0111\u1ed9ng v\u1eadt.<\/p>\n<p>Ngo\u00e0i ra, Biogroup cung c\u1ea5p \u0111\u1ea7y \u0111\u1ee7 thi\u1ebft b\u1ecb v\u00e0 v\u1eadt t\u01b0 h\u1ed7 tr\u1ee3 nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o, bao g\u1ed3m:<\/p>\n<ul>\n<li><strong>T\u1ee7 an to\u00e0n sinh h\u1ecdc<\/strong>, <strong>t\u1ee7 \u1ea5m CO2<\/strong>, <strong>m\u00e1y ly t\u00e2m<\/strong>, <strong>m\u00e1y \u0111\u1ebfm t\u1ebf b\u00e0o<\/strong>, \u2026<\/li>\n<li><strong>B\u00ecnh nu\u00f4i c\u1ea5y<\/strong>, <strong>\u0111\u0129a nu\u00f4i c\u1ea5y<\/strong>, <strong>\u1ed1ng ly t\u00e2m<\/strong> v\u00e0 c\u00e1c gi\u1ea3i ph\u00e1p t\u1ed1i \u01b0u kh\u00e1c.<\/li>\n<\/ul>\n<p>H\u00e3y li\u00ean h\u1ec7 v\u1edbi ch\u00fang t\u00f4i \u0111\u1ec3 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n chi ti\u1ebft.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>T\u1ed5ng quan v\u1ec1 b\u1ec7nh gh\u00e9p ch\u1ed1ng v\u1eadt ch\u1ee7 c\u1ea5p t\u00ednh kh\u00e1ng steroid B\u1ec7nh gh\u00e9p ch\u1ed1ng v\u1eadt ch\u1ee7 c\u1ea5p t\u00ednh kh\u00e1ng steroid l\u00e0 t\u00ecnh tr\u1ea1ng nghi\u00eam tr\u1ecdng v\u00e0 \u0111e d\u1ecda t\u00ednh m\u1ea1ng c\u00f3 th\u1ec3 x\u1ea3y ra nh\u01b0 m\u1ed9t bi\u1ebfn ch\u1ee9ng c\u1ee7a gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ea1o m\u00e1u (m\u00e1u) \u0111\u1ed3ng lo\u1ea1i (allo-HSCT). Trong allo-HSCT, b\u1ec7nh nh\u00e2n nh\u1eadn<\/p>\n<div class=\"klb-readmore post-buttons\"><a class=\"button rounded primary\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/fda-chap-thuan-lieu-phap-te-bao-goc-trung-mo-dau-tien-de-dieu-tri-benh-ghep-chong-vat-chu-cap-tinh-khang-steroid\/\">Read More <i class=\"klbth-icon-right-arrow\"><\/i><\/a><\/div>\n","protected":false},"author":1,"featured_media":5736,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[19],"tags":[],"class_list":["post-4267","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Ch\u1ea5p Thu\u1eadn Li\u1ec7u Ph\u00e1p T\u1ebf B\u00e0o G\u1ed1c Trung M\u00f4 \u0110\u1ea7u Ti\u00ean \u0110\u1ec3 \u0110i\u1ec1u Tr\u1ecb B\u1ec7nh Gh\u00e9p Ch\u1ed1ng V\u1eadt Ch\u1ee7 C\u1ea5p T\u00ednh Kh\u00e1ng Steroid<\/title>\n<meta name=\"description\" content=\"B\u1ec7nh gh\u00e9p ch\u1ed1ng v\u1eadt ch\u1ee7 c\u1ea5p t\u00ednh kh\u00e1ng steroid l\u00e0 t\u00ecnh tr\u1ea1ng nghi\u00eam tr\u1ecdng v\u00e0 \u0111e d\u1ecda t\u00ednh m\u1ea1ng c\u00f3 th\u1ec3 x\u1ea3y ra nh\u01b0 m\u1ed9t bi\u1ebfn ch\u1ee9ng c\u1ee7a gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ea1o m\u00e1u (m\u00e1u) \u0111\u1ed3ng lo\u1ea1i (allo-HSCT).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/fda-chap-thuan-lieu-phap-te-bao-goc-trung-mo-dau-tien-de-dieu-tri-benh-ghep-chong-vat-chu-cap-tinh-khang-steroid\/\" \/>\n<meta property=\"og:locale\" content=\"vi_VN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Ch\u1ea5p Thu\u1eadn Li\u1ec7u Ph\u00e1p T\u1ebf B\u00e0o G\u1ed1c Trung M\u00f4 \u0110\u1ea7u Ti\u00ean \u0110\u1ec3 \u0110i\u1ec1u Tr\u1ecb B\u1ec7nh Gh\u00e9p Ch\u1ed1ng V\u1eadt Ch\u1ee7 C\u1ea5p T\u00ednh Kh\u00e1ng Steroid\" \/>\n<meta property=\"og:description\" content=\"B\u1ec7nh gh\u00e9p ch\u1ed1ng v\u1eadt ch\u1ee7 c\u1ea5p t\u00ednh kh\u00e1ng steroid l\u00e0 t\u00ecnh tr\u1ea1ng nghi\u00eam tr\u1ecdng v\u00e0 \u0111e d\u1ecda t\u00ednh m\u1ea1ng c\u00f3 th\u1ec3 x\u1ea3y ra nh\u01b0 m\u1ed9t bi\u1ebfn ch\u1ee9ng c\u1ee7a gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ea1o m\u00e1u (m\u00e1u) \u0111\u1ed3ng lo\u1ea1i (allo-HSCT).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/fda-chap-thuan-lieu-phap-te-bao-goc-trung-mo-dau-tien-de-dieu-tri-benh-ghep-chong-vat-chu-cap-tinh-khang-steroid\/\" \/>\n<meta property=\"og:site_name\" content=\"Biogroup Vietnam\" \/>\n<meta property=\"article:published_time\" content=\"2025-01-07T04:28:47+00:00\" \/>\n<meta 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