{"id":2067,"date":"2025-06-23T13:58:28","date_gmt":"2025-06-23T06:58:28","guid":{"rendered":"https:\/\/biomedmart.com.vn\/?p=2067"},"modified":"2025-06-23T13:59:07","modified_gmt":"2025-06-23T06:59:07","slug":"fda-phe-duyet-lieu-phap-te-bao-goc-trung-mo-dau-tien-dieu-tri-benh-ghep-chong-vat-chu-cap-tinh-khang-steroid","status":"publish","type":"post","link":"https:\/\/biomedmart.com.vn\/etc\/2025\/06\/23\/fda-phe-duyet-lieu-phap-te-bao-goc-trung-mo-dau-tien-dieu-tri-benh-ghep-chong-vat-chu-cap-tinh-khang-steroid\/","title":{"rendered":"FDA Ph\u00ea Duy\u1ec7t Li\u1ec7u Ph\u00e1p T\u1ebf B\u00e0o G\u1ed1c Trung M\u00f4 \u0110\u1ea7u Ti\u00ean \u0110i\u1ec1u Tr\u1ecb V\u1eadt Gh\u00e9p Ch\u1ed1ng K\u00ed Ch\u1ee7 C\u1ea5p T\u00ednh Kh\u00e1ng Steroid"},"content":{"rendered":"\n

Ng\u00e0y 18\/12\/2024 \u2014 Hoa K\u1ef3<\/strong><\/p>\n\n\n\n

\"\"<\/a><\/figure>\n\n\n\n

C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) v\u1eeba ch\u00ednh th\u1ee9c ph\u00ea duy\u1ec7t Ryoncil (remestemcel-L-rknd)<\/strong> \u2014 li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 (MSC) \u0111\u1ea7u ti\u00ean \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p t\u1ea1i M\u1ef9. Ryoncil \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb b\u1ec7nh v\u1eadt gh\u00e9p ch\u1ed1ng k\u00ed ch\u1ee7 c\u1ea5p t\u00ednh kh\u00e1ng steroid (SR-aGVHD)<\/strong> \u1edf tr\u1ebb em t\u1eeb 2 th\u00e1ng tu\u1ed5i tr\u1edf l\u00ean<\/strong>.<\/p>\n\n\n\n

\ud83e\uddec Li\u1ec7u ph\u00e1p MSC \u0111\u1ea7u ti\u00ean \u0111\u01b0\u1ee3c FDA ph\u00ea duy\u1ec7t<\/strong><\/h2>\n\n\n\n

Ryoncil l\u00e0 m\u1ed9t s\u1ea3n ph\u1ea9m ch\u1ee9a t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 (MSC)<\/strong> \u0111\u01b0\u1ee3c ph\u00e2n l\u1eadp t\u1eeb t\u1ee7y x\u01b0\u01a1ng c\u1ee7a ng\u01b0\u1eddi hi\u1ebfn t\u1eb7ng tr\u01b0\u1edfng th\u00e0nh<\/strong>. \u0110\u00e2y l\u00e0 t\u1ebf b\u00e0o c\u00f3 kh\u1ea3 n\u0103ng \u0111i\u1ec1u h\u00f2a mi\u1ec5n d\u1ecbch, ch\u1ed1ng vi\u00eam v\u00e0 h\u1ed7 tr\u1ee3 ph\u1ee5c h\u1ed3i t\u1ed5n th\u01b0\u01a1ng m\u00f4.<\/p>\n\n\n\n

Theo Ti\u1ebfn s\u0129 Peter Marks, Gi\u00e1m \u0111\u1ed1c Trung t\u00e2m \u0110\u00e1nh gi\u00e1 v\u00e0 Nghi\u00ean c\u1ee9u Sinh h\u1ecdc (CBER) c\u1ee7a FDA:<\/p>\n\n\n\n

\n

\u201cPh\u00ea duy\u1ec7t Ryoncil l\u00e0 m\u1ed9t c\u1ed9t m\u1ed1c quan tr\u1ecdng trong h\u00e0nh tr\u00ecnh ph\u00e1t tri\u1ec3n c\u00e1c li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o ti\u00ean ti\u1ebfn cho nh\u1eefng b\u1ec7nh l\u00fd \u0111e d\u1ecda t\u00ednh m\u1ea1ng, \u0111\u1eb7c bi\u1ec7t l\u00e0 \u1edf tr\u1ebb em. FDA cam k\u1ebft h\u1ed7 tr\u1ee3 c\u00e1c s\u1ea3n ph\u1ea9m \u0111i\u1ec1u tr\u1ecb m\u1edbi, an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 \u0111\u1ec3 c\u1ea3i thi\u1ec7n ch\u1ea5t l\u01b0\u1ee3ng cu\u1ed9c s\u1ed1ng cho b\u1ec7nh nh\u00e2n.\u201d<\/p>\n<\/blockquote>\n\n\n\n

SR-aGVHD \u2013 Bi\u1ebfn ch\u1ee9ng nghi\u00eam tr\u1ecdng sau gh\u00e9p t\u1ebf b\u00e0o t\u1ea1o m\u00e1u<\/strong><\/h2>\n\n\n\n

SR-aGVHD l\u00e0 m\u1ed9t bi\u1ebfn ch\u1ee9ng nghi\u00eam tr\u1ecdng sau gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ea1o m\u00e1u \u0111\u1ed3ng lo\u00e0i (allo-HSCT)<\/strong>, th\u01b0\u1eddng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u1edf b\u1ec7nh nh\u00e2n ung th\u01b0 m\u00e1u ho\u1eb7c r\u1ed1i lo\u1ea1n h\u1ec7 mi\u1ec5n d\u1ecbch. Khi x\u1ea3y ra, h\u1ec7 mi\u1ec5n d\u1ecbch m\u1edbi c\u1ee7a ng\u01b0\u1eddi nh\u1eadn t\u1ea5n c\u00f4ng c\u00e1c c\u01a1 quan c\u1ee7a ch\u00ednh h\u1ecd, d\u1eabn \u0111\u1ebfn t\u1ed5n th\u01b0\u01a1ng \u0111a c\u01a1 quan, gi\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng s\u1ed1ng v\u00e0 nguy c\u01a1 t\u1eed vong cao<\/strong> \u2014 \u0111\u1eb7c bi\u1ec7t n\u1ebfu kh\u00f4ng \u0111\u00e1p \u1ee9ng v\u1edbi corticosteroid.<\/p>\n\n\n\n

Ti\u1ebfn s\u0129 Nicole Verdun, Gi\u00e1m \u0111\u1ed1c V\u0103n ph\u00f2ng S\u1ea3n ph\u1ea9m Tr\u1ecb li\u1ec7u t\u1ea1i CBER cho bi\u1ebft:<\/p>\n\n\n\n

\n

\u201cSR-aGVHD g\u00e2y h\u1eadu qu\u1ea3 n\u1eb7ng n\u1ec1 tr\u00ean nhi\u1ec1u c\u01a1 quan. Vi\u1ec7c c\u00f3 th\u00eam m\u1ed9t l\u1ef1a ch\u1ecdn \u0111i\u1ec1u tr\u1ecb nh\u01b0 Ryoncil l\u00e0 b\u01b0\u1edbc ti\u1ebfn \u0111\u00e1ng k\u1ec3 trong vi\u1ec7c gi\u1ea3i quy\u1ebft nhu c\u1ea7u y t\u1ebf ch\u01b0a \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng.\u201d<\/p>\n<\/blockquote>\n\n\n\n

\ud83d\udd2c Hi\u1ec7u qu\u1ea3 v\u00e0 an to\u00e0n c\u1ee7a Ryoncil<\/strong><\/h2>\n\n\n\n

Trong m\u1ed9t nghi\u00ean c\u1ee9u \u0111a trung t\u00e2m v\u1edbi 54 b\u1ec7nh nhi SR-aGVHD sau allo-HSCT:<\/p>\n\n\n\n