{"id":12040,"date":"2018-03-22T10:28:06","date_gmt":"2018-03-22T03:28:06","guid":{"rendered":"https:\/\/yhoccongdong.org\/ung-thu\/can-bang-giua-an-toan-va-phat-minh-cho-nganh-y-hoc-tai-tao\/"},"modified":"2018-03-22T10:28:06","modified_gmt":"2018-03-22T03:28:06","slug":"can-bang-giua-an-toan-va-phat-minh-cho-nganh-y-hoc-tai-tao","status":"publish","type":"post","link":"https:\/\/yhoccongdong.com\/ung-thu\/can-bang-giua-an-toan-va-phat-minh-cho-nganh-y-hoc-tai-tao\/","title":{"rendered":"C\u00e2n b\u1eb1ng gi\u1eefa an to\u00e0n v\u00e0 ph\u00e1t minh cho ng\u00e0nh y h\u1ecdc t\u00e1i t\u1ea1o"},"content":{"rendered":"
\"C\u00e2n<\/div>\n

Li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o g\u1ed1c<\/h2>\n
Li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o g\u1ed1c \u0111em l\u1ea1i nhi\u1ec1u h\u1ee9a h\u1eb9n cho vi\u1ec7c \u0111i\u1ec1u tr\u1ecb m\u1ed9t s\u1ed1 b\u1ec7nh hi\u1ec3m ngh\u00e8o, n\u00e2ng cao ch\u1ea5t l\u01b0\u1ee3ng cu\u1ed9c s\u1ed1ng c\u1ee7a con ng\u01b0\u1eddi. Tuy nhi\u00ean, hi\u1ec7n nay, v\u00ec thi\u1ebfu nhi\u1ec1u th\u00f4ng tin khoa h\u1ecdc c\u0169ng nh\u01b0 k\u1ebft qu\u1ea3 \u0111\u00e1ng tin c\u1eady t\u1eeb c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, ng\u01b0\u1eddi b\u1ec7nh ph\u1ea3i \u0111\u1ed1i di\u1ec7n nhi\u1ec1u nguy c\u01a1 ti\u1ec1m \u1ea9n do vi\u1ec7c \u00e1p d\u1ee5ng m\u1ed9t c\u00e1ch v\u1ed9i v\u00e3 v\u00e0 b\u1ea5t c\u1ea9n. M\u1ed9t v\u1ea5n \u0111\u1ec1 \u0111\u01b0\u1ee3c \u0111\u1eb7t ra l\u00e2u nay trong l\u0129nh v\u1ef1c n\u00e0y l\u00e0 l\u00e0m sao \u0111\u1ec3 v\u1eeba khuy\u1ebfn kh\u00edch c\u00e1c ph\u00e1t minh, c\u1ea3i ti\u1ebfn v\u1eeba c\u00f3 th\u1ec3 gi\u00e1m s\u00e1t c\u00e1c ho\u1ea1t \u0111\u1ed9ng \u1ee9ng d\u1ee5ng \u0111\u00f3 nh\u1eb1m t\u1ea1o ra c\u00e1c li\u1ec7u ph\u00e1p v\u1eeba an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3.<\/div>\n
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\u1ede M\u1ef9, c\u00f3 v\u00f4 s\u1ed1 c\u00e1c trung t\u00e2m y t\u1ebf l\u00e0m d\u1ecbch v\u1ee5 t\u1ebf b\u00e0o g\u1ed1c v\u00e0 ph\u1ea7n nhi\u1ec1u trong s\u1ed1 \u0111\u00f3 ho\u1ea1t \u0111\u1ed9ng m\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c s\u1ef1 ch\u1ea5p thu\u1eadn v\u00e0 c\u1ea5p ph\u00e9p c\u1ee7a C\u1ee5c qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 d\u01b0\u1ee3c ph\u1ea9m (FDA). G\u1ea7n \u0111\u00e2y FDA \u0111\u00e3 c\u00f4ng b\u1ed1 m\u1ed9t c\u01a1 c\u1ea5u qu\u1ea3n l\u00fd m\u1edbi d\u00e0nh cho l\u0129nh v\u1ef1c y h\u1ecdc t\u00e1i t\u1ea1o v\u00e0 s\u1ea3n ph\u1ea9m t\u1ebf b\u00e0o g\u1ed1c, nh\u1eb1m minh b\u1ea1ch danh m\u1ee5c s\u1ea3n ph\u1ea9m n\u00e0o C\u1ea6N hay KH\u00d4NG C\u1ea6N s\u1ef1 ch\u1ea5p thu\u1eadn c\u1ee7a FDA tr\u01b0\u1edbc khi \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng v\u00e0 gi\u00fap \u0111\u1ee1 c\u00e1c c\u00f4ng ty h\u01b0\u1edbng \u0111\u1ebfn vi\u1ec7c t\u1ea1o ra nh\u1eefng s\u1ea3n ph\u1ea9m an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 cho b\u1ec7nh nh\u00e2n.<\/div>\n
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Trong b\u1ed1i c\u1ea3nh c\u00e1c th\u1eed nghi\u1ec7m v\u1ec1 t\u1ebf b\u00e0o g\u1ed1c \u1edf Vi\u1ec7t Nam \u0111ang d\u1ea7n tr\u1edf n\u00ean ph\u1ed5 bi\u1ebfn r\u1ed9ng r\u00e3i h\u01a1n, ch\u00fang t\u00f4i thi\u1ebft ngh\u0129 nh\u1eefng th\u00f4ng tin v\u1ec1 quan \u0111i\u1ec3m v\u00e0 \u0111\u1ed9ng th\u00e1i m\u1edbi c\u1ee7a FDA t\u1eeb b\u00e0i b\u00e1o v\u1eeba \u0111\u01b0\u1ee3c \u0111\u0103ng tr\u00ean t\u1ea1p ch\u00ed NEJM h\u00f4m 8\/3\/2018 c\u00f3 th\u1ec3 s\u1ebd h\u1eefu \u00edch \u0111\u1ed1i v\u1edbi m\u1ecdi ng\u01b0\u1eddi.<\/div>\n
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B\u00e0i vi\u1ebft \u0111\u01b0a ra \u0111\u1ecbnh ngh\u0129a kh\u00e1i qu\u00e1t h\u01a1n v\u1ec1 Y h\u1ecdc t\u00e1i t\u1ea1o. L\u00e2u nay ch\u00fang ta v\u1eabn th\u01b0\u1eddng \u0111\u00e1nh \u0111\u1ed3ng \u201cY h\u1ecdc t\u00e1i t\u1ea1o\u201d v\u00e0 \u201cLi\u1ec7u ph\u00e1p t\u1ebf b\u00e0o g\u1ed1c\u201d l\u00e0 m\u1ed9t: \u0110i\u1ec1u \u0111\u00f3 kh\u00f4ng ho\u00e0n to\u00e0n \u0111\u00fang.<\/div>\n

Y h\u1ecdc t\u00e1i t\u1ea1o<\/h2>\n
\u201cY h\u1ecdc t\u00e1i t\u1ea1o l\u00e0 l\u0129nh v\u1ef1c li\u00ean quan \u0111\u1ebfn vi\u1ec7c thay th\u1ebf, thao t\u00e1c hay t\u00e1i t\u1ea1o t\u1ebf b\u00e0o, m\u00f4, hay c\u01a1 quan c\u1ee7a con ng\u01b0\u1eddi \u0111\u1ec3 thi\u1ebft l\u1eadp, kh\u00f4i ph\u1ee5c v\u00e0 t\u0103ng c\u01b0\u1eddng ch\u1ee9c n\u0103ng b\u00ecnh th\u01b0\u1eddng v\u1ed1n c\u00f3. S\u1ea3n ph\u1ea9m c\u1ee7a ng\u00e0nh y h\u1ecdc t\u00e1i t\u1ea1o bao g\u1ed3m c\u00e1c li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o, c\u00e1c s\u1ea3n ph\u1ea9m m\u00f4 d\u00e0nh cho tr\u1ecb li\u1ec7u, s\u1ea3n ph\u1ea9m m\u00f4 v\u00e0 t\u1ebf b\u00e0o c\u1ee7a ng\u01b0\u1eddi v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m k\u1ebft h\u1ee3p gi\u1eefa t\u1ebf b\u00e0o v\u00e0 c\u00e1c thi\u1ebft b\u1ecb nh\u1ecf nh\u01b0 gi\u00e1 th\u1ec3 gi\u00fap t\u1ebf b\u00e0o ph\u00e1t tri\u1ec3n. Trong \u0111\u00f3 t\u1ebf b\u00e0o g\u1ed1c tr\u01b0\u1edfng th\u00e0nh l\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng h\u1ea5p d\u1eabn, ti\u1ec1m n\u0103ng v\u00e0 thu h\u00fat nh\u1ea5t v\u1edbi k\u00ec v\u1ecdng s\u1ebd gi\u00fap c\u1ea3i thi\u1ec7n nhi\u1ec1u lo\u1ea1i b\u1ec7nh nan y hi\u1ec7n nay.\u201d<\/span><\/div>\n
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B\u00e0i b\u00e1o c\u0169ng ch\u1ec9 ra s\u1ef1 kh\u00e1c bi\u1ec7t c\u01a1 b\u1ea3n trong nghi\u00ean c\u1ee9u v\u00e0 \u1ee9ng d\u1ee5ng c\u1ee7a 2 lo\u1ea1i t\u1ebf b\u00e0o g\u1ed1c ph\u1ed5 bi\u1ebfn nh\u1ea5t hi\u1ec7n nay: t\u1ebf b\u00e0o g\u1ed1c t\u1ea1o m\u00e1u v\u00e0 t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4. Trong khi vi\u1ec7c \u1ee9ng d\u1ee5ng c\u1ee7a t\u1ebf b\u00e0o g\u1ed1c t\u1ea1o m\u00e1u th\u00e0nh c\u00f4ng nh\u1edd c\u00f3 s\u1ed1 li\u1ec7u, b\u1eb1ng ch\u1ee9ng phong ph\u00fa t\u1eeb nhi\u1ec1u nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng, c\u1eadn l\u00e2m s\u00e0ng, v\u00e0 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, th\u00ec c\u00e1c \u1ee9ng d\u1ee5ng v\u1edbi t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 l\u1ea1i kh\u00f4ng c\u00f3 nhi\u1ec1u c\u01a1 s\u1edf. V\u1eady m\u00e0 ng\u01b0\u1eddi ta v\u1eabn \u0111ang s\u1eed d\u1ee5ng t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 m\u1ed9t c\u00e1ch tr\u00e0n lan b\u1ea5t ch\u1ea5p c\u00f3 ph\u01b0\u01a1ng ph\u00e1p khoa h\u1ecdc hay kh\u00f4ng.<\/div>\n

T\u1ebf b\u00e0o g\u1ed1c t\u1ea1o m\u00e1u v\u00e0 t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4<\/h2>\n
\u201cM\u1ed9t trong nh\u1eefng lo\u1ea1i t\u1ebf b\u00e0o g\u1ed1c tr\u01b0\u1edfng th\u00e0nh \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u s\u00e2u, r\u1ed9ng nh\u1ea5t l\u00e0 t\u1ebf b\u00e0o g\u1ed1c t\u1ea1o m\u00e1u. Ph\u01b0\u01a1ng ph\u00e1p c\u1ea5y gh\u00e9p t\u1ebf b\u00e0o g\u1ed1c t\u1ea1o m\u00e1u r\u00f5 r\u00e0ng c\u00f3 hi\u1ec7u qu\u1ea3 khi c\u1ee9u \u0111\u01b0\u1ee3c nhi\u1ec1u b\u1ec7nh nh\u00e2n m\u1eafc c\u00e1c b\u1ec7nh m\u00e1u l\u00e0nh t\u00ednh v\u00e0 \u00e1c t\u00ednh. T\u1eeb bao l\u00e2u nay,<\/span> c\u00e1c nh\u00e0 khoa h\u1ecdc v\u00e0 b\u00e1c s\u0129 \u0111\u00e3 hi\u1ec3u bi\u1ebft kh\u00e1 t\u01b0\u1eddng t\u1eadn v\u1ec1 hi\u1ec7u qu\u1ea3 v\u00e0 t\u00e1c d\u1ee5ng ph\u1ee5 c\u1ee7a ph\u01b0\u01a1ng ph\u00e1p tr\u1ecb li\u1ec7u n\u00e0y. Tuy nhi\u00ean, c\u00e1c hi\u1ec3u bi\u1ebft \u0111\u1ed1i v\u1edbi nhi\u1ec1u lo\u1ea1i t\u1ebf b\u00e0o g\u1ed1c tr\u01b0\u1edfng th\u00e0nh kh\u00e1c,<\/span> nh\u01b0 t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 (MSC),<\/span> th\u00ec ch\u01b0a \u0111\u1ea1t \u0111\u1ebfn m\u1ee9c t\u01b0\u01a1ng t\u1ef1. D\u00f9 s\u1ed1 l\u01b0\u1ee3ng c\u00e1c th\u1eed nghi\u1ec7m \u1edf giai \u0111o\u1ea1n \u0111\u1ea7u v\u1edbi t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 c\u1ee9 t\u0103ng l\u00ean, s\u1ef1 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 cho nh\u1eefng quy tr\u00ecnh li\u00ean quan \u0111\u1ebfn lo\u1ea1i t\u1ebf b\u00e0o n\u00e0y, th\u00f4ng qua c\u00e1c nghi\u00ean c\u1ee9u, v\u1eabn c\u00f2n v\u00f4 c\u00f9ng h\u1ea1n ch\u1ebf. T\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho nhi\u1ec1u lo\u1ea1i b\u1ec7nh kh\u00e1c nhau<\/span> \u1edf ng\u01b0\u1eddi, t\u1eeb ung th\u01b0 cho \u0111\u1ebfn lo\u1ea1i b\u1ec7nh t\u00e1c \u0111\u1ed9ng \u0111\u1ebfn h\u1ec7 th\u1ea7n kinh trung \u01b0\u01a1ng nh\u01b0 Alzheimer cho d\u00f9 k\u1ebft qu\u1ea3 t\u1eeb c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf ch\u1eb7t ch\u1ebd v\u1eabn c\u00f2n qu\u00e1<\/span> hi\u1ebfm hoi. C\u00f3 hai l\u00fd do th\u01b0\u1eddng \u0111\u01b0\u1ee3c d\u00f9ng \u0111\u1ec3 gi\u1ea3i th\u00edch r\u1eb1ng t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3: (1) v\u00ec ch\u00fang c\u00f3 t\u00ednh \u0111i\u1ec1u ho\u00e0 mi\u1ec5n d\u1ecbch v\u00e0 (2) ch\u00fang c\u00f3 th\u1ec3 bi\u1ec7t ho\u00e1 t\u01b0\u01a1ng \u1ee9ng v\u1edbi d\u1ea1ng m\u00f4i tr\u01b0\u1eddng ch\u00fang ti\u1ebfp x\u00fac. Hi\u1ec7n nay nhi\u1ec1u t\u00e0i li\u1ec7u v\u00e0 b\u1eb1ng ch\u1ee9ng khoa h\u1ecdc x\u00e1c th\u1ef1c cho th\u1ea5y<\/span> m\u1ed9t c\u00e1ch kh\u00e1 ch\u1eafc ch\u1eafn r\u1eb1ng nh\u1eefng \u0111i\u1ec1u n\u00e0y kh\u00f4ng ph\u1ea3i lu\u00f4n \u0111\u00fang.\u201d<\/span><\/div>\n

H\u01b0\u1edbng ph\u00e1t tri\u1ec3n li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o g\u1ed1c<\/h2>\n
Qua b\u00e0i b\u00e1o n\u00e0y, FDA c\u0169ng th\u1ec3 hi\u1ec7n r\u00f5 quan \u0111i\u1ec3m: mu\u1ed1n T\u1eadp Trung ph\u00e1t tri\u1ec3n li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o g\u1ed1c theo h\u01b0\u1edbng An To\u00e0n v\u00e0 Hi\u1ec7u Qu\u1ea3, thay v\u00ec ph\u00e1t tri\u1ec3n nhanh, r\u1ed9ng m\u00e0 nhi\u1ec1u r\u1ee7i ro.<\/div>\n
\u201cC\u00f9ng l\u00fac \u0111\u00f3, vi\u1ec7c \u1ee9ng d\u1ee5ng t\u1ebf b\u00e0o g\u1ed1c c\u0169ng d\u1eabn t\u1edbi m\u1ed9t v\u00e0i h\u1eadu qu\u1ea3 nghi\u00eam tr\u1ecdng. Cho d\u00f9 kh\u00f4ng c\u00f3 nh\u1eefng s\u1ef1 vi\u1ec7c nghi\u00eam tr\u1ecdng \u0111\u00f3 th\u00ec vi\u1ec7c s\u1eed d\u1ee5ng nh\u1eefng li\u1ec7u ph\u00e1p m\u00e0 hi\u1ec7u qu\u1ea3 ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ee9ng minh c\u0169ng l\u00e0m h\u1ea1i t\u1edbi b\u1ec7nh nh\u00e2n v\u00e0 s\u1ee9c kho\u1ebb c\u1ed9ng \u0111\u1ed3ng. S\u1ed1 l\u01b0\u1ee3ng c\u00e1c li\u1ec7u ph\u00e1p an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3, d\u1ef1a v\u00e0o c\u00e1c k\u1ebft qu\u1ea3 \u0111\u00e1ng tin c\u1eady c\u00f3 \u0111\u01b0\u1ee3c t\u1eeb c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf t\u1ed1t, ng\u00e0y m\u1ed7i t\u0103ng l\u00ean. Vi\u1ec7c t\u1ed1i quan tr\u1ecdng l\u00e0 c\u1ea7n t\u1eadp trung n\u1ed7 l\u1ef1c \u0111\u1ec3 th\u00fac \u0111\u1ea9y s\u1ef1 ph\u00e1t tri\u1ec3n nh\u1eefng li\u1ec7u ph\u00e1p nh\u01b0 v\u1eady thay v\u00ec qu\u1ea3ng b\u00e1 c\u00e1c s\u1ea3n ph\u1ea9m v\u1edbi hi\u1ec7u qu\u1ea3 l\u00e2m s\u00e0ng c\u00f2n ch\u01b0a r\u00f5 r\u00e0ng v\u00e0 \u1ea9n ch\u1ee9a nhi\u1ec1u nguy c\u01a1.\u201d<\/span><\/div>\n
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\u0110\u1ec3 qu\u1ea3n l\u00fd c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan \u0111\u1ebfn y h\u1ecdc t\u00e1i t\u1ea1o, FDA chia th\u00e0nh 2 nh\u00f3m: (1) nh\u00f3m b\u1ecb r\u00e0ng bu\u1ed9c b\u1edfi c\u1ea3 2 \u0111i\u1ec1u 351 v\u00e0 361, v\u00e0 (2) nh\u00f3m ch\u1ec9 b\u1ecb r\u00e0ng bu\u1ed9c v\u1edbi \u0111i\u1ec1u 361 m\u00e0 th\u00f4i.<\/div>\n
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\u201cFDA chia c\u00e1c s\u1ea3n ph\u1ea9m t\u1ebf b\u00e0o v\u00e0 m\u00f4 ng\u01b0\u1eddi th\u00e0nh 2 nh\u00f3m: c\u1ea7n v\u00e0 kh\u00f4ng c\u1ea7n \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn tr\u01b0\u1edbc khi \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng. Nh\u1eefng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c qui \u0111\u1ecbnh trong c\u1ea3 hai \u0110i\u1ec1u 351 v\u00e0 361 l\u00e0 nh\u1eefng s\u1ea3n ph\u1ea9m sinh h\u1ecdc v\u00e0 ph\u1ea3i \u0111\u01b0\u1ee3c nghi\u00ean c\u1ee9u theo \u0111i\u1ec1u kho\u1ea3n d\u00e0nh cho quy tr\u00ecnh nghi\u00ean c\u1ee9u thu\u1ed1c m\u1edbi. Nh\u00e0 s\u1ea3n xu\u1ea5t c\u1ee7a nh\u1eefng s\u1ea3n ph\u1ea9m n\u00e0y \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u ph\u1ea3i n\u1ed9p h\u1ed3 s\u01a1 c\u1ea5p ph\u00e9p cho FDA \u0111\u1ec3 \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn tr\u01b0\u1edbc khi \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng. Ng\u01b0\u1ee3c l\u1ea1i, c\u00e1c s\u1ea3n ph\u1ea9m n\u1eb1m CH\u1ec8 trong \u0110i\u1ec1u 361 th\u00ec kh\u00f4ng c\u1ea7n \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn tr\u01b0\u1edbc khi \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng. Thay v\u00e0o \u0111\u00f3, tr\u01b0\u1edbc khi qu\u1ea3ng b\u00e1, h\u1ecd c\u1ea7n ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA v\u00e0 \u0111\u1ea3m b\u1ea3o l\u00e0 ch\u00fang \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t m\u1ed9t c\u00e1ch h\u1ee3p l\u1ec7 nh\u1eb1m ng\u0103n ch\u1eb7n vi\u1ec7c lan tr\u00e0n c\u00e1c lo\u1ea1i b\u1ec7nh nhi\u1ec5m.\u201d<\/span><\/div>\n
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\u1ee8ng d\u1ee5ng t\u01b0\u01a1ng \u0111\u1ed3ng<\/span> (homologous use)<\/span> v\u00e0 thao t\u00e1c t\u1ed1i thi\u1ec3u (minimal manipulation)<\/span> l\u00e0 hai y\u1ebfu t\u1ed1 then ch\u1ed1t \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh m\u1ed9t s\u1ea3n ph\u1ea9m c\u00f3 ph\u1ea3i l\u00e0 d\u01b0\u1ee3c ph\u1ea9m, thu\u1ed9c \u0110i\u1ec1u 361 hay kh\u00f4ng, c\u00f3 c\u1ea7n \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn hay kh\u00f4ng? \u1ee8ng d\u1ee5ng t\u01b0\u01a1ng \u0111\u1ed3ng c\u00f3 ngh\u0129a l\u00e0 t\u1ebf b\u00e0o \u0111\u00f3ng vai tr\u00f2 g\u00ec \u1edf c\u01a1 th\u1ec3 ng\u01b0\u1eddi cho, th\u00ec c\u0169ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho c\u00f9ng m\u1ee5c \u0111\u00edch \u1edf c\u01a1 th\u1ec3 ng\u01b0\u1eddi nh\u1eadn. V\u00ed d\u1ee5 t\u1ebf b\u00e0o g\u1ed1c t\u1eeb tu\u1ef7 x\u01b0\u01a1ng \u0111\u01b0\u1ee3c l\u1ea5y ra v\u00e0 gh\u00e9p l\u1ea1i v\u00e0o tu\u1ef7 x\u01b0\u01a1ng. C\u00f2n t\u1ebf b\u00e0o g\u1ed1c trung m\u00f4 l\u1ea5y ra t\u1eeb m\u00f4 m\u1ee1, m\u00e0 l\u1ea1i \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 ch\u1eefa b\u1ec7nh Alzheimer hay COPD th\u00ec kh\u00f4ng c\u00f2n l\u00e0 t\u01b0\u01a1ng \u0111\u1ed3ng n\u1eefa.<\/div>\n
\u0110\u1ec3 th\u00fac \u0111\u1ea9y s\u1ef1 ph\u00e1t tri\u1ec3n nhanh c\u00e1c s\u1ea3n ph\u1ea9m, FDA \u0111\u00e3 \u0111\u01b0a ra m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh m\u1edbi:<\/div>\n
\u201cC\u00e1c ch\u01b0\u01a1ng tr\u00ecnh x\u00fac ti\u1ebfn bao g\u1ed3m ch\u1ecdn l\u1ef1a ph\u01b0\u01a1ng th\u1ee9c nhanh, \u0111\u01b0\u1ee3c \u01b0u ti\u00ean th\u1ea9m \u0111\u1ecbnh, ch\u1ea5p thu\u1eadn nhanh v\u00e0 ch\u1ecdn l\u1ef1a nh\u01b0 m\u1ed9t li\u1ec7u ph\u00e1p \u0111\u1ed9t ph\u00e1, \u0111ang t\u1eebng b\u01b0\u1edbc \u0111\u1ea1t \u0111\u01b0\u1ee3c m\u1ee5c ti\u00eau n\u00e0y.\u201d<\/span><\/div>\n
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FDA c\u0169ng \u0111\u01b0a ra m\u1ed9t d\u1ea1ng ch\u1ee9ng nh\u1eadn m\u1edbi cho c\u00e1c s\u1ea3n ph\u1ea9m y h\u1ecdc t\u00e1i t\u1ea1o g\u1ecdi l\u00e0 RMAT. D\u1ea1ng ch\u1ee9ng nh\u1eadn n\u00e0y cho ph\u00e9p nh\u1eefng nh\u00e0 b\u1ea3o tr\u1ee3 nhi\u1ec1u l\u1ee3i th\u1ebf n\u1ebfu s\u1ea3n ph\u1ea9m c\u1ee7a h\u1ecd h\u01b0\u1edbng v\u00e0o vi\u1ec7c ch\u1eefa tr\u1ecb nh\u1eefng b\u1ec7nh hi\u1ec3m ngh\u00e8o. Tuy v\u1eady h\u1ecd c\u0169ng c\u1ea7n ph\u1ea3i \u0111\u01b0a ra m\u1ed9t s\u1ed1 b\u1eb1ng ch\u1ee9ng l\u00e2m s\u00e0ng s\u01a1 kh\u1edfi \u0111\u1ec3 ch\u1ee9ng minh \u0111\u01b0\u1ee3c li\u1ec7u ph\u00e1p c\u1ee7a h\u1ecd c\u00f3 th\u1ec3 gi\u1ea3i quy\u1ebft \u0111\u01b0\u1ee3c nhu c\u1ea7u y h\u1ecdc hi\u1ec7n ch\u01b0a \u0111\u01b0\u1ee3c \u0111\u00e1p \u1ee9ng.<\/div>\n
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\u201c\u0110\u1ec3 th\u00fac \u0111\u1ea9y c\u00e1c c\u1ea3i ti\u1ebfn trong tr\u1ecb li\u1ec7u t\u1eeb c\u00e1c li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o g\u1ed1c, c\u00f9ng v\u1edbi nh\u1eefng s\u1ea3n ph\u1ea9m t\u1ebf b\u00e0o – m\u00f4 kh\u00e1c, th\u00ec \u0110i\u1ec1u lu\u1eadt 21st Century Cure \u0111\u00e3 \u0111\u01b0a ra th\u00eam m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh x\u00fac ti\u1ebfn n\u1eefa. Theo \u0111\u00f3, s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn l\u00e0 Li\u1ec7u ph\u00e1p Y h\u1ecdc T\u00e1i t\u1ea1o T\u00e2n ti\u1ebfn (Regenerative Medicine Advanced Therapy \u2013 RMAT). … Cho \u0111\u1ebfn ng\u00e0y 29 th\u00e1ng 12 n\u0103m 2017, FDA \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c 43 y\u00eau c\u1ea7u ch\u1ee9ng nh\u1eadn RMAT, \u0111\u00e3 xem x\u00e9t 35 y\u00eau c\u1ea7u v\u00e0 c\u1ea5p ch\u1ee9ng nh\u1eadn cho 13 y\u00eau c\u1ea7u.\u201d<\/span><\/div>\n
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M\u1eb7c d\u00f9 kh\u00f4ng \u0111\u01b0a ra chi ti\u1ebft, nh\u01b0ng b\u00e0i b\u00e1o c\u0169ng n\u00f3i r\u1eb1ng FDA \u0111\u00e3 \u0111\u01b0a ra h\u01b0\u1edbng d\u1eabn t\u01b0\u1eddng t\u1eadn h\u01a1n v\u1ec1 ti\u00eau chu\u1ea9n nh\u01b0 th\u1ebf n\u00e0o g\u1ecdi l\u00e0 \u201c\u1ee8ng d\u1ee5ng t\u01b0\u01a1ng \u0111\u1ed3ng v\u00e0 thao t\u00e1c t\u1ed1i thi\u1ec3u\u201d \u0111\u1ec3 gi\u00fap nh\u1eefng ng\u01b0\u1eddi ph\u00e1t tri\u1ec3n s\u1ea3n ph\u1ea9m d\u1ec5 d\u00e0ng \u0111\u1ecbnh danh s\u1ea3n ph\u1ea9m c\u1ee7a h\u1ecd. FDA c\u0169ng \u0111\u01b0a ra kho\u1ea3ng th\u1eddi gian 36 th\u00e1ng cho ph\u00e9p nh\u1eefng ng\u01b0\u1eddi c\u00f3 s\u1ea3n ph\u1ea9m \u00edt r\u1ee7i ro xem x\u00e9t v\u00e0 n\u1ed9p \u0111\u01a1n \u0111\u1ec3 xin \u201cnghi\u00ean c\u1ee9u thu\u1ed1c m\u1edbi\u201d n\u1ebfu c\u1ea7n thi\u1ebft.<\/div>\n
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C\u01a1 quan FDA c\u0169ng v\u1eeba th\u1ef1c hi\u1ec7n m\u1ed9t b\u01b0\u1edbc ti\u1ebfn kh\u00e1c \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng nh\u1eb1m h\u1ed7 tr\u1ee3 c\u00e1c c\u00e1 nh\u00e2n v\u00e0 nh\u1eefng nh\u00f3m b\u00e1c s\u0129 \u0111i\u1ec1u tr\u1ecb trong c\u00f4ng cu\u1ed9c ph\u00e1t tri\u1ec3n li\u1ec7u ph\u00e1p y h\u1ecdc t\u00e1i t\u1ea1o. \u0110\u00f3 l\u00e0 cung c\u1ea5p ph\u01b0\u01a1ng th\u1ee9c v\u00e0 c\u00f4ng c\u1ee5 \u0111\u1ec3 t\u1eebng \u0111\u1ed1i t\u00e1c c\u00f3 th\u1ec3 h\u1ee3p t\u00e1c, h\u1ed7 tr\u1ee3 nhau c\u00f9ng ph\u00e1t tri\u1ec3n li\u1ec7u ph\u00e1p v\u00e0 c\u00f9ng \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ph\u00e9p ch\u1ee9ng nh\u1eadn .<\/div>\n
Hi v\u1ecdng r\u1eb1ng nh\u1eefng h\u00e0nh \u0111\u1ed9ng m\u1edbi n\u00e0y c\u1ee7a FDA trong l\u0129nh v\u1ef1c y h\u1ecdc t\u00e1i t\u1ea1o s\u1ebd gi\u00fap ng\u0103n ng\u1eeba nh\u1eefng r\u1ee7i ro \u0111\u1ed1i v\u1edbi b\u1ec7nh nh\u00e2n v\u00e0 th\u00fac \u0111\u1ea9y c\u00f4ng t\u00e1c nghi\u00ean c\u1ee9u, th\u1eed nghi\u1ec7m t\u1ebf b\u00e0o g\u1ed1c \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n m\u1ed9t c\u00e1ch t\u00edch c\u1ef1c v\u00e0 hi\u1ec7u qu\u1ea3 h\u01a1n n\u1eefa.<\/div>\n
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C\u00f2n \u1edf Vi\u1ec7t Nam, c\u00e1c nghi\u00ean c\u1ee9u v\u00e0 th\u1eed nghi\u1ec7m t\u1ebf b\u00e0o g\u1ed1c tr\u00ean ng\u01b0\u1eddi \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 v\u00e0 qu\u1ea3n l\u00fd nh\u01b0 th\u1ebf n\u00e0o? N\u1ebfu b\u1ea1n \u0111\u1ecdc c\u00f3 th\u00f4ng tin, xin chia s\u1ebb cho m\u1ecdi ng\u01b0\u1eddi c\u00f9ng bi\u1ebft. C\u00e1m \u01a1n r\u1ea5t nhi\u1ec1u.<\/div>\n

T\u00e0i li\u1ec7u tham kh\u1ea3o<\/h2>\n

http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMsr1715626?query=TOC<\/a>)<\/p>\n","protected":false},"excerpt":{"rendered":"

Li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o g\u1ed1c \u0111em l\u1ea1i nhi\u1ec1u h\u1ee9a h\u1eb9n cho vi\u1ec7c \u0111i\u1ec1u tr\u1ecb m\u1ed9t s\u1ed1 b\u1ec7nh hi\u1ec3m ngh\u00e8o, n\u00e2ng cao ch\u1ea5t l\u01b0\u1ee3ng cu\u1ed9c s\u1ed1ng c\u1ee7a con ng\u01b0\u1eddi.<\/p>\n","protected":false},"author":380,"featured_media":12039,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[3841,3842,3843,3844],"series":[3817],"coauthors":[],"acf":[],"yoast_head":"\nC\u00e2n b\u1eb1ng gi\u1eefa An To\u00e0n v\u00e0 Ph\u00e1t minh cho ng\u00e0nh Y h\u1ecdc t\u00e1i t\u1ea1o - Y H\u1ecdc C\u1ed9ng \u0110\u1ed3ng<\/title>\n<meta name=\"description\" content=\"Li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o g\u1ed1c \u0111em l\u1ea1i nhi\u1ec1u h\u1ee9a h\u1eb9n cho vi\u1ec7c \u0111i\u1ec1u tr\u1ecb m\u1ed9t s\u1ed1 b\u1ec7nh hi\u1ec3m ngh\u00e8o, n\u00e2ng cao ch\u1ea5t l\u01b0\u1ee3ng cu\u1ed9c s\u1ed1ng c\u1ee7a con ng\u01b0\u1eddi.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/yhoccongdong.com\/ung-thu\/can-bang-giua-an-toan-va-phat-minh-cho-nganh-y-hoc-tai-tao\/\" \/>\n<meta property=\"og:locale\" content=\"vi_VN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"C\u00e2n b\u1eb1ng gi\u1eefa An To\u00e0n v\u00e0 Ph\u00e1t minh cho ng\u00e0nh Y h\u1ecdc t\u00e1i t\u1ea1o - Y H\u1ecdc C\u1ed9ng \u0110\u1ed3ng\" \/>\n<meta property=\"og:description\" content=\"Li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o g\u1ed1c \u0111em l\u1ea1i nhi\u1ec1u h\u1ee9a h\u1eb9n cho vi\u1ec7c \u0111i\u1ec1u tr\u1ecb m\u1ed9t s\u1ed1 b\u1ec7nh hi\u1ec3m ngh\u00e8o, n\u00e2ng cao ch\u1ea5t l\u01b0\u1ee3ng cu\u1ed9c s\u1ed1ng c\u1ee7a con ng\u01b0\u1eddi.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/yhoccongdong.com\/ung-thu\/can-bang-giua-an-toan-va-phat-minh-cho-nganh-y-hoc-tai-tao\/\" \/>\n<meta property=\"og:site_name\" content=\"D\u1ef1 \u00e1n Ung Th\u01b0\" \/>\n<meta property=\"article:author\" content=\"https:\/\/www.facebook.com\/kimvybear\" \/>\n<meta property=\"article:published_time\" content=\"2018-03-22T03:28:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/yhoccongdong.com\/ung-thu\/wp-content\/uploads\/sites\/2\/2018\/03\/can-bang-giua-an-toan-va-phat-minh-cho-nganh-y-hoc-tai-tao.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"660\" \/>\n\t<meta property=\"og:image:height\" content=\"330\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"TS. 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