全球已经获批的干细胞药物

Annie100

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      目前全球只有七种干细胞药物获得审批被世界各国政府认可,主要分布在美国，韩国、欧洲、澳洲、加拿大等国家与地区3 }% ]' ]$ j6 v1 |5 T% G

1 r! w% l! w! v4 r     全球被审批的7种干细胞药物中，有三种是经过两国国家审批的，比如比利时的TiGenix公司研发的ChondroCelect 干细胞药物，2009年通过了欧洲EMA审批通过，2013年又通过美国的FDA的审批。美国Osiris公司研发的Prochymal 干细胞药物，2009年通过美国FDA审批，同时在2012年又通过了加拿大HC审批通过。; Z/ D6 T, X) {7 b0 U. o( B( D
韩国Medi-post公司研发的Cartistem可特立，在2012.01通过韩国FDA的审批，同时在2011已经在美国进行了临床试验，到2013年通过了美国FDA的审批，同时也通过香港卫生总署的审批通过，进入了香港。* C# V" F+ n9 V* d" h# s

8 K1 z7 y2 C( w4 ]8 z% b  随着各种政府不断的加大对干细胞药物的重视，尤其很多发达国家把干细胞药物提升到国家的战略高度，将会有更多的干细胞药物投放市场，由于治疗各种疾病，给各种疑难杂症的治愈提供了新的治疗机遇。) M) K/ f' k& p* x4 b7 E
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lgfffancy

回复 Annie100 的帖子
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这个早就报道了，现在不止7种了，日本的TEMCELL也批准了，今年10月批准的。

Naplesitaly

Osiris公司研发的Prochymal 走的美国FDA孤儿药批复程序, 不算真正的批复.

yawt

这些药对应的都是治疗哪方面的疾病，有资料么？

lgfffancy

回复 yawt 的帖子% p6 T9 g! W% M
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关节炎: |4 p( H7 n: H3 f) I' B7 W( u# p
GVHD
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急性心梗
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lgfffancy

回复 Naplesitaly 的帖子
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5 K4 n! e$ r. b4 [我看很多报道说这个药已经上市了  对吧  o1 ?$ q' C6 r0 K  U- A! n
孤儿药 我还不是很了解

drowedfish

TiGenix公司研发的ChondroCelect 是干细胞疗法么？？
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* X4 g0 ]9 x! Z; tChondroCelect is a cell-based medicinal product for use in autologous chondrocyte implantation in which cells are taken from the patient’s own knee, multiplied to reach a large quantity, and then re-implanted at the site of the defect. ChondroCelect is indicated for the repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society grades III or IV) in adults.
1 A3 L& Q( U" l, s# lTreatment with ChondroCelect comprises a two-step surgical procedure. In the first step, a cartilage biopsy is obtained arthroscopically from healthy articular cartilage from a lesser-weight bearing area of the patient’s knee. Chondrocytes, the cells that produce and maintain the cartilage matrix, are isolated from the biopsy, expanded in vitro through a process based on cell characterisation, and delivered as a suspension for implantation in the same patient. ChondroCelect can be delivered nine weeks from the day of biopsy.
! n* K! I: s% E6 ~ChondroCelect was the first cell-based product approved in Europe that successfully completed the entire development track from research through clinical development to European approval and received European Marketing Authorization in October 2009 as the first Advanced Therapy Medicinal Product.ChondroCelect currently benefits from national reimbursement in the Netherlands and Spain. Effective 1 June 2014, the company has entered into a distribution agreement with Sobi (Swedish Orphan Biovitrum AB) for the exclusive marketing and distribution rights with respect to ChondroCelect in Europe (excluding Finland, where TiGenix has a pre-existing distribution agreement with Finnish Red Cross Blood Services), the Middle East and North Africa.8 x* Q( f5 }$ \2 X
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通篇只有讲是自体细胞活检后增殖？

drowedfish

草胞

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2 S! ^  @7 m' T3 e- I1 s6 [( T意大利的Holoclar不也被欧盟批了吗？治疗角膜缘干细胞缺乏症

lxonmoon

回复 drowedfish 的帖子9 h) n: }3 q+ R; D6 O. j+ R
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mark，不知有没有最新的进展？