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nature biotechnology （volume 29 number 10 october 2011）发布的关于Hearticellgram-AMI的消息
/ L1 v1 q& v( I6 }South Korea's stem cell approval
K: Q( `1 ~$ X: X9 f• Heiko Yang
8 @, `# O1 P9 r8 x; }, J wNature Biotechnology8 _# J& m3 d3 u W% E' n- f& X& L- M9 Z
13 October 2011" ^$ g* { u; y7 f9 u; b% z
On July 1, the Korea Food and Drug Administration approved a stem cell treatment for acute myocardial infarction developed by FCB-Pharmicell of Seongnam. Locals view the regulatory go-ahead as a world first and also a vote of confidence for the nation's scientific expertise following the cloning scandal that found stem cell scientist Woo Suk Hwang guilty of fraud (Nat. Biotechnol. 24, 745–747, 2006). The treatment, Hearticellgram-AMI, is an autologous stem cell transplant of mesenchymal stem cells, cultured from a patient's own bone marrow, injected into the coronary arteries. The approval comes after six years of clinical trials; as yet, the company has not published results in a peer-reviewed journal. Another major caveat is clinical efficacy: patients showed a 6% improvement in the left ventricular ejection fraction used as measure of heart function six months after one dose of Hearticellgram-AMI. “6% is not terrible. You're getting a modest improvement, and that might be the best they ever do” says University of Michigan cardiologist Mark Russell. For Hearticellgram-AMI, a price tag of 20-million Won ($19,000) may be overly optimistic,” says Russell.2 k% k) L) H7 x1 k" v( K+ V# x
韩国食品和药品监督管理局批准“Hearticellgram-AMI”干细胞药治疗急性心肌梗死, u* G! N- z2 j$ e
7月1日，韩国食品和药品监督管理局批准 “Hearticellgram-AMI”干细胞药用于治疗急性心肌梗死。Hearticellgram-AMI将成为全球首个利用干细胞制成的治疗急性心肌梗死药。这无疑是继干细胞科学家黄禹锡犯欺诈罪（Nat.生物24，745-747，2006年发现的克隆丑闻）之后，增加国民乃至世界对该民族科学专业知识信心。" c3 [4 ?' ?/ ^( r5 c: q
主要的治疗方法是，从患者自身骨髓中提取间质干细胞移植注入冠状动脉。干细胞获准用于急性心肌梗死治疗主要基于6年临床试验及干细胞治疗心肌梗死治疗临床效果。研究发现干细胞移植6个月后，患者左室射血分数改善6%。，密歇根大学的心脏病专家马克拉塞尔认为，左室射血分数改善6%。患者可达到最大程度的改善。太不可思议！且一次治疗费用不超过20万韩元（19,000美元）。不过该公司并没有发表同行评审期刊结果。2 g- J" x7 C9 F4 ^. z" S
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发表于 2011-11-25 14:20
发表于 2011-11-27 00:36
