干细胞治疗药即将在韩国问世

细胞海洋

韩国食品医药安全厅24日表示，治疗急性心肌梗塞药物“Hearticellgram-AMI”出售申请获得批准，全部批准程序将在近日完成。Hearticellgram-AMI若获许可，将会成为全球首例利用干细胞制成的治疗药。    [: }0 |( b3 [& s' c

7 i2 K0 H! }# a* g    据悉，Hearticellgram-AMI已具备优秀医药品制造管理基准（GMP）材料、安全性和有效性批准材料等所需材料。  
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    韩国制药公司FCBPharmicell今年3月提交的Hearticellgram-AMI有效性和安全性获得审议通过，本周通过了有关标准和实验方法，以及GMP材料的审议。由于现已通过了三项必要的审议，只要经过行政程序，可望于本月内获得出售批准。  
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    食药厅生物局的有关人士表示，由于是一种新药，在出售批准后将设定3年再许可条件，如此将可以在月底前完成所有出售批准程序。
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rain2402

真的假的啊？有什么成分呢？

robort45

Korea to approve world’s 1st stem cell therapeutic drug  / a: H$ O9 @) ]/ W$ Y3 v5 `

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; A8 ^7 z" o! p$ X7 p) bKorea will approve the world’s first stem cell therapeutic drug, the Korea Food and Drug Administration said Friday. 6 V+ @- m5 g6 ]0 c
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The state-run regulator said Hearticellgram-AMI, a stem cell medication for acute myocardial infarction manufactured by the bio-venture company FCB-Pharmcell, will be approved early next month. This will be the world`s first approval of a medication using adult stem cells.
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Stem cells have the ability to be differentiated in body organs such as neurons, blood and cartilage. If injected into the body after proliferation, they find their way to damaged regions to heal them.
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1 L6 r. A' Z# G& GClinical trials on the effectiveness and safety of the groundbreaking drug have been conducted on 40 patients over the past five years. The trial results showed a rise of just 5.93 percent in the heart ejection fraction in the patients, while another 40 patients who did not take the drug saw their fraction rise 1.76 percent.
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% a( n, D" s  p+ vThe heart ejection fraction is the share of blood ejection from the heart`s left ventricle to the left atrium, and is a gauge for the improvement of heart function.
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  A+ `/ n/ t, u) x. w- M8 h& }& [7 U% p: nAn FCB-Pharmcell source said, “If 100 percent of heart function is considered the basis, a 5-percent increase in the heart ejection fraction means a 5-percent improvement. So this translates into around a 10-percent increase for someone whose heart functions at 50-percent capacity.”
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# }6 S5 @! E) m+ |" ^The drug is classified as "ethical" and directly injected to a heart blood vessel. It will be available by prescription as early as September.
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: f9 h1 q7 X# V7 w( k& o& {As of 2009, 68,021 Koreans suffered from acute myocardial infarction. The drug manufacturer said 3-5 percent of such patients in serious condition will be treated first with the stem cell medication.7 c, {- m# R# w
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