《生命科学》 2011, 23(1): 127-134

关于干细胞临床产业化的一些思考

邹　曦¹，陈海涛¹，赵春林^1，2*

1 北京京蒙高科干细胞技术有限公司，北京100085，2 无锡安龙生物技术有限公司，无锡214092

摘　要：摘　要：干细胞的基础研究和临床应用是近几年国内外的热点之一。但是因为没有产业化的明确途径，这个领域的产业化发展缓慢，很有可能像基因治疗和肿瘤疫苗的产业化一样无疾而终。本文探讨了干细胞治疗能够产业化之前需要解决的几个问题。从技术层面，我们比较了胚胎干细胞和成体干细胞，自体干细胞和异体干细胞的优缺点和国内外公司采取的一些途径。从政策方面，我们探讨了把干细胞治疗作为一种医疗技术还是一类医药产品的优缺点，比较了美国FDA和国内监管部门的相关政策，也提出了进一步的问题。最后，我们以美国FDA刚刚批准的Provenge为例，对细胞治疗和干细胞治疗的产业化提出了一些希望和想法。
关键词：干细胞；胚胎干细胞；细胞治疗；医疗技术；医药产业；药物研发；干细胞产业化；Provenge

Several issues to consider before the industrialization of stem cell therapy and its clinical applications

ZOU Xi¹， CHEN Hai-Tao¹， ZHAO Chun-Lin^{1， 2*}

1 Beijing Jingmeng Stem Cell Technology Inc.， Beijing 100085， China; 2 Wuxi Anlongmed， Inc.， Wuxi 214092， China

Abstract: Abstract: Stem cell research and its clinical application are currently two of the hottest areas in research and clinical field. However， without a clear path for industrialization， its development is slow， and is likely to dwindle away as the clinical development of gene therapy and tumor vaccine. This article discussed several critical issues necessary before the wide clinical application of stem cell therapy. From the technical point， we compared embryonic and adult stem cell， and various approaches taken by international and domestic firms. From the policy stand point， we discussed the pros and cons when stem cell therapy is treated as a medical technology or a drug candidate， and the different policies taken by FDA from US and SFDA from China. Lastly， taking Provenge as an example， we provided our views and proposed a potential path for the industrialization of stem cell therapy and its clinical applications.
Key words: stem cell; embryonic stem cell; cell therapy; medical technology; pharmaceutical industry; drug development; industrialization of the stem cell therapy; Provenge