《生命科学》 2016, 28(8): 895-901
摘 要：摘 要：干细胞为解决重大医学难题带来了希望，现已开展多项干细胞治疗临床研究，且获得了一定的疗效。干细胞制剂作为干细胞治疗产品，在制备和应用过程中均需严格的操作和管理，我国还处于干细胞临床转化起步阶段，相关政策法规有待进一步细化。利用干细胞库进行干细胞制剂的标准化制备和应用已成为国际主流趋势。北京干细胞库在中国科学院“干细胞与再生医学研究”战略性先导科技专项支持下，建立了中国首家临床级干细胞库和临床级胚胎干细胞系，获得了一系列中国食品药品检定研究院的检验报告，并开展了一些干细胞的临床研究。此外，北京干细胞库参与了多项干细胞相关政策法规的制定。现将结合北京干细胞库的研究进展，对临床级干细胞制剂的管理和临床级干细胞库的建设进行综述，以期为我国干细
胞研究领域的健康发展贡献一己之力。
Abstract: Abstract: Stem cells have brought hopes for solving major medical difficulties， and a number of clinical studies on stem cell therapy have been conducted and some of them showed， to some extent， efficacy. As a type of stem cell therapeutic products， stem cell-based medicinal products shall be strictly manipulated and managed during preparation and application. Since we are still at the starting stage of clinical translation of stem cells， relevant policies and regulations in our country need further detailing. Utilizing stem cell bank to standardize the preparation and application of stem cell-based medicinal products has become international mainstream trends. Supported by the Strategic Priority Research Program of Chinese Academy of Sciences， Beijing stem cell bank has established the first clinical grade stem cell bank and clinical grade stem cell lines， obtained a series of Quality Inspection Reports issued by the National Institutes for Food and Drug Control， and carried out several clinical studies with stem cells. Moreover， Beijing stem cell bank participated in the formulation of a number of policies and regulations related to stem cells. In this paper， based on the research progress of Beijing stem cell bank， we will review the management of clinical-grade stem cell-based medicinal products and the construction of clinical-grade stem cell bank， hoping to make some contributions to the healthy development of stem cell research in our country.
