干细胞资源库的标准化建设:挑战和机遇  

Challenges and opportunities in the development of standardized stem cell resource centers

作　　者：牛帅帅 王磊[1,2] 王海滢 马娟 蔡佳乐 刘鹏 于晓游 吴骏 赵同标[1,2,3] 彭耀进 郝捷[1,2,3] NIU ShuaiShuai;WANG Lei;WANG HaiYing;MA Juan;CAI Jiale;LIU Peng;YU XiaoYou;WU Jun;ZHAO TongBiao;PENG YaoJin;HAO Jie(Institute of Zoology,Chinese Academy of Sciences,Beijing 100101,China;Beijing Institute for Stem Cell and Regenerative Medicine,Beijing 100101,China;University of Chinese Academy of Sciences,Beijing 100049,China)

机构地区：[1]中国科学院动物研究所,北京100101 [2]北京干细胞与再生医学研究院,北京100101 [3]中国科学院大学,北京100049

出　　处：《中国科学：生命科学》2024年第6期1071-1081,共11页Scientia Sinica(Vitae)

基　　金：中国科学院青年创新促进会(批准号:2020084)。

摘　　要：干细胞资源在基础科研和临床转化中的重要性日益凸显,干细胞资源库的标准化建设更是成为推动干细胞与再生医学领域规范发展的关键因素.我国大部分干细胞资源库的标准化建设仍处于起步阶段,面临资源合规性建设不健全、质量标准体系建设不够完善、资源收集和共享渠道不流畅以及可持续性发展规划与建设不足等多方面挑战.这些挑战不仅限制了干细胞资源库的高质量发展,而且在很大程度上阻碍了该领域的规范化进程.有鉴于此,本文深入分析干细胞资源库在推动相关领域发展中的关键作用及面临的主要挑战,阐明标准化建设的重要性和紧迫性,并进一步探讨我国干细胞资源库的发展现状及标准化建设的可行路径.通过加强合规性建设、质量管理、数据化建设和国际合作等,干细胞资源库将有助于推动再生医学的健康发展,为基础研究和临床应用提供高质量的细胞资源,促进生物医药领域的持续创新.The increasing importance of stem cell resources in both fundamental research and clinical translation highlights the crucial role of standardizing stem cell resource centers for advancing stem cells and regenerative medicine.However,most stem cell resource centers in China are still in the early stages of standardization.They are confronted with multifaceted challenges,including the inadequate compliance construction of cell resources,the incomplete quality standard system,inefficiencies in resource collection and sharing approaches,and shortcomings in sustainable development planning and implementation.These challenges not only constrain the high-quality advancement of stem cell resource centers but also significantly hinder the standardization progression in the field.In light of this,this review conducts a thorough analysis of the crucial role of stem cell resource centers in promoting the development of related fields and the main challenges they face.It emphasizes the importance and urgency of standardization efforts and discusses the current development status of stem cell resource centers in China,as well as feasible pathways for standardization construction.By strengthening compliance construction,quality management,data digitization,and international cooperation,stem cell resource centers are well-positioned to facilitate the healthy development of regenerative medicine,provide high-quality cell resources for basic research and clinical applications,and promote continuous innovation in the biopharmaceuticals field.

关 键 词：干细胞资源 干细胞资源库 标准化建设 干细胞与再生医学 

分 类 号：R318[医药卫生—生物医学工程]