【摘要】目的：对干细胞临床研究质量控制方面进行了综合分析。方法：具体对干细胞临床研究质量控制体系的不足与面临的挑战进行综合分析，对影响干细胞临床研究质量控制的因素进行了总结与分析。结果：以当前干细胞临床研究质量控制的问题为依据，建议强化干细胞临床研究机构建设水平，积极完善质量控制体系，保证干细胞制剂质量控制，建立高质量的研究人员团队等，并协调推进干细胞临床调研。结论：通过强化干细胞临床研究质量控制，能够促进临床研究和转化效果，有着突出的临床价值。

    【关键词】干细胞；临床研究；质量控制；策略

    Strategic thinking on strengthening quality control of stem cell clinical research

    KEI Chang， KANG Yanshen， ZHANG Yingzhi

    Cutting-edge Exosome (Zhuhai Hengqin) Biomedical R&D Limited Company， Zhuhai， Guangdong 519030， China

    【Abstract】Objective：To conduct a comprehensive analysis of the quality control of clinical stem cell research.Methods：A comprehensive analysis was conducted on the shortcomings and challenges of the quality control system for stem cell clinical research，and the factors affecting the quality control of stem cell clinical research were summarized and analyzed.Results：Based on the current issues of quality control in stem cell clinical research，it is recommended to strengthen the construction level of stem cell clinical research institutions ......