干细胞临床使用有效性和安全性及其对监管的启示

李欣; 陆东哲; 周萍; 张懿中; 李昂; 王晓熙; 吴朝晖; 薛迪

doi:10.19428/j.cnki.sjpm.2022.21988

干细胞临床使用有效性和安全性及其对监管的启示

Effectiveness and safety of clinical use of stem cells and its implications for regulations

摘要

摘要:
目的分析不同类型干细胞临床使用的有效性和安全性，为政府监管干细胞临床使用提供依据。
方法检索国内外6个文献数据库以获取2010年1月—2020年7月的相关研究文献，并进行系统性综述。
结果 72篇纳入文献涉及干细胞临床使用的有效性与安全性。虽然干细胞临床使用对部分疾病具有一定的治疗效果，但其长期疗效与安全性、尤其是致瘤性等潜在风险仍需进一步评估。
结论临床医师应充分权衡干细胞临床使用的获益与风险，政府相关部门应加强对干细胞临床研究与应用的伦理监管和干细胞产品上市的监管，以保障患者权益。

Abstract:
Objective To analyze the effectiveness and safety of clinical use of different types of stem cells to provide evidence for governmental supervision of key issues in clinical utilization of stem cells.
Methods Six literature databases in China and abroad were searched for relevant literature published from January 2010 to July 2020， and a systematic review was conducted.
Results The study showed 72 studies concerning the effectiveness and safety of different types of stem cells in clinical utilization. Although clinical utilization of stem cells had some therapeutic effects for certain diseases， their long-term effect and safety need to be further evaluated， especially their potential risk of tumorigenicity.
Conclusion To protect the patients’ interest， physicians should fully weigh the benefits against the risks of clinical utilization of stem cells， and relevant governmental departments should strengthen supervision of ethics of clinical research and therapies involving stem cells as well as supervision of stem cell products.

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