MSC-Exo在肿瘤治疗临床转化中的伦理学思考  

Ethical Considerations on Clinical Transformation of MSC-Exo in Tumor Therapy

作　　者：樊小艳 马文兵[2] 马晓 李纪鹏 FAN Xiaoyan;MA Wenbing;MA Xiao;LI Jipeng(Department of Experimental Surgery,the First Affiliated Hospital of Air Force Medical University,Xi'an 710032,China;Clinical Pharmacy,Department of Pharmacy,the First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China;School of Basic Medicine,Air Force Medical University,Xi'an 710032,China;Department of Gastroenterology Surgery,the First Affiliated Hospital of Air Force Medical University,Xi'an 710032,China)

机构地区：[1]空军军医大学第一附属医院实验外科,陕西西安710032 [2]西安交通大学第一附属医院药学部临床药学室,陕西西安710061 [3]空军军医大学基础医学院,陕西西安710032 [4]空军军医大学第一附属医院消化外科,陕西西安710032

出　　处：《中国医学伦理学》2023年第10期1103-1109,共7页Chinese Medical Ethics

基　　金：国家自然科学基金面上项目“YAP1与RNA分子m6A修饰交互调节对胃癌化疗敏感性调节的机制研究”(82172781);陕西省重点研发项目——社会发展领域“基于分泌组学联合单细胞测序评估胃癌免疫治疗时效的研究”(S2023-YF-YBSF-1673)。

摘　　要：近些年,间充质干细胞来源的外泌体(mesenchymal stem cell-derived exosome,MSC-Exo)基础科研和临床研究发展迅猛,MSC-Exo在临床前和临床研究中表现出良好的抗肿瘤效果。但是由于其来源和功能多种多样,MSC-Exo治疗在临床转化和应用中仍存在很多的问题,包括MSC-Exo适用的肿瘤类型和作用机制模糊、临床研究过程中的风险性/获益问题、缺乏安全/有效性评估标准、准入标准不严以及相关监管体系待完善等伦理学问题。干细胞治疗的临床转化和应用相关的技术指南和监管政策不断完善,因此,为了有效规避伦理风险,规范MSC-Exo治疗的临床转化和应用相关的研究和治疗,提高MSC-Exo在肿瘤治疗中的安全性和有效性,提出通过深化MSC-Exo与肿瘤调控关系的临床研究、加强风险/获益分析、监督提升研究者的职业素养、深植研究参与者不受伤害原则、构建完善相关监管体系以及提高伦理委员会审查能力,促使MSC-Exo快速实现临床转化,为肿瘤患者带来福音。In recent years,basic scientific research and clinical studies on mesenchymal stem cell-derived exosome(MSC-Exo)have developed rapidly.MSC-Exo has shown good anti-tumor effects in preclinical and clinical studies.However,due to its diverse sources and functions,MSC-Exo therapy still faces many ethical issues in clinical conversion and application,including the unclear tumor types and mechanisms of action applicable to MSC-Exo,the risk/benefit issues in the process of clinical research,the lack of safety/effectiveness evaluation standards,lax access standards,and the incomplete regulatory systems.The technical guidelines and regulatory policies related to the clinical transformation and application of stem cell therapy are constantly improving.Therefore,to effectively avoid ethical risks,regulate the research and treatment related to the clinical transformation and application of MSC-Exo therapy,and improve the safety and efficacy of MSC-Exo therapy in tumor therapy,it is proposed to deepen clinical research on the relationship between MSC-Exo and tumor regulation,strengthen the risk/benefit analysis,supervise and improve the professional quality of researcher,deeply root in the principle of subjects not to be harmed,construct and perfect the relevant regulatory system,and improve the reviewing ability of the ethics committee,so as to promote the rapid clinical transformation of MSC-Exo and bring good news to cancer patients.

关 键 词：MSC-Exo 肿瘤治疗 临床转化 肿瘤患者 

分 类 号：R-052[医药卫生]