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细胞治疗临床试验现状分析

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细胞治疗作为一种新兴治疗手段在恶性肿瘤、罕见病等疑难重症领域显示出良好的疗效.使用系统检索方式全面了解国内、国际细胞治疗临床试验开展情况和实践难点.目前,国内、国际细胞治疗临床试验均处于较初级阶段,我国处于国际较领先地位.本文着重从受试人群选择、细胞来源与采集、细胞制剂的运输与保存、不良事件监测与管理等几个角度分析细胞治疗临床试验实践难点,并提出针对性解决方案,为长远统筹、精准管理、严谨实施细胞治疗临床试验提供建设性意见.
Current situation analysis of cell therapy clinical trials
As a new treatment,cell therapy has shown good therapeutic effects in difficult-to-cure and severe diseases such as malignant tumors and rare diseases.A systematic search was applied in order to comprehensively understand the development of domestic and international cell therapy clinical trials and practical difficulties.At present,domestic and international cell therapy clinical trials are all in relatively early stage,and China is in a leading position in the world.This paper focuses on analyzing the practical difficulties in cell therapy clinical trials from four perspectives:selection of population,source and collection of cells,transportation and preservation of cell preparations,monitoring and management of adverse events,and puts forward targeted solutions to provide constructive suggestions for long-term planning,accurate management,and rigorous implementation of cell therapy clinical trials.

cell therapyclinical trialstudy populationadverse events management

李丰杉、冯仕银、余勤

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四川大学华西第二医院临床试验伦理专业委员会办公室,成都 610041

四川大学华西第二医院药学部,成都 610041

四川大学华西第二医院国家药品监督管理局药物制剂体内外相关性技术研究重点实验室,成都 610041

四川大学华西第二医院出生缺陷与相关疾病教育部重点实验室,成都 610041

四川大学华西第二医院国家药物临床试验机构,成都 610041

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细胞治疗 临床试验 受试人群 不良事件管理

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(11)