摘要
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.
Abstract
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.
NETL
NSTL
万方数据