医疗机构为主体的干细胞临床研究存在的问题与建议

Problems and Suggestions for Clinical Research Institutes to Carry Out Clinical Research of Stem Cells

以国家、行业相关的政策为依据,从干细胞制剂的制备过程、临床前研究、临床研究三个方面,分析医疗机构作为责任主体开展干细胞临床研究过程中存在的问题和建议采取的解决措施。在干细胞制剂制备方面,由于不具备干细胞制剂制备条件的医疗机构需要与干细胞制剂制备机构合作才能开展干细胞临床研究,建议建立区域性制备中心和质量检测机构,实现干细胞制剂的标准化制备和质量动态检测以保证干细胞制剂的质量;在干细胞临床前研究方面,建议医疗机构依托优势学科探索干细胞治疗的适应证并开展临床前研究;在干细胞临床研究方面,建议医疗机构强化主体责任意识并探索可行的移植干细胞药代动力学研究方法与途径。在干细胞临床研究三级审核制度的基础上,由省级机构对干细胞临床研究项目的实施过程进行监管,以保证干细胞临床研究的合规性、安全性和疗效的真实评价。

Based on China policies and industry standards,this study analyzed the facing problems and provided solving suggestions for clinical research institutes to carry out clinical researches of stem cells from stem cell preparations,preclinical researches to clinical studies.For stem cell preparations,clinical research institutes that do not have the facilities for stem cell preparations need to cooperate with stem cell manufacturers to carry out stem cell clinical researches.It is suggested to set up regional stem cell banks and quality assessment facilities to standardize stem cell preparations and carry out dynamic cell quality assessments.For preclinical researches,it is suggested to explore the appropriate indications for specific diseases and perform preclinical studies by clinical research institutes based on their specialty.For clinical researches,it is suggested to enhance the awareness of principal responsibility and heighten the pharma-cokinetic studies of the transplanted stem cells.Based on the three-level supervising system for stem cell clinical researches,provincial administrations should supervise the executing process of stem cell clinical researches to ensure the authentic assessment of the conformity,safety and efficacy.