我国脐带血造血干细胞库法规贯彻的现状与思考  

Present Situation and Thinking on the Implementation of Regulations for Cord Blood Hematopoietic Stem Cell Bank in China

作　　者：雒猛 王忠 张秀涛 高峰 赵清刚 刘金玲 LUO Meng;WANG Zhong;ZHANG Xiutao;GAO Feng;ZHAO Qinggang;LIU Jinling(Laboratory Center,Shandong Cord Blood Hematopoietic Stem Cell Bank,Ji’nan Shandong 250102,China;Laboratory Center,Shandong Qilu Stem Cell Engineering Co.Ltd.,Ji’nan Shandong 250102,China;Office,Shandong Blood Center,Ji’nan Shandong 250013,China)

机构地区：[1]山东省脐带血造血干细胞库实验中心,山东济南250102 [2]山东省齐鲁干细胞工程有限公司实验中心,山东济南250102 [3]山东省血液中心办公室,山东济南250013

出　　处：《中国卫生标准管理》2022年第13期15-18,共4页China Health Standard Management

摘　　要：目的分析我国脐带血造血干细胞库(以下称脐带血库)法规贯彻情况,并对国内脐带血库进一步完善法规标准提出改进建议。方法通过文献检索、法律法规和技术文件的学习、与国际细胞治疗委员会(the foundation for the accreditation of cellular therapy,FACT)对标、脐带血库间交流与沟通、专家访谈等方法,了解国内脐带血库法规执行存在的问题,并分析其原因。结果我国脐带血库经历近20年的发展,为临床患者治疗做出了巨大的贡献,但运行中存在法规滞后的情况,脐带血在运输、制备、检测、留样等环节存在法规不明确或缺少指导性标准文件。结论我国脐带血库运行中存在需要提升的地方,需完善修改相关的法律法规,制定相关的脐带血标准,为临床提供质量可靠的脐带血。Objective To analyze the implementation of the regulations for cord blood hematopoietic stem cell bank(hereinafter referred to as cord blood bank)in China,and put forward some suggestions for improving the establishment of unified and concrete standards of cord blood bank in China.Methods By means of literature search,study of laws,regulations and technical documents,benchmarking with the foundation for the accreditation of cellular therapy(FACT),exchange and communication among cord blood banks,and expert interviews,the existing problems in the implementation of domestic cord blood bank regulations were understood,and the causes were analyzed.Results After nearly 20 years’development,the cord blood banks in China have made great contributions to the treatment of clinical patients.However,laws and regulations in cord bank operation are lagging behind,and there are unclear standards or lack of guidance documents in transportation,preparation,testing and sample retention of cord blood.Conclusion There is room for improvement in the operation of cord blood bank in China.It is necessary to improve relevant laws and regulations,formulate or revise relevant cord blood standards,and provide reliable cord blood for clinic.

关 键 词：脐带血造血干细胞库 脐带血 法律法规 质量标准 国外标准 脐血库规范 

分 类 号：R331[医药卫生—人体生理学]