【摘要】 目的随着国内外干细胞学科临床研究的进展,为了提高我院干细胞临床研究水平,建立了标准化的干细胞临床研究实验室。方法基于《药品生产质量管理规范》《实验室生物安全通用要求》(GB19489)、《医院洁净手术部建筑技术规范的规定》(GB50333),结合我院的实际情况设计建设了该实验室,并进行了实验室的仪器和信息系统的配置。结果该实验室建设后运行近两年,成功实现了干细胞的制备、培养、质控及存储等功能,并利用信息系统实现了干细胞的检索和统计分析及可追溯性等功能,并成功通过了国家的干细胞基地现场验收。结论我院干细胞实验室的标准化建设,极大地促进了我院干细胞的临床研究水平,并为下一步我院干细胞临床项目顺利开展奠定了基础。更多还原

【Abstract】 Objective With the development of clinical research on stem cells at home and abroad, a standardized clinical research laboratory on stem cells has been established in order to improve the level of clinical research on stem cells in our hospital. Methods The laboratory was designed and constructed according to the actual situation of our hospital, which was based on the standard of quality management of drug production, the general requirements for laboratory biosafety(GB19489) and the regulations of building technical code of hospital clean operation department(GB50333). The equipment and information system of the laboratory were configured. Results The functions of stem cell preparation, cultivation, quality control and storage had been successfully realized after the construction of the laboratory for nearly two years. The retrieval, statistical analysis and traceability of stem cells were realized by the information system, and the national stem cell base had been successfully accepted. Conclusion The standardized construction of the stem cell laboratory in our hospital has greatly promoted the clinical research level of the stem cells in our hospital, and laid the foundation for the next step of the successful development of the stem cell clinical projects in our hospital.更多还原