协和医学杂志

2019, v.10(02) 172-177

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临床级干细胞库的建设与管理
Construction and Management of Stem Cell Banks of the Clinical Grade

周红梅;
ZHOU Hong-mei;Biobank,East Hospital Affiliated to Tongji University;

摘要(Abstract):

近年来,干细胞在疾病治疗、组织修复、抗衰美容等多个领域均展现出极大的发展潜力与广阔的临床应用前景,已成为生命科学的重要研究方向之一,受到全球范围的广泛关注。优质的临床级干细胞库既是干细胞产品进入临床的前提条件,也是干细胞行业成功的关键要素,必将为干细胞临床研究提供不可或缺的资源。本文结合我国国情和同济大学附属东方医院在临床级干细胞库建设与管理方面的实践与探索经验,重点阐述临床级干细胞库的规划、建设与全流程链管理,涵盖采集、制备、检验、冷冻保存、分发、质量管理体系的建立以及干细胞生命周期信息追踪与数据管理等,以供同行借鉴。
In recent years,research on stem cell has made great progression and widespread clinical application in disease treatments,tissue repair,anti-aging,cosmetology,and other fields. It has become one of the most important researching directions in the field of life science,and has been widely concerned around the world. A high-quality stem cell bank of the clinical grade is not only the precondition for stem cell products to enter clinical practice,but also the key factor for the success of the stem cell industry. Besides,it will provide an indispensable resource for the clinical research of stem cells. Based on the situation of our country and the practice and exploration experience of construction and management of a clinical stem cell bank of East Hospital Affiliated to Tongji University,the article focuses on the planning,construction,and the management of a whole process chain of a stem cell bank of the clinical grade,and covers collection,preparation,testing,cryopreservation,distribution,the establishment of a quality management system,information tracking,and data management of stem cell lifecycle.

关键词(KeyWords): 临床级干细胞库;存储;交叉污染;干细胞制备;质量管理体系;信息追踪
stem cell bank of the clinical grade;storage;cross contamination;stem cell preparation;quality management system;information traceability

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划(2016YFA0101300)

作者(Author): 周红梅;
ZHOU Hong-mei;Biobank,East Hospital Affiliated to Tongji University;

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