Volume 10 Issue 2
Sep.  2020
Turn off MathJax
Article Contents
Hong-mei ZHOU. Construction and Management of Stem Cell Banks of the Clinical Grade[J]. Medical Journal of Peking Union Medical College Hospital, 2019, 10(2): 172-177. doi: 10.3969/j.issn.1674-9081.2019.02.017
Citation: Hong-mei ZHOU. Construction and Management of Stem Cell Banks of the Clinical Grade[J]. Medical Journal of Peking Union Medical College Hospital, 2019, 10(2): 172-177. doi: 10.3969/j.issn.1674-9081.2019.02.017

Construction and Management of Stem Cell Banks of the Clinical Grade

doi: 10.3969/j.issn.1674-9081.2019.02.017
  • Received Date: 2018-08-10
  • Publish Date: 2020-09-18
  • 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.
  • loading
  • [1] 中国产业调研网.中国干细胞医疗市场现状调研与发展前景分析报告(2018-2025年)[EB/OL].http://www. cir. cn/R_ YiYaoBaoJian/20/GanXiBaoYiLiaoFaZhanXian ZhuangFenXiQianJingYuCe.html.
    [2] 裴雪涛.干细胞产业化发展现状、瓶颈及展望[EB/OL].https://www.360zhyx.com/home-research-index-rid-64539.shtml.
    [3] Takahashi K, Yamanaka S.Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors[J].Cell, 2006, 126:663-676. doi:  10.1016/j.cell.2006.07.024
    [4] Newsha H, Mohammad P, Parvaneh F, et al.Stem Cell Banking in Iran[M].New York: Springer, 2014: 123-141.
    [5] Torsvik A, Rosland GV, Svendsen A, et al. Spontaneous malignant transformation of human mesenchymal stem cells reflects cross-contamination: putting the research field ontrack[J]. Cancer Res, 2010, 70:6393-6396. doi:  10.1158/0008-5472.CAN-10-1305
    [6] Hughes P, Marshall D, Reid Y, et al. The costs of using unauthenticated, over-passaged cell lines:how much more data do we need?[J]. Biotechniques, 2007, 43:575-583. doi:  10.2144/000112598
    [7] Masters JR. False cell lines: the problem and the solution[J]. Cytotechnology, 2002, 39:69-74. doi:  10.1023/A:1022908930937
    [8] Wrigley JD, McCall EJ, Bannaghan CL, et al.Cell banking for pharmaceuticalresearch[J].Drug Discov Today, 2014, 19:1518-1529. doi:  10.1016/j.drudis.2014.05.006
    [9] Kimmelman J, Heslop HE, Sugarman J, et al.New ISSCR guidelines: clinical translation of stem cellresearch[J].Lancet, 2016, 387:1979-1981. doi:  10.1016/S0140-6736(16)30390-7
    [10] 国务院.人类遗传资源管理暂行办法[EB/OL].http://www.gene.gov.cn/news/7643806.html.
    [11] 国家卫生计生委, 国家食品药品监管总局.干细胞临床研究管理办法(试行)[EB/OL].http://www.nhfpc.gov.cn/ qjjys/s3581/201508/28635ef99c5743e294f45e8b29c72309.shtml.
    [12] 中国工程电子设计院.洁净厂房设计规范GB50073-2013[EB/OL].http://www.jhgc-kwt.com/mingci/950.html.
    [13] 国家食品药品监督管理局.关于贯彻实施《药品生产质量管理规范(2010年修订)》的通知[EB/OL].http://samr.cfda.gov.cn/WS01/CL0844/59017.html.
    [14] 郜恒骏, 周学迅, 张小燕, 等.ISBER最佳实践2018[J].中国医药生物技术, 2018, 13(增刊):1-54.
    [15] 王太平, 徐国彤, 周琪, 等.国际干细胞研究学会《干细胞临床转化指南》[J].生命科学, 2009, 21:747-756. http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=smkx200905026
    [16] 祝贺, 郝捷, 周琪, 等.临床级干细胞库及干细胞制剂[J].生命科学, 2016, 28:895-901. http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=smkx201608013
    [17] International Stem Cell Banking Initiative.Consensus guid-ance for banking and supply of humanembryonic stem cell lines for research purposes[J].Stem Cell Rev, 2009, 5:301-314. doi:  10.1007/s12015-009-9085-x
    [18] 国家卫生计生委办公厅, 食品药品监管总局办公厅.干细胞制剂质量控制及临床前研究指导原则(试行)[EB/OL].https: //bbs.iiyi.com/thread-2619912-1.html.
    [19] Fisher M.ISBT 128—a new international standard for labelling and data management blood transfusion[J]. Transfus Sci, 1995, 16:249-254. doi:  10.1016/0955-3886(95)00030-2
    [20] Froud SJ.Cell Bank Preparation and Characterization[M].New Jersey: Humana Press, 1999: 99-115.
    [21] Sun C, Yue J, He N, et al.Fundamental Principles of Stem Cell Banking[J]. Adv Exp Med Biol, 2016, 951:31-45. http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=35677b54d4777aa3b38d8eb897178c2e
    [22] 国家药典委员会.中华人民共和国药典[M].北京: 中国医药科技出版社, 2012: 附录190-191.
    [23] FACT-JACIE.International Standards for Cellular Therapy Product Collection, Processing, and Administration for Hematopoietic Cellular Therapies[EB/OL]. https: //www.docin.com/p-1003220446.html& dpage=1& key.
    [24] 赵庆辉, 周红梅, 穆会玲, 等.干细胞资源库及信息管理系统的标准化建设[J].转化医学杂志, 2018, 7:17-19. http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=zhyxzz201801005
  • 加载中

Catalog

    通讯作者: 陈斌, bchen63@163.com
    • 1. 

      沈阳化工大学材料科学与工程学院 沈阳 110142

    1. 本站搜索
    2. 百度学术搜索
    3. 万方数据库搜索
    4. CNKI搜索

    Article Metrics

    Article views (493) PDF downloads(297) Cited by()
    Proportional views
    Related

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return