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CHEN Cuizhu, HUANG Changfa, LI Qian, WU Ze, CAO Chunran, WU Zhihong. Microbial Contamination Control and Management of Human-derived Stem Cell Preparations and Related Regulations[J]. Medical Journal of Peking Union Medical College Hospital. DOI: 10.12290/xhyxzz.2024-0586
Citation: CHEN Cuizhu, HUANG Changfa, LI Qian, WU Ze, CAO Chunran, WU Zhihong. Microbial Contamination Control and Management of Human-derived Stem Cell Preparations and Related Regulations[J]. Medical Journal of Peking Union Medical College Hospital. DOI: 10.12290/xhyxzz.2024-0586
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Microbial Contamination Control and Management of Human-derived Stem Cell Preparations and Related Regulations

  • 1 Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College;

  • 2 State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College;

  • 3 Department of Orthopaedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China;

  • 4 Graduate School, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China;

  • 5 Beijing Institute for Drug Control, Key Laboratory for Safety Research and Evaluation of Innovative Drugs, State Drug Administration, Beijing 102206, China

Funds: 

Medical and Health Science and Technology Innovation Project of Chinese Academy of Medical Sciences(2021-2M-1-052）

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  • Received Date: July 27, 2024
  • Accepted Date: September 01, 2024
  • Available Online: December 09, 2024
    Graphical Abstract
    • Abstract
  • Stem cell preparations and associated products have been widely used in clinical trials and treatment of refractory diseases at home and abroad. Due to the complex preparation process of stem cell preparations, the current microbial examination methods are difficult to meet the relevant needs of safety testing of stem cell preparations, especially the release examination in medical institutions. It is urgent to develop new methods to make stem cell preparations safe and timely for clinical use. This article elaborates on the control process and standards for microbial contaminating in human stem cell preparations, covering raw material selection, preparation processes, release testing, clinical application and sample retention. The aim is to provide a basis for microbial quality control in the clinical application of stem cell preparations.
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    • References (54)
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