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Journal of Neurorestoratology  2020, Vol. 8 Issue (4): 197-216    doi: 10.26599/JNR.2020.9040021
Special Report     
Standards of clinical-grade mesenchymal stromal cell preparation and quality control (2020 China Version)
Shuanglin Xiang1,(✉)(),Wenyong Gao2,Haining Peng3,Aibing Liu4,Qiang Ao5,Manjun Yang3,Yanqiu Yu6,Ying Liu4,Raoxing Rong7,On behalf of Chinese Association of Neurorestoratology (Preparatory) and China Committee of International Association of Neurorestoratology
1 Landfar Bio-medicine Co., Ltd., Changsha 410015, Hunan, China
2 Beijing Hongtianji Neuroscience Academy, Beijing 100144, China
3 Hunan Landfar Amspring Biotechnology Co., Ltd., Changsha 410205, Hunan, China
4 Third Medical Center of General Hospital of PLA, Beijing 100039, China
5 Institute of Regulatory Science for Medical Device, National Engineering Research Center for Biomaterials, Sichuan University, Chengdu, Sichuan 610064, China
6 College of Basic Medical Sciences, China Medical University, Shenyang 110122, Liaoning, China
7 Shenyang Engineering Technology R&D Center of Cell Therapy Co., Ltd., Shenyang 110169, Liaoning, China
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Abstract  

Mesenchymal stromal cells (MSCs) including mesenchymal stem cells to potentially differentiate into different tissue lineages widely exist in various tissues. In recent years, the clinical research and application of MSCs have become more extensive, but no standardized guidelines for the preparation and quality control of clinical-grade MSCs currently exist. To standardize the preparation and quality control of MSCs using the human umbilical cord, placenta, bone marrow, and adipose tissue as sample sources for the Chinese Association of Neurorestoratology (CANR; Preparatory) and the China Committee of International Association of Neurorestoratology (IANR-China Committee) member units, this standard is formulated following the T11/CSSCR 001-2017 General Requirements for Stem Cells, Good Manufacturing Practice Pharmaceutical Products (2010 Edition), Pharmacopoeia of the People's Republic of China (2015 Edition), Guiding Principles for Quality Control of Stem Cell Preparations and Preclinical Research (Trial), Code for Cell Banking Facility Quality Management, Sterile Drug Appendix to Pharmaceutical Production Quality Management Regulations, GMP Appendix — Cell Therapy Products (Draft for Comment), The International Society for Cellular Therapy position statement (2006), and Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017). Moreover, this standard includes donor evaluation, sample collection, cell preparation, cell inspection, packaging, labeling, transportation and storage, and quality control. It represents the minimum requirements for clinical-grade mesenchymal stromal cell culture and quality control. Moreover, it will be further optimized following the progress of preclinical and clinical research.



Key wordsmesenchymal stromal cell      clinical-grade      preparation      quality control standard     
Received: 23 September 2020      Published: 07 February 2021
Corresponding Authors: Shuanglin Xiang     E-mail: xshlin@hunnu.edu.cn
Cite this article:

Shuanglin Xiang, Wenyong Gao, Haining Peng, Aibing Liu, Qiang Ao, Manjun Yang, Yanqiu Yu, Ying Liu, Raoxing Rong. Standards of clinical-grade mesenchymal stromal cell preparation and quality control (2020 China Version). Journal of Neurorestoratology, 2020, 8: 197-216.

URL:

http://jnr.tsinghuajournals.com/10.26599/JNR.2020.9040021     OR     http://jnr.tsinghuajournals.com/Y2020/V8/I4/197

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