Standards of clinical-grade mesenchymal stromal cell preparation and quality control (2020 China Version)

Dominici, 2006, Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement, Cytotherapy, 8, 315, 10.1080/14653240600855905 National Health and Family Planning Commission, China Food and Drug Administration. Guiding Principles for Quality Control of Stem Cell Preparations and Preclinical Research (Trial). 2015. Chinese Society for Stem Cell Research, 2017 China Medicinal Biotechnology Association. Code for Cell Banking Facility Quality Management. 2017. Jiangsu Administration for Market Regulation. DB32/T3544-2019 Quality Control Technical Specifications Clinical Grade Mesenchymal Stem Cells from Human Tissues. 2019. Jones, 2008, Global trends in emerging infectious diseases, Nature, 451, 990, 10.1038/nature06536 Ministry of Health of the People's Republic of China. Good Manufacturing Practice for Pharmaceutical Products. 2010. National Medical Products Administration. GMP Appendix — Cell Therapy Products (Draft for Comment). 2019. Qiang, 2018, Standards for the culture and quality control of umbilical cord mesenchymal stromal cells for neurorestorative clinical application, J Neurorestoratology, 6, 11 State Food and Drug Administration. Sterile Drug Appendix to Pharmaceutical Production Quality Management Regulations. 2011. Huang, 2018, Clinical cell therapy guidelines for neurorestoration (IANR/CANR 2017), Cell Transplant, 27, 310, 10.1177/0963689717746999 Shenzhen Society for Cell Therapy Technology. SZTT/SSCT 002-2018 Product Specification of Human Umbilical Cord Derived Mesenchymal Stem Cell for Clinical Research. 2018. Chinese Pharmacopoeia Commission, 2015