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...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 Peopleʹs 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.and consumables that are directly in contact with the cells should be opened and operated in a Grade An environment with a Grade B background[8,10].7.3.5 Samples from different donors or different batches should not be processed continuously in the same operation area to avoid cross-contamination.The workplace should be cleared,and normal ultraviolet disinfection should be carried out after a sample is processed[8].7.3.6 The donorʹs MSC culture shall be managed in a multilevel graded bank(premaster,master,and working cell banks).The cell bank for cellular preparations may be established according to actual conditions[4].7.3.7 After the cell culture in the premaster cell bank is completed according to the actual situation,the peripheral blood of the donor or the donorʹs mother may be collected again for serological testing 3–6 months after the sample collection.Infectious and genetic diseases are followed up.Cell culture for the remaining graded banks is performed after the test and follow-up results meet the requirements.7.3.8 The cell generation of the cell-based medicinal products shall not exceed the maximum allowed by the cell culture process.7.3.9 Cryopreservation of intermediate/final products of cellular preparations in the cell bank requires gradient or program cooling.展开更多
文摘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 Peopleʹs 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.and consumables that are directly in contact with the cells should be opened and operated in a Grade An environment with a Grade B background[8,10].7.3.5 Samples from different donors or different batches should not be processed continuously in the same operation area to avoid cross-contamination.The workplace should be cleared,and normal ultraviolet disinfection should be carried out after a sample is processed[8].7.3.6 The donorʹs MSC culture shall be managed in a multilevel graded bank(premaster,master,and working cell banks).The cell bank for cellular preparations may be established according to actual conditions[4].7.3.7 After the cell culture in the premaster cell bank is completed according to the actual situation,the peripheral blood of the donor or the donorʹs mother may be collected again for serological testing 3–6 months after the sample collection.Infectious and genetic diseases are followed up.Cell culture for the remaining graded banks is performed after the test and follow-up results meet the requirements.7.3.8 The cell generation of the cell-based medicinal products shall not exceed the maximum allowed by the cell culture process.7.3.9 Cryopreservation of intermediate/final products of cellular preparations in the cell bank requires gradient or program cooling.
