Abstract
Abstract
Background
Cell-based therapy products are supposed to be the most complex medicine products in the history of human medical care. In this study, we established a safety evaluation system for therapeutic stromal cells based on the existing regulations and current testing techniques to provide general quality requirements for human umbilical cord mesenchymal stromal cell (HUCMSC) therapy product.
Methods
In this system, we comprehensively evaluate the environmental monitoring program, quality control of critical raw materials and reagents, donor screening criteria, cell safety, quality, and biological effects, not only in line with the basic criteria of biological products, but also following the general requirements of drugs.
Results
The qualified HUCMSCs were tested for various clinical researches in our hospital, and no severe adverse reaction was observed in 225 patients during a 1-year follow-up period.
Conclusion
In this study, we establish a systemic quality control and potent assays to guarantee the safety and effectiveness of HUCMSCs based on a minimum set of standards in MSC-based product.
Funder
National Key Research and Development Program of China
National Natural Science Foundation of China
Nanjing Medical Science and technique Development Foundation
Nanjing Medical Science and Innovation Platform
Publisher
Springer Science and Business Media LLC
Subject
Cell Biology,Biochemistry, Genetics and Molecular Biology (miscellaneous),Molecular Medicine,Medicine (miscellaneous)
Reference38 articles.
1. Antunes MA, Laffey JG, Pelosi P, Rocco PRM. Mesenchymal stem cell trials for pulmonary diseases. J Cell Biochem. 2014;115:1023–32.
2. Williams AR, Hare JM. Mesenchymal stem cells: biology, pathophysiology, translational findings, and therapeutic implications for cardiac disease. Circ Res. 2011;109:923–40.
3. Drela K, Siedlecka A, Sarnowska A, Domanskajanik K. Human mesenchymal stem cells in the treatment of neurological diseases. Acta Neurobiol Exp (Wars). 2013;73:38–56.
4. Bovenberg MSS, Degeling MH, Tannous BA. Advances in stem cell therapy against gliomas. Trends Mol Med. 2013;19:281–91.
5. Kebriaei P, Saliba R, Rondon G, Chiattone A, Luthra R, Anderlini P, et al. Long-term follow-up of allogeneic hematopoietic stem cell transplantation for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia: impact of tyrosine kinase inhibitors on treatment outcomes. Biol Blood Marrow Transplant. 2012;18:584–92.
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