Abstract
According to the European Regulation (EC 1394/2007), Mesenchymal Stem Cells expanded in culture for clinical use are considered as Advanced Therapy Medicinal Products. As a consequence, they must be produced in compliance with Good Manufacturing Practice in order to ensure safety, reproducibility, and efficacy. Here, we report a Standard Operating Procedure describing the Good Manufacturing Practice-compliant production of Bone Marrow-derived Mesenchymal Stem Cells suitable for autologous implantation in humans. This procedure can be considered as a template for the development of investigational medicinal Mesenchymal Stem Cells-based product protocols to be enclosed in the dossier required for a clinical trial approval. Possible clinical applications concern local uses in the regeneration of bone tissue in nonunion fractures or in orthopedic and maxillofacial diseases characterized by a bone loss.
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Acknowledgments
This work was supported by the grant “Progetto di Medicina Rigenerativa” from “Regione Emilia Romagna” (Delibera di Giunta n. 2233/2008).
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Roseti, L., Serra, M., Bassi, A. (2014). Standard Operating Procedure for the Good Manufacturing Practice-Compliant Production of Human Bone Marrow Mesenchymal Stem Cells. In: Turksen, K. (eds) Stem Cells and Good Manufacturing Practices. Methods in Molecular Biology, vol 1283. Humana Press, New York, NY. https://doi.org/10.1007/7651_2014_103
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DOI: https://doi.org/10.1007/7651_2014_103
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