title: Standard operating procedure for the good manufacturing practice-compliant production of human bone marrow mesenchymal stem cells.
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.
authors.affiliation: Dipartimento Rizzoli RIT-Research, Innovation and Technology, Cell Factory, Musculoskeletal Tissue Bank, PROMETEO, RAMSES Laboratory, Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136, Bologna, Italy, livia.roseti@ior.it.
authors.forename: Livia
authors.initials: L
authors.lastname: Roseti
authors.forename: Marta
authors.initials: M
authors.lastname: Serra
authors.forename: Alessandra
authors.initials: A
authors.lastname: Bassi
mesh_terms: D018929:Cell Culture Techniques / Q000379:methods* / Q000592:standards*; D019983:Guideline Adherence; D006801:Humans; D059630:Mesenchymal Stem Cells / Q000166:cytology* / Q000378:metabolism; D011786:Quality Control