title: Clinical grade expansion of MSCs.
abstract: Producing advanced therapy medicinal products (ATMP) according to Good Manufacturing Practice (GMP) guidelines represents a global challenge for the expansion of cells intended for human use. Mesenchymal stromal cells (MSCs) from different sources are one of the most actively developed cell type for a variety of clinical applications in cellular therapy. Complying with GMP means defining accurately both the production process and the release criteria required for a final safe product. We have here reported our manufacturing experience on 103 consecutive clinical-grade in vitro expansions of both bone marrow-derived and umbilical cord-derived mesenchymal stromal cells together with description of methods and reagents utilized in our Cell Factory. The same animal- and serum-free medium, additioned with human platelet lysate, has been used for all the expansions performed. This is the largest experience published so far with this alternative and clinical-grade reagent (compared to the traditional fetal bovine serum) and shows the feasibility and the reproducibility of the method. Indeed, we have been able to produce a sufficient number of MSCs to treat 57 patients so far, enrolled in 7 different experimental phase I/II protocols.
authors.affiliation: USS Centro di Terapia Cellulare "G. Lanzani", USC Haematology and Stem cells Transplantation, Azienda Ospedaliera Papa Giovanni XXIII, Piazza OMS, 1, 24124 Bergamo, Italy. Electronic address: capelli_chiara@hotmail.com.
authors.forename: C
authors.initials: C
authors.lastname: Capelli
authors.affiliation: USS Centro di Terapia Cellulare "G. Lanzani", USC Haematology and Stem cells Transplantation, Azienda Ospedaliera Papa Giovanni XXIII, Piazza OMS, 1, 24124 Bergamo, Italy.
authors.forename: O
authors.initials: O
authors.lastname: Pedrini
authors.affiliation: USS Centro di Terapia Cellulare "G. Lanzani", USC Haematology and Stem cells Transplantation, Azienda Ospedaliera Papa Giovanni XXIII, Piazza OMS, 1, 24124 Bergamo, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Valgardsdottir
authors.affiliation: USS Centro di Terapia Cellulare "G. Lanzani", USC Haematology and Stem cells Transplantation, Azienda Ospedaliera Papa Giovanni XXIII, Piazza OMS, 1, 24124 Bergamo, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Da Roit
authors.affiliation: USS Centro di Terapia Cellulare "G. Lanzani", USC Haematology and Stem cells Transplantation, Azienda Ospedaliera Papa Giovanni XXIII, Piazza OMS, 1, 24124 Bergamo, Italy.
authors.forename: J
authors.initials: J
authors.lastname: Golay
authors.affiliation: USS Centro di Terapia Cellulare "G. Lanzani", USC Haematology and Stem cells Transplantation, Azienda Ospedaliera Papa Giovanni XXIII, Piazza OMS, 1, 24124 Bergamo, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Introna
mesh_terms: D000818:Animals; D001854:Bone Marrow Cells / Q000166:cytology* / Q000378:metabolism; D018929:Cell Culture Techniques / Q000379:methods*; D049109:Cell Proliferation; D002478:Cells, Cultured; D006801:Humans; D016130:Immunophenotyping; D007621:Karyotyping; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods; D059630:Mesenchymal Stem Cells / Q000166:cytology* / Q000378:metabolism; D015203:Reproducibility of Results; D014470:Umbilical Cord / Q000166:cytology*
keywords: Cell therapy; Good manufacturing practices; Mesenchymal stromal cells