EFS Pyrénées-Méditerranée, Toulouse, EFS Centre-Atlantique, Tours, Inserm ESPRI-EA3855, Tours, Société française de greffe de moelle et thérapie cellulaire (SFGM-TC)
Mesenchymal Stem Cells (MSCs) are multipotent adult stem cells with a wide range of differentiation and having an immunosuppressive effect. All these functions will lead to an increasing use of MSC in the graft process or in the regenerative medicine. For the production of MSCs in clinical trials, standards are required. This kind of production necessitates adhering to good manufacturing practices to insure the delivery of a “cell drug” that is safe, reproducible, and efficient. All parts of the process must be defined, specifically the starting material (tissue origin, separation or enrichment procedures), cell density in culture, and medium (fetal calf serum [FCS] or human serum, cytokines with serum-free medium for target). But to reach the good manufacturing practices goal, cells need to be cultured in as close to a closed system as possible. Analytical methods are needed to assay the active compound and impurities. At a minimum, quality control of cells must consider the phenotype, functional potential and microbiological safety. Finally, quality assurance system procedures specific to the production of MSCs as a cell drug must be determined and implemented. In accordance with these goals, a clinical scale production of MSCs was implemented by SFGM-TC.