A number of studies have shown the role of expanded Bone Marrow-derived Mesenchymal Stem Cells in the repair and regeneration of musculo-skeletal tissues. The current European regulations define in vitro expanded cells for clinical purposes as substantially manipulated and include them in the class of Advanced-Therapy Medicinal Products to be manufactured in compliance with current Good Manufacturing Practice. Among the characteristics that such cells should display, genomic stability has recently become a major safety concern. The aim of this study is to perform a chromosomal and genetic characterization of Bone Marrow-derived Mesenchymal Stem Cells expanded in compliance with Good Manufacturing Practice for a potential clinical use in orthopaedics.
Roseti, L., Serra, M., Canella, F., Munno, C., Tosi, A., Zuntini, M., et al. (2014). In vitro gene and chromosome characterization of expanded bone marrow mesenchymal stem cells for musculo-skeletal applications. EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 18(23), 3702-3711.
In vitro gene and chromosome characterization of expanded bone marrow mesenchymal stem cells for musculo-skeletal applications
BINI, CARLA;PELOTTI, SUSI;Gasbarrini, A;
2014
Abstract
A number of studies have shown the role of expanded Bone Marrow-derived Mesenchymal Stem Cells in the repair and regeneration of musculo-skeletal tissues. The current European regulations define in vitro expanded cells for clinical purposes as substantially manipulated and include them in the class of Advanced-Therapy Medicinal Products to be manufactured in compliance with current Good Manufacturing Practice. Among the characteristics that such cells should display, genomic stability has recently become a major safety concern. The aim of this study is to perform a chromosomal and genetic characterization of Bone Marrow-derived Mesenchymal Stem Cells expanded in compliance with Good Manufacturing Practice for a potential clinical use in orthopaedics.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
