2015-新版-GMP标准制备间充质干细胞.pdf

Methods in Molecular Biology (2015) 1283: 171–186 DOI 10.1007/7651_2014_103 © Springer Science+Business Media New York 2014 Published online: 05 August 2014 n c 8. l l e c m e t s w. Standard Operating Procedure for the Good Manufacturing w w Practice-Compliant Production of Human Bone Marrow Mesenchymal Stem Cells n Livia Roseti, Marta Serra, and Alessandra Bassi c 8. l l e c m Abstract e t s w. According to the European Regulation (EC 1394/2007), Mesenchymal Stem Cells expanded in culture for w clinical use are considered as Advanced Therapy Medicinal Products. As a consequence, they must be w 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 implan- tation in humans. This procedure can be considered as a template for the development of investigational