Isolation and Manufacture of Clinical-Grade Bone Marrow-Derived Human Mesenchymal Stromal Cells
Mesenchymal stromal cells (MSCs) are multipotent cells with both regenerative and immunomodulatory capacities. These unique properties make them appealing as a biologic, with multiple phase 1–3 clinical trials currently testing their safety and efficacy. Although expanding MSCs does not require extensive manipulation, expanding MSCs for use in clinical trials does require the knowledge and safety that are delineated in current good manufacturing practices (GMPs). Here we briefly detail the characteristics of MSCs and considerations for expanding them for clinical use. We then include a step-by-step protocol for expanding MSCs for early phase clinical trials, with important notes to consider during the expansion of these MSCs.
Key wordsMesenchymal stromal cells Clinical grade Good manufacturing practices Cell therapy
The authors would like to thank our collaborators at the Baylor College of Medicine, namely, Dr. Adrian Gee, Dr. Zhuyong Mei, and Dr. Helen Heslop. We would also like to thank the Program for Cell Enhancement and Technologies for Immunotherapy (CETI) director, Dr. Catherine Bollard, for her support and guidance.