Mesenchymal Stromal Cells

Preface Armand Keating 1. MSCs Translational Process Sowmya Viswanathan, Amin Adibi and Shashank Bhatt 2. Preclinical Animal Testing Requirements and Considerations John M. Centanni 3. Delivery and Tracking Considerations for Cell Based Therapies Eric G. Schmuck and Amish N. Raval 4. Allogeneic Versus Autologous Mesenchymal Stromal Cells and Donor to Donor Variability Muna Qayed, Ian Copland, Jacques Galipeau 5. Mesenchymal Stromal Cell Production in Academic Centers: Challenges and Opportunities David H. McKenna 6. Bioreactor for Scale-Up: Process Control Eytan Abraham, Siddharth Gupta, Sunghoon Jung, Erika McAfee 7. GMP Requirements Adrian P. Gee 8. Mesenchymal Stromal Cells and the Approach to Clinical Trial Design: Lessons Learned From Graft Versus Host Disease Neil Dunavin, A. John Barrett & Minoo Battiwalla 9. Regulatory Pathway for Mesenchymal Stromal Cell-based Therapy in the United States Robert Lindblad, Ashraf El Fiky, Deborah Wood, Gillian Armstrong Miller 10. Global Regulatory Perspective for MSCs Anthony Lodge, Giulia Detela, Jacqueline Barry, Patrick Ginty and Natalie Mount 11. The health economics for regenerative medicine: how payers think and what that means for developers Christopher McCabe and Tania Bubela 12. Mesenchymal stromal cells: Clinical experience, challenges and future directions Peiman Hematti