Full Description
Mesenchymal Stromal Cells: Translational Pathways to Clinical Adoption provides the latest information on the necessary steps for successful production of stem cells for a clinical trial. Written by professionals with hands-on experience in bringing MSC therapies to the clinic, and building on the biology and mechanisms of action, this unique book covers the development and production of clinical-grade products that are suitable for use in humans. From design of a cell production facility, to obtaining regulatory approval and reimbursement issues, it is a useful guide for researchers and administrators across biomedical research.
Contents
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
