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.
1. Cover - p. i 2. Title page - p. iii 3. Table of Contents - p. iii 4. Copyright - p. ii 5. Dedication - p. iv 6. Contributors - p. v 7. Foreword - p. xvii 8. Chapter 1: MSCs Translational Process - p. xix 9. Chapter 2: Preclinical Animal Testing Requirements and Considerations - p. 35 10. Chapter 3: Delivery and Tracking Considerations for Cell-Based Therapies - p. 60 11. Chapter 4: Allogeneic Versus Autologous Mesenchymal Stromal Cells and Donor-to-Donor Variability - p. 96 12. Chapter 5: Mesenchymal Stromal Cell Production in Academic Centers: Challenges and Opportunities - p. 120 13. Chapter 6: Bioreactor for Scale-Up: Process Control - p. 138 14. Chapter 7: GMP Requirements - p. 177 15. Chapter 8: Mesenchymal Stromal Cells and the Approach to Clinical Trial Design: Lessons Learned From Graft Versus Host Disease - p. 201 16. Chapter 9: Regulatory Pathway for Mesenchymal Stromal Cell-Based Therapy in the United States - p. 225 17. Chapter 10: Global Regulatory Perspective for MSCs - p. 242 18. Chapter 11: The Health Economics for Regenerative Medicine: How Payers Think and What That Means for Developers - p. 287 19. Chapter 12: Mesenchymal Stromal Cells: Clinical Experience, Challenges, and Future Directions - p. 307 20. Index - p. 334
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.
1. Cover - p. i 2. Title page - p. iii 3. Table of Contents - p. iii 4. Copyright - p. ii 5. Dedication - p. iv 6. Contributors - p. v 7. Foreword - p. xvii 8. Chapter 1: MSCs Translational Process - p. xix 9. Chapter 2: Preclinical Animal Testing Requirements and Considerations - p. 35 10. Chapter 3: Delivery and Tracking Considerations for Cell-Based Therapies - p. 60 11. Chapter 4: Allogeneic Versus Autologous Mesenchymal Stromal Cells and Donor-to-Donor Variability - p. 96 12. Chapter 5: Mesenchymal Stromal Cell Production in Academic Centers: Challenges and Opportunities - p. 120 13. Chapter 6: Bioreactor for Scale-Up: Process Control - p. 138 14. Chapter 7: GMP Requirements - p. 177 15. Chapter 8: Mesenchymal Stromal Cells and the Approach to Clinical Trial Design: Lessons Learned From Graft Versus Host Disease - p. 201 16. Chapter 9: Regulatory Pathway for Mesenchymal Stromal Cell-Based Therapy in the United States - p. 225 17. Chapter 10: Global Regulatory Perspective for MSCs - p. 242 18. Chapter 11: The Health Economics for Regenerative Medicine: How Payers Think and What That Means for Developers - p. 287 19. Chapter 12: Mesenchymal Stromal Cells: Clinical Experience, Challenges, and Future Directions - p. 307 20. Index - p. 334
