Mesenchymal Stromal Cells: Translational Pathways to Clinical Adoption

ISBN-13: 9780128028261 / Angielski / Miękka / 2016 / 362 str.

Hematti Peiman; Sowmya Viswanathan

Opis

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.

• Provides methodologies for clinical MSC production, from designing a facility, to post-market approval
• Includes real-life examples of MSC production in academic centers and MSC production for biopharmaceutical clinical trials
• Offers a unique perspective on the clinical aspects of MSC studies
• Presents the principles of clinical trials that can be applied to the production of various cell therapies

Spis treści

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