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Mesenchymal Stromal Cells
Translational Pathways to Clinical Adoption
Need-to-know information for clinical production and therapeutic applications of MSCs and the production of stem cells for clinical trials
Hematti Peiman (Edited by), Sowmya Viswanathan (Edited by)
9780128028261, Elsevier Science
Paperback, published 9 August 2016
362 pages
23.4 x 19 x 2.3 cm, 0.77 kg
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.
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
Subject Areas: Biotechnology [TCB], Cellular biology [cytology PSF], Pharmacology [MMG], Clinical trials [MBGR1]
