Hematti Peiman,
Sowmya Viswanathan
Elsevier Science
e druk, 2016
9780128028261
Mesenchymal Stromal Cells
Translational Pathways to Clinical Adoption
Specificaties
Paperback, blz.
|
Engels
Elsevier Science |
2016
ISBN13: 9780128028261
Rubricering
Levertijd ongeveer 9 werkdagen
Gratis verzonden
Samenvatting
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.
Specificaties
Inhoudsopgave
<p>Preface<br>Armand Keating</p> <p>1. MSCs Translational Process<br>Sowmya Viswanathan, Amin Adibi and Shashank Bhatt</p> <p>2. Preclinical Animal Testing Requirements and Considerations<br>John M. Centanni</p> <p>3. Delivery and Tracking Considerations for Cell Based Therapies<br>Eric G. Schmuck and Amish N. Raval</p> <p>4. Allogeneic Versus Autologous Mesenchymal Stromal Cells and Donor to Donor Variability<br>Muna Qayed, Ian Copland, Jacques Galipeau</p> <p>5. Mesenchymal Stromal Cell Production in Academic Centers: Challenges and Opportunities<br>David H. McKenna</p> <p>6. Bioreactor for Scale-Up: Process Control<br>Eytan Abraham, Siddharth Gupta, Sunghoon Jung, Erika McAfee</p> <p>7. GMP Requirements<br>Adrian P. Gee</p> <p>8. Mesenchymal Stromal Cells and the Approach to Clinical Trial Design: Lessons Learned From Graft Versus Host Disease<br>Neil Dunavin, A. John Barrett & Minoo Battiwalla</p> <p>9. Regulatory Pathway for Mesenchymal Stromal Cell-based Therapy in the United States<br>Robert Lindblad, Ashraf El Fiky, Deborah Wood, Gillian Armstrong Miller</p> <p>10. Global Regulatory Perspective for MSCs<br>Anthony Lodge, Giulia Detela, Jacqueline Barry, Patrick Ginty and Natalie Mount</p> <p>11. The health economics for regenerative medicine: how payers think and what that means for developers<br>Christopher McCabe and Tania Bubela</p> <p>12. Mesenchymal stromal cells: Clinical experience, challenges and future directions<br>Peiman Hematti<br></p>