Mesenchymal Stromal Cells: Translational Pathways to Clinical Adoption
Editat de Hematti Peiman, Sowmya Viswanathanen Limba Engleză Paperback – 8 aug 2016
- 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
Preț: 510.54 lei
Preț vechi: 561.04 lei
-9% Nou
Puncte Express: 766
Preț estimativ în valută:
97.71€ • 103.08$ • 81.43£
97.71€ • 103.08$ • 81.43£
Carte tipărită la comandă
Livrare economică 26 decembrie 24 - 09 ianuarie 25
Preluare comenzi: 021 569.72.76
Specificații
ISBN-13: 9780128028261
ISBN-10: 0128028262
Pagini: 362
Dimensiuni: 191 x 235 x 19 mm
Greutate: 0.63 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0128028262
Pagini: 362
Dimensiuni: 191 x 235 x 19 mm
Greutate: 0.63 kg
Editura: ELSEVIER SCIENCE
Public țintă
Primary investigators across biomedical sciences using stem cells in clinical trials; biomedical researchers working on stem cell therapies; laboratory directors and technicians in cell production facilitiesCuprins
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
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