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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
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 facilities
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
- No. of pages:
- © Academic Press 2016
- 9th August 2016
- Academic Press
- Paperback ISBN:
- eBook ISBN:
Dr. Peiman Hematti joined the Section of Hematology/Bone Marrow Transplantation at the University of Wisconsin-Madison in July 2004 as an Assistant Professor in the Department of Medicine. Dr. Hematti has completed a combined Internal Medicine/Pediatrics residency at the Cleveland Clinic Foundation and then Hematology fellowship at the National Heart, Lung and Blood Institute at the National Institutes of Health. His clinical interests are in inpatient care of hematopoietic stem cell transplant patients. He is the director of the clinical hematopoietic cell processing laboratory, and in that capacity oversees all the peripheral blood stem cell collections from the patients and processing of their products.
Associate Professor of Medicine, Pediatrics, Surgery and Biomedical Engineering; Director, Clinical Hematopoietic Cell Processing Laboratory; Director, Bone Marrow Collection, Apheresis and Processing Center, UW-Hospital andClinics; Department of Medicine, Division of Hematology/Oncology, University of Wisconsin-Madison School of Medicine and Public Health, University of Wisconsin Carbone Cancer Center, Wisconsin Institutes for Medical Research, Madison, WI, USA
Dr. Viswanathan has 10 years of experience leading multi-disciplinary teams of translational researchers, clinicians, nurses, manufacturing technicians, quality assurance manager, IT programmers and project managers who translate cell-based research into clinical trials. She specializes in commercial product development of biologics with specific expertise in stem cell translational research, preclinical pharmacology, GMP-compliant cell manufacturing of cell-based products, and working with regulatory agencies. She is currently Associate Director of the Cell Therapy Program at University Health Network in Toronto where she oversees the scientific, strategic, operational, regulatory, quality, pre-clinical strategy for the development of clinical-grade cells. In addition, Dr. Viswanathan works with the Center for Commercialization of Regenerative Medicine (CCRM), leading a vision for a Canada-wide national clinical program network, CellCan, that will concentrate on harmonizing practices, sharing strategies for clinical manufacturing of stem cells in Canada.
Associate Director, Cell Therapy Program, University Health Network, Toronto, ON, Canada
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