Overview
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
- | Author: Hematti Peiman, Sowmya Viswanathan
- | Publisher: Academic Press
- | Publication Date: Aug 11, 2016
- | Number of Pages: 362 pages
- | Language: English
- | Binding: Paperback
- | ISBN-10: 0128028262
- | ISBN-13: 9780128028261