Mesenchymal Stromal Cells
| Autor: | Hematti Peiman, Sowmya Viswanathan |
|---|---|
| EAN: | 9780128028407 |
| eBook Format: | PDF/ePUB |
| Sprache: | Englisch |
| Produktart: | eBook |
| Veröffentlichungsdatum: | 11.08.2016 |
| Untertitel: | Translational Pathways to Clinical Adoption |
| Kategorie: | |
| Schlagworte: | CMC and reference materials academic center cGMP cell product characterization cell therapy cell therapy clinical trials cellular therapy clinical protocol clinical trial design donor variability economic evaluations efficacy engraftment |
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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