MSC-Based Product Characterization for Clinical Trials: An FDA Perspective
| Autor: | Keith Wonnacott, Steven R. Bauer, Michael Mendicino, Alexander M. Bailey, Raj K. Puri |
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| Jazyk: | angličtina |
| Předmět: |
Clinical Trials as Topic
Rapid expansion United States Food and Drug Administration Cell Membrane Mesenchymal Stem Cells Cell Biology Pharmacology Biology Stem Cell Research Tissue Donors United States Clinical trial Characterization methods Risk analysis (engineering) Genetics Molecular Medicine Humans Product (category theory) Biomarkers |
| Zdroj: | Cell Stem Cell. (2):141-145 |
| ISSN: | 1934-5909 |
| DOI: | 10.1016/j.stem.2014.01.013 |
| Popis: | Proposals submitted to the FDA for MSC-based products are undergoing a rapid expansion that is characterized by increased variability in donor and tissue sources, manufacturing processes, proposed functional mechanisms, and characterization methods. Here we discuss the diversity in MSC-based clinical trial product proposals and highlight potential challenges for clinical translation. |
| Databáze: | OpenAIRE |
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