MSC-based product characterization for clinical trials: an FDA perspective.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 24506881.
- Also identified by DOI 10.1016/j.stem.2014.01.013.
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Abstract
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.
Medical subject headings
- Clinical Trials as Topic
- Mesenchymal Stem Cells
- Stem Cell Research
- United States Food and Drug Administration