MSC-Based Product Characterization for Clinical Trials: An FDA Perspective

MSC-Based Product Characterization for Clinical Trials: An FDA Perspective

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 clinica...

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Veröffentlicht in:Cell stem cell 2014-02, Vol.14 (2), p.141-145
Hauptverfasser: Mendicino, Michael, Bailey, Alexander M., Wonnacott, Keith, Puri, Raj K., Bauer, Steven R.
Format: Artikel
Sprache:eng
Schlagworte:
Biomarkers - metabolism
Cell Membrane - metabolism
Clinical Trials as Topic - legislation & jurisprudence
Humans
Mesenchymal Stromal Cells - cytology
Stem Cell Research - legislation & jurisprudence
Tissue Donors
United States
United States Food and Drug Administration - legislation & jurisprudence
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Zusammenfassung: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.
ISSN:1934-5909
1875-9777
DOI:10.1016/j.stem.2014.01.013