MSC-based product characterization for clinical trials: an FDA perspective

Cell Stem Cell. 2014 Feb 6;14(2):141-5. doi: 10.1016/j.stem.2014.01.013.


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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Biomarkers / metabolism
  • Cell Membrane / metabolism
  • Clinical Trials as Topic / legislation & jurisprudence*
  • Humans
  • Mesenchymal Stem Cells / cytology*
  • Stem Cell Research / legislation & jurisprudence*
  • Tissue Donors
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence*


  • Biomarkers