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

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

Michael Mendicino  1 , Alexander M Bailey  2 , Keith Wonnacott  3 , Raj K Puri  3 , Steven R Bauer  4
Affiliations
Free article

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

Michael Mendicino et al. Cell Stem Cell. .
Free article

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.

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