Cell Stem Cell
Volume 14, Issue 2, 6 February 2014, Pages 141-145
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MSC-Based Product Characterization for Clinical Trials: An FDA Perspective

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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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