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Cell Stem Cell 2014 Feb 6;14(2):141-5

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

Mendicino M, Bailey AM, Wonnacott K, Puri RK, Bauer SR

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.

Category: Journal Article
PubMed ID: #24506881 DOI: 10.1016/j.stem.2014.01.013
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2014-02-11
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