title: MSC-based product characterization for clinical trials: an FDA perspective.
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.
authors: Office of the Commissioner (OC), Office of the Chief Scientist (OCS), Office of Regulatory Science and Innovation (ORSI), 10903 New Hampshire Boulevard, Silver Spring, MD 20993, USA; Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapy (OCTGT), Division of Cell and Gene Therapy (DCGT), 1401 Rockville Pike, Rockville, MD 20852, USA. Electronic address: m.mendicino.phd@gmail.com.
authors: Michael
authors: M
authors: Mendicino
authors: CBER, OCTGT, Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), 1401 Rockville Pike, Rockville, MD 20852, USA.
authors: Alexander M
authors: AM
authors: Bailey
authors: Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapy (OCTGT), Division of Cell and Gene Therapy (DCGT), 1401 Rockville Pike, Rockville, MD 20852, USA.
authors: Keith
authors: K
authors: Wonnacott
authors: Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapy (OCTGT), Division of Cell and Gene Therapy (DCGT), 1401 Rockville Pike, Rockville, MD 20852, USA.
authors: Raj K
authors: RK
authors: Puri
authors: Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapy (OCTGT), Division of Cell and Gene Therapy (DCGT), 1401 Rockville Pike, Rockville, MD 20852, USA. Electronic address: steven.bauer@fda.hhs.gov.
authors: Steven R
authors: SR
authors: Bauer
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D002462:Cell Membrane / Q000378:metabolism; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D006801:Humans; D059630:Mesenchymal Stem Cells / Q000166:cytology*; D057905:Stem Cell Research / Q000331:legislation & jurisprudence*; D014019:Tissue Donors; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D015415:Biomarkers