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

Affiliations

• ¹ 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.
• ² CBER, OCTGT, Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), 1401 Rockville Pike, Rockville, MD 20852, USA.
• ³ 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.
• ⁴ 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.