FDA Regulation of Stem Cell–Based Products
Donald W. Fink, Jr.
Cell self-renewal and the capacity to differentiate into multiple
cell types (pluripotency) are biological attributes casting
stem cells as attractive candidates for development of therapies
targeting indications that involve functional restoration of
damaged tissues. In the United States, clinical trials designed
to demonstrate the safety and effectiveness of stem cell–based
products are regulated by the U.S. Food and Drug Administration
(FDA). To ensure that subjects enrolled in a clinical study
involving stem cell–based products are not exposed to
significant and unreasonable risk, the FDA reviews medical and
scientific information that encompasses delineation of product-specific
characteristics and preclinical testing to determine whether
there is sufficient safety assurance to permit initiation of
human clinical studies.
E-mail: donald.fink{at}fda.hhs.gov
