title: FDA regulation of adult stem cell therapies as used in sports medicine.
abstract: In sports medicine, adult stem cells are the subject of great interest. Several uses of stem cells are under investigation including cartilage repair, meniscal regeneration, anterior cruciate ligament reconstruction, and tendinopathy. Extensive clinical and basic science research is warranted as stem cell therapies become increasingly common in clinical practice. In the United States, the Food and Drug Administration (FDA) is responsible for regulating the use of stem cells through its "Human Cells, Tissues, and Cellular and Tissue-Based Products" regulations. This report provides a brief overview of FDA regulation of adult stem cells. Several common clinical case scenarios are then presented that highlight how stem cells are currently being used in sports medicine and how current FDA regulations are likely to affect the physicians who use them. In the process, it explains how a variety of factors in sourcing and handling these cells, particularly the extent of cell manipulation, will affect what a physician can and cannot do without first obtaining the FDA's express approval.
authors.affiliation: Boston College Law School, Newton Centre, Massachusetts.
authors.forename: Mary Ann
authors.initials: MA
authors.lastname: Chirba
authors.affiliation: Boston College Law School, Newton Centre, Massachusetts.
authors.forename: Berkley
authors.initials: B
authors.lastname: Sweetapple
authors.affiliation: Georgetown University School of Medicine, Washington, District of Columbia.
authors.forename: Charles P
authors.initials: CP
authors.lastname: Hannon
authors.affiliation: Department of Sports Medicine, Rothman Institute, Philadelphia, Pennsylvania.
authors.forename: John A
authors.initials: JA
authors.lastname: Anderson
mesh_terms: D000328:Adult; D053687:Adult Stem Cells; D006801:Humans; D013178:Sports Medicine / Q000331:legislation & jurisprudence*; D033581:Stem Cell Transplantation / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*