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FDA Regulation of Stem Cell-Based Therapies
Full Title
FDA regulation of stem cell-based therapies
Summary
This article reviews the FDAâs stance on the use of stem cellâbased therapies, especially for musculoskeletal conditions. The authors note that many clinics market unapproved stem cell injections for orthopedic use, despite the lack of evidence on safety or effectiveness. The only FDA-approved stem cell treatments are for hematologic (blood) disorders. The article cautions that injecting stem cells for soft tissue injuries carries risks such as infection, abnormal cell behavior, and lack of therapeutic effect. It warns patients and providers to be skeptical of unproven regenerative therapies sold under misleading claims.