Orthopedic Applications of Stem Cell Therapy (Including Allografts and Bone Substitutes Used with Autologous Bone Marrow)

This policy addresses orthopedic applications of stem cell therapy—including isolation/use of autologous mesenchymal stem cells (MSCs), FDA‑cleared demineralized bone matrix (DBM) products, HCT/Ps, and allografts or bone substitutes used with autologous bone marrow. It applies to conditions such as knee osteoarthritis, focal cartilage/osteochondral defects and perioperative uses (e.g., HTO with microfracture), but broadly considers MSC therapies and allograft products marketed as containing viable stem cells experimental/investigational and only permits HCT/Ps that meet FDA criteria for minimal manipulation, homologous use, and allowed combinations, while engineered/expanded MSC products require regulatory approval.

"Isolation of mesenchymal stem cells (MSCs) from bone-marrow aspirate for treatment of musculoskeletal disease."

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