Is stem cell therapy for Chronic Wounds & Ulcers FDA-approved?
There are no FDA-approved exosome products, and participation in a registered clinical trial is not FDA approval or clearance. No wound product should be described as an approved cell or exosome therapy without a verifiable product-level FDA or EMA record for the exact indication. CE marking, when applicable, is also not interchangeable with FDA approval or EMA medicinal-product authorisation.
How stem cells are studied for Chronic Wounds & Ulcers
Chronic wounds—including diabetic foot ulcers, pressure injuries and vascular ulcers—may fail to close because of impaired perfusion, infection, pressure, metabolic disease and disrupted inflammatory and repair processes. Cells and extracellular vesicles are being studied for proposed effects on immune signalling, angiogenesis, fibroblasts and extracellular matrix in preclinical models. Those mechanisms have not established durable closure or limb salvage in people. Diagnosis and treatment of infection, ischaemia, pressure and the underlying disease remain essential. The registry table on this page lists relevant studies and their current recruitment status.
Am I a candidate? → · Chronic Wounds & Ulcers: full overview → · Chronic Wounds & Ulcers cost → · Cost →
Evidence checked against ISSCR, FDA and EMA guidance. See our editorial standards. This is information, not medical advice. Educational information, not medical advice; figures indicative.
Sources & further reading
More on this condition
- Chronic Wounds & Ulcers: cell-therapy evidence and registered trials
- How much does stem cell therapy for Chronic Wounds & Ulcers cost? (2026)
- Chronic Wounds & Ulcers stem cell therapy — your questions answered (2026)
- Chronic Wounds & Ulcers: cell-therapy evidence by therapy class
- MSC vs PRP for Chronic Wounds & Ulcers: what the registries show