Is stem cell therapy for Heart Failure & Cardiac Repair FDA-approved?
No regenerative medicine therapy is FDA-approved for heart failure or other cardiovascular disease. An IND-authorised trial, registry listing or expanded-access pathway is not product approval. In Europe, a national trial authorisation is distinct from EMA marketing authorisation. Patients should verify the exact product, sponsor, registry identifier, competent authority and ethics approval.
How stem cells are studied for Heart Failure & Cardiac Repair
Heart failure is a clinical syndrome in which impaired cardiac contraction, relaxation or both causes symptoms and circulatory dysfunction. Causes include myocardial infarction, hypertension, cardiomyopathy and valvular disease. Mesenchymal stromal cells (MSCs) and extracellular vesicles are being studied for possible effects on inflammation, fibrosis, angiogenesis and cell survival observed mainly in preclinical models. Those mechanisms have not established clinically meaningful cardiac repair in people. The registry table on this page lists relevant studies and their current recruitment status.
Am I a candidate? → · Heart Failure & Cardiac Repair: full overview → · Heart Failure & Cardiac Repair 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
- Heart Failure & Cardiac Repair: cell-therapy evidence and registered trials
- How much does stem cell therapy for Heart Failure & Cardiac Repair cost? (2026)
- Heart Failure & Cardiac Repair stem cell therapy — your questions answered (2026)
- Heart Failure & Cardiac Repair: cell-therapy evidence by therapy class
- MSC vs HSCT for Heart Failure & Cardiac Repair: what the registries show