Is stem cell therapy for Premature Ovarian Insufficiency FDA-approved?
No regenerative medicine therapy is FDA-approved for POI or fertility restoration. An IND-authorised trial or registry listing is not product approval. In Europe, a 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 Premature Ovarian Insufficiency
Premature ovarian insufficiency (POI) is loss of ovarian function before age 40, confirmed through menstrual history and biochemical assessment. It can affect fertility, bone, cardiovascular, sexual and psychological health. Causes and residual ovarian activity vary. Mesenchymal stromal cells (MSCs) and other biological approaches are being studied, but proposed follicle, hormonal or immune mechanisms have not established restored fertility or live birth. Cell injection or infusion is not standard POI care. The registry table on this page lists relevant studies and their current recruitment status.
Am I a candidate? → · Premature Ovarian Insufficiency: full overview → · Premature Ovarian Insufficiency 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
- Premature Ovarian Insufficiency: cell-therapy evidence and registered trials
- How much does stem cell therapy for Premature Ovarian Insufficiency cost? (2026)
- Premature Ovarian Insufficiency stem cell therapy — your questions answered (2026)
- Premature Ovarian Insufficiency: cell-therapy evidence by therapy class
- MSC vs PRP for Premature Ovarian Insufficiency: what the registries show