No cell therapy product for POI has FDA approval. Several investigational approaches are in clinical trials in the United States and abroad, but no regulatory approval pathway has been completed.
Premature ovarian insufficiency (POI)—formerly called premature ovarian failure—is cessation of ovarian hormone production and egg release before age 40, affecting approximately 1 in 100 women. Causes include genetic mutations (e.g., FMR1), autoimmune attack on follicles, chemotherapy or radiation damage, infection, or idiopathic (unknown) depletion of the primordial follicle pool. The result is infertility, oestrogen deficiency, and systemic menopausal symptoms despite young age. Current treatment is hormone replacement; fertility restoration is limited. Placental MSCs and fetal stem cells are being explored to regenerate follicle development or restore ovarian hormone production through direct cellular replacement, growth-factor secretion, and immunomodulation (suppressing anti-ovarian autoimmunity). Transplantation of cells into the ovary or systemic infusion aims to stimulate dormant follicles or create a regenerative microenvironment.
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Medically reviewed by StemCellAtlas’s editorial team with Dr Dmytro Stoyanov (Urologist · 31+ yrs clinical practice) of partner clinic Stem Plus (Sofia), against ISSCR, FDA & EMA guidance. Educational information, not medical advice; figures indicative.
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