Is stem cell therapy for Fibromyalgia & Chronic Fatigue FDA-approved?
No regenerative medicine therapy is FDA-approved for fibromyalgia or chronic pain. 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 Fibromyalgia & Chronic Fatigue
Fibromyalgia is a chronic condition characterised by widespread pain, fatigue, sleep disturbance and often cognitive symptoms. Its biology is complex and cannot be reduced to a single neurotransmitter or inflammatory pathway. Mesenchymal stromal cells (MSCs) and extracellular vesicles are being explored for proposed immunomodulatory or neuromodulatory effects, but these mechanisms have not established clinical benefit. Cell or exosome infusion is not standard fibromyalgia care. The registry table on this page lists relevant studies and their current recruitment status.
Am I a candidate? → · Fibromyalgia & Chronic Fatigue: full overview → · Fibromyalgia & Chronic Fatigue 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.