Is stem cell therapy for ALS (Motor Neurone Disease) FDA-approved?
No regenerative medicine therapy is FDA-approved for ALS. An IND-authorised trial, expanded-access request or registry listing is not product approval and does not establish efficacy. In Europe, trial or compassionate-use pathways are 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 ALS (Motor Neurone Disease)
Amyotrophic lateral sclerosis (ALS or motor neurone disease) is a neurodegenerative condition characterised by progressive loss of motor neurons in the spinal cord, brainstem and motor cortex. Multiple mechanisms are under investigation, including excitotoxicity, mitochondrial dysfunction, protein misfolding and neuroinflammation. Neural progenitor and mesenchymal stromal cell approaches are being studied for proposed neuroprotective or supportive effects, but these mechanisms have not established slowed progression or restored motor function in people. The registry table on this page lists relevant studies and their current recruitment status.
Am I a candidate? → · ALS (Motor Neurone Disease): full overview → · ALS (Motor Neurone Disease) 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
- ALS (Motor Neurone Disease): cell-therapy evidence and registered trials
- How much does stem cell therapy for ALS (Motor Neurone Disease) cost? (2026)
- ALS (Motor Neurone Disease) stem cell therapy — your questions answered (2026)
- ALS (Motor Neurone Disease): cell-therapy evidence by therapy class
- MSC vs HSCT for ALS (Motor Neurone Disease): what the registries show