What research stage is stem-cell therapy for Multiple Sclerosis at?
The ladder for this condition: 3 Phase 3 or 4 records out of 92 registrations in total, snapshot 2026-08-29.
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 47 | 39% |
| Phase 2 | 46 | 38% |
| Not applicable | 22 | 18% |
| Phase 3 | 3 | 2% |
| Early Phase 1 | 2 | 2% |
What the phase mix means for Multiple Sclerosis
Phase distribution mixes mature transplantation trials with early mesenchymal work. Aggregate counts flatter the newer approach by borrowing the maturity of the older one.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT04047628 — Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS) | Phase 3 | Recruiting | 156 | National Institute of Allergy and Infectious Diseases (NIAID | 2019-12-19 |
| NCT03477500 — Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for RRMS (RAM-MS) | Phase 3 | Active Not Recruiting | 100 | Haukeland University Hospital | 2018-03-21 |
| NCT03342638 — Maximizing Outcome of Multiple Sclerosis Transplantation | Phase 3 | Terminated | 66 | Northwestern University | 2017-11-08 |
How to read phase labels
Early phases exist to find harm and set a dose. They are not built to detect benefit, and they routinely produce encouraging-looking numbers that later trials fail to reproduce. Only a confirmatory design with a comparison arm can separate the intervention from everything else happening to a patient.
Median planned enrolment across sampled studies here is 24 participants. Small single-arm studies can flag safety problems; they cannot separate a treatment effect from natural fluctuation, placebo response or regression to the mean.
The largest studies by planned enrolment
Size is a crude proxy for what a study can detect, but it separates a serious attempt from a case series presented as evidence.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT06065852 — National Registry of Rare Kidney Diseases | n/a | Recruiting | 35,000 | UK Kidney Association | 2009-11-06 |
| NCT01953523 — Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions | n/a | Completed | 3,000 | Elliot Lander | 2013-09-02 |
| NCT02674217 — Outpatient Hematopoietic Grafting in Multiple Sclerosis Employing Autologous Peripheral Blood Stem Cells | n/a | Unknown | 1,000 | Centro de Hematología y Medicina Interna | 2015-05 |
| NCT02795052 — Neurologic Stem Cell Treatment Study | n/a | Recruiting | 500 | MD Stem Cells | 2016-06 |
| NCT02157064 — Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis | n/a | Unknown | 221 | StemGenex | 2014-05 |
Frequently asked
What research stage is stem-cell therapy for Multiple Sclerosis at?
3 of 92 records are labelled Phase 3 or 4 (2026-08-29).
Is a Phase 3 trial proof that it works?
No — it is a design capable of testing that question. Proof depends on the reported result, replication, and whether the outcome measured matters to patients.
Why do so many records have no phase?
Observational studies and some cell-therapy protocols are registered without a phase label. It is a registry field, not a quality rating.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.
More on this condition
- Multiple Sclerosis: cell-therapy evidence and registered trials
- How much does stem cell therapy for Multiple Sclerosis cost? (2026)
- Multiple Sclerosis stem cell therapy — your questions answered (2026)
- Multiple Sclerosis: cell-therapy evidence by therapy class
- MSC vs HSCT for Multiple Sclerosis: what the registries show