Multiple Sclerosis and Haematopoietic stem-cell transplantation (HSCT): what the trial registry contains
The ClinicalTrials.gov registry holds 38 records for HSCT in Multiple Sclerosis: 6 recruiting now, 3 labelled Phase 3 or 4, across 15 countries. Snapshot 2026-08-29.
Why this is studied in Multiple Sclerosis
MS is immune-mediated demyelination with axonal loss. It holds an unusual position in this field: autologous haematopoietic transplantation has controlled evidence in aggressive relapsing disease and is offered in national health systems in several countries, while mesenchymal infusions marketed to MS patients have a much weaker base. The gap between those two is the single most important distinction in this indication.
What HSCT means in this table
Haematopoietic transplantation is the oldest and most consequential cell therapy in medicine, with conditioning regimens that carry real mortality risk alongside genuine disease-modifying power. Registrations under this label therefore mix decades-old standard-of-care protocols with newer autoimmune-reset trials, and the risk profile is nothing like that of an outpatient infusion.
The numbers
Every figure below comes from one reproducible query (multiple sclerosis x hematopoietic stem cell transplantation) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 38 |
| Interventional studies in the sample | 29 |
| Recruiting right now | 6 |
| Completed | 13 |
| Terminated, withdrawn or suspended | 9 |
| Phase 3 or Phase 4 records | 3 |
| Countries with at least one site | 15 |
| Median planned enrolment | 24 participants |
| Largest single planned enrolment | 1,000 participants |
| First / most recent start year | 1997 — 2026 |
How mature is this evidence?
Later-phase work exists but is not dominant (3 of 38), which is the typical profile of a field that has shown safety and is still testing whether benefit survives a control arm.
13 records are marked completed and 9 ended early (terminated, withdrawn or suspended): 24% of registrations did not run to plan.
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 14 | 33% |
| Phase 1 | 13 | 31% |
| Not applicable | 12 | 29% |
| Phase 3 | 3 | 7% |
Median planned enrolment is 24 participants (largest single study: 1,000). Trials of this size can describe safety and generate hypotheses; detecting a modest clinical benefit reliably usually needs substantially larger numbers with a control group.
Where the studies are
Country coverage runs to 15, but the distribution has a long tail behind United States at about 50% of mentions.
| Country | Studies with a site there |
|---|---|
| United States | 15 |
| Italy | 3 |
| Sweden | 3 |
| Russia | 2 |
| Netherlands | 2 |
| Philippines | 1 |
| Germany | 1 |
| United Kingdom | 1 |
| Denmark | 1 |
| Norway | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
Lead sponsors split roughly 7 academic or hospital against 8 commercial — a commercial profile. Commercial sponsorship is not a red flag by itself, but it changes publication incentives.
- Fred Hutchinson Cancer Center — 3 records
- Talaris Therapeutics Inc. — 3 records
- Northwestern University — 3 records
- St. Petersburg State Pavlov Medical University — 2 records
- IRCCS San Raffaele — 2 records
- National Institute of Allergy and Infectious Diseases (NIAID) — 2 records
Representative registered studies
Recruiting studies first, then the most advanced phases. Each identifier links to the registry record, where eligibility criteria, outcome measures and contacts are published.
| 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 |
| NCT05832515 — AHSCT With Fludarabine and Cyclophosphamide Based Conditioning Regimes in Patients With Multiple Sclerosis | Phase 1 | Recruiting | 200 | St. Petersburg State Pavlov Medical University | 2020-10-01 |
| NCT07635693 — ATLG Levels in Autologous HSCT for Multiple Sclerosis | n/a | Recruiting | 20 | Ciceri Fabio | 2026-05-04 |
| NCT06567197 — Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands | n/a | Recruiting | 24 | Amsterdam UMC, location VUmc | 2023-08-25 |
| NCT06218927 — The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related to QoL in MS Patients | n/a | Recruiting | 40 | University Hospital Ostrava | 2023-11-01 |
| NCT06267781 — RRMS: Disease PROgression and Myeloid Profiling After Bone Marrow TRANSPLANTation and Second Line Therapies | n/a | Recruiting | 30 | IRCCS San Raffaele | 2022-09-02 |
| 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 |
| NCT00716066 — Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases | Phase 2 | Active Not Recruiting | 53 | Fred Hutchinson Cancer Center | 2008-06 |
| NCT03342638 — Maximizing Outcome of Multiple Sclerosis Transplantation | Phase 3 | Terminated | 66 | Northwestern University | 2017-11-08 |
| NCT04971005 — Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Tr | Phase 2 | Terminated | 1 | Universitätsklinikum Hamburg-Eppendorf | 2021-08-27 |
What this page does and does not tell you
Registration counts measure activity, not effect. A study appears here the moment it is registered — before any participant is enrolled, and regardless of whether results are ever posted.
If a clinic offers you this today, the useful question is not "is there research?" but "which of these registered studies is mine part of, and if none, what evidence applies to the exact product I am being sold?" The Provider Question Builder turns that into a scored checklist.
Frequently asked
How many HSCT studies for Multiple Sclerosis are recruiting right now?
6 of 38 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.
Is HSCT an approved treatment for Multiple Sclerosis?
Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 38 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on HSCT for Multiple Sclerosis?
3 of 38 records carry a Phase 3 or Phase 4 label and 13 are marked completed. Registrations run from 1997 to 2026.
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
Download the query data
Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.