Registry evidence

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.

Medical review statusMedically reviewedReviewed by: Stem Plus medical teamReviewed on: 2026-08-29Last evidence update: 2026-08-29Methodology and editorial standards
Clinical review team: Dr Kamelia Milcheva, Hematologist · Dr Vadym Uvarov, Board-Certified Physician · Hepatobiliary Surgeon · Candidate of Medical SciencesEditorial responsibility: StemCellAtlas research teamEducational information only. This page does not provide medical advice, diagnosis or a treatment recommendation.

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.

MetricValue
Registered studies (all statuses)38
Interventional studies in the sample29
Recruiting right now6
Completed13
Terminated, withdrawn or suspended9
Phase 3 or Phase 4 records3
Countries with at least one site15
Median planned enrolment24 participants
Largest single planned enrolment1,000 participants
First / most recent start year1997 — 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13 records are marked completed and 9 ended early (terminated, withdrawn or suspended): 24% of registrations did not run to plan.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 labelRecordsShare
Phase 21433%
Phase 11331%
Not applicable1229%
Phase 337%

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.

CountryStudies with a site there
United States15
Italy3
Sweden3
Russia2
Netherlands2
Philippines1
Germany1
United Kingdom1
Denmark1
Norway1

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.

StudyPhaseStatusPlanned nLead sponsorStart
NCT04047628 — Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)Phase 3Recruiting156National Institute of Allergy and Infectious Diseases (NIAID2019-12-19
NCT05832515 — AHSCT With Fludarabine and Cyclophosphamide Based Conditioning Regimes in Patients With Multiple SclerosisPhase 1Recruiting200St. Petersburg State Pavlov Medical University2020-10-01
NCT07635693 — ATLG Levels in Autologous HSCT for Multiple Sclerosisn/aRecruiting20Ciceri Fabio2026-05-04
NCT06567197 — Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlandsn/aRecruiting24Amsterdam UMC, location VUmc2023-08-25
NCT06218927 — The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related to QoL in MS Patientsn/aRecruiting40University Hospital Ostrava2023-11-01
NCT06267781 — RRMS: Disease PROgression and Myeloid Profiling After Bone Marrow TRANSPLANTation and Second Line Therapiesn/aRecruiting30IRCCS San Raffaele2022-09-02
NCT03477500 — Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for RRMS (RAM-MS)Phase 3Active Not Recruiting100Haukeland University Hospital2018-03-21
NCT00716066 — Autologous Stem Cell Transplant for Neurologic Autoimmune DiseasesPhase 2Active Not Recruiting53Fred Hutchinson Cancer Center2008-06
NCT03342638 — Maximizing Outcome of Multiple Sclerosis TransplantationPhase 3Terminated66Northwestern University2017-11-08
NCT04971005 — Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled TrPhase 2Terminated1Universitätsklinikum Hamburg-Eppendorf2021-08-27

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.

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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.