ALS (Motor Neurone Disease) and Haematopoietic stem-cell transplantation (HSCT): what the trial registry contains
The ClinicalTrials.gov registry holds 11 records for HSCT in ALS (Motor Neurone Disease): 0 recruiting now, 0 labelled Phase 3 or 4, across 5 countries. Snapshot 2026-08-29.
Why this is studied in ALS (Motor Neurone Disease)
ALS destroys motor neurons in the cortex, brainstem and spinal cord, and progression is measured in months. Cell-therapy rationales are neuroprotective rather than restorative: the hope is that transplanted or secreted factors slow the loss of remaining neurons. Nothing in the registered record has shown restored motor function, and the condition's rapid, variable decline makes uncontrolled improvement claims especially unreliable.
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 (amyotrophic lateral sclerosis x hematopoietic stem cell transplantation) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 11 |
| Interventional studies in the sample | 11 |
| Recruiting right now | 0 |
| Completed | 3 |
| Terminated, withdrawn or suspended | 1 |
| Phase 3 or Phase 4 records | 0 |
| Countries with at least one site | 5 |
| Median planned enrolment | 18 participants |
| Largest single planned enrolment | 50 participants |
| First / most recent start year | 2009 — 2025 |
How mature is this evidence?
There is no confirmatory research programme here — 11 registrations, all early-phase or unlabelled, 0 of them active.
Of those, 3 are marked completed and 1 were terminated, withdrawn or suspended — a stop rate of 9%, worth weighing when a clinic quotes 'ongoing research' as reassurance.
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 8 | 73% |
| Phase 2 | 2 | 18% |
| Not applicable | 1 | 9% |
Median planned enrolment is 18 participants (largest single study: 50). 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
Research is not evenly spread: Iran carries about 33% of the country mentions among 5 countries with sites.
| Country | Studies with a site there |
|---|---|
| Iran | 3 |
| United States | 2 |
| China | 2 |
| Poland | 1 |
| Italy | 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 3 commercial — a academic profile. Commercial sponsorship is not a red flag by itself, but it changes publication incentives.
- Royan Institute — 3 records
- University of Warmia and Mazury — 2 records
- Neuralstem Inc. — 2 records
- General Hospital of Chinese Armed Police Forces — 1 record
- Pomeranian Medical University Szczecin — 1 record
- Azienda Ospedaliera Santa Maria, Terni, Italy — 1 record
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 |
|---|---|---|---|---|---|
| NCT01730716 — Dose Escalation and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis | Phase 2 | Unknown | 18 | Neuralstem Inc. | 2013-05 |
| NCT01494480 — The Clinical Trial on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis | Phase 2 | Unknown | 30 | General Hospital of Chinese Armed Police Forces | 2012-03 |
| NCT02881489 — Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Patients With Amyotrophic Lateral Sclerosis | Phase 1 | Unknown | 30 | University of Warmia and Mazury | 2015-11 |
| NCT02881476 — Therapeutic Treatment of Amyotrophic Lateral Sclerosis | Phase 1 | Unknown | 30 | University of Warmia and Mazury | 2015-11 |
| NCT01759784 — Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS | Phase 1 | Withdrawn | n/a | Royan Institute | 2014-03 |
| NCT01771640 — Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS | Phase 1 | Completed | 8 | Royan Institute | 2013-08 |
| NCT01759797 — Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS | Phase 1 | Completed | 6 | Royan Institute | 2013-01 |
| NCT01640067 — Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS) | Phase 1 | Completed | 18 | Azienda Ospedaliera Santa Maria, Terni, Italy | 2011-12 |
| NCT02193893 — Biological Treatment of Amyotrophic Lateral Sclerosis | Phase 1 | Unknown | 50 | Pomeranian Medical University Szczecin | 2010-01 |
| NCT01348451 — Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis | Phase 1 | Unknown | 18 | Neuralstem Inc. | 2009-01 |
What this page does and does not tell you
None of these numbers say the therapy works. They say how much organised research exists and how far along it is; effect sizes live in published results, not registry entries.
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 ALS (Motor Neurone Disease) are recruiting right now?
0 of 11 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 ALS (Motor Neurone Disease)?
Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 11 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on HSCT for ALS (Motor Neurone Disease)?
0 of 11 records carry a Phase 3 or Phase 4 label and 3 are marked completed. Registrations run from 2009 to 2025.
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
- 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
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.