Registry evidence

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.

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 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.

MetricValue
Registered studies (all statuses)11
Interventional studies in the sample11
Recruiting right now0
Completed3
Terminated, withdrawn or suspended1
Phase 3 or Phase 4 records0
Countries with at least one site5
Median planned enrolment18 participants
Largest single planned enrolment50 participants
First / most recent start year2009 — 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Of those, 3 are marked completed and 1 were terminated, withdrawn or suspended — a stop rate of 9%, worth weighing when a clinic quotes 'ongoing research' as reassurance.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 labelRecordsShare
Phase 1873%
Phase 2218%
Not applicable19%

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.

CountryStudies with a site there
Iran3
United States2
China2
Poland1
Italy1

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.

StudyPhaseStatusPlanned nLead sponsorStart
NCT01730716 — Dose Escalation and Safety Study of Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral SclerosisPhase 2Unknown18Neuralstem Inc.2013-05
NCT01494480 — The Clinical Trial on the Use of Umbilical Cord Mesenchymal Stem Cells in Amyotrophic Lateral SclerosisPhase 2Unknown30General Hospital of Chinese Armed Police Forces2012-03
NCT02881489 — Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Patients With Amyotrophic Lateral SclerosisPhase 1Unknown30University of Warmia and Mazury2015-11
NCT02881476 — Therapeutic Treatment of Amyotrophic Lateral SclerosisPhase 1Unknown30University of Warmia and Mazury2015-11
NCT01759784 — Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALSPhase 1Withdrawnn/aRoyan Institute2014-03
NCT01771640 — Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALSPhase 1Completed8Royan Institute2013-08
NCT01759797 — Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALSPhase 1Completed6Royan Institute2013-01
NCT01640067 — Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS)Phase 1Completed18Azienda Ospedaliera Santa Maria, Terni, Italy2011-12
NCT02193893 — Biological Treatment of Amyotrophic Lateral SclerosisPhase 1Unknown50Pomeranian Medical University Szczecin2010-01
NCT01348451 — Human Spinal Cord Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral SclerosisPhase 1Unknown18Neuralstem 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.

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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.