ALS (Motor Neurone Disease) and Mesenchymal stem/stromal cells (MSC): what the trial registry contains
The ClinicalTrials.gov registry holds 29 records for MSC in ALS (Motor Neurone Disease): 2 recruiting now, 3 labelled Phase 3 or 4, across 10 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 MSC means in this table
Mesenchymal stromal cells are the workhorse of commercial cell therapy: easy to source from fat, cord or marrow, easy to expand, and rarely characterised in the same way twice. Their proposed action is paracrine — signalling molecules that damp inflammation — rather than replacement of lost tissue. That matters when reading counts like these, because two studies filed under the same label can test materially different products at different doses by different routes.
The numbers
Every figure below comes from one reproducible query (amyotrophic lateral sclerosis x mesenchymal stem cell) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 29 |
| Interventional studies in the sample | 27 |
| Recruiting right now | 2 |
| Completed | 14 |
| Terminated, withdrawn or suspended | 4 |
| Phase 3 or Phase 4 records | 3 |
| Countries with at least one site | 10 |
| Median planned enrolment | 27 participants |
| Largest single planned enrolment | 200 participants |
| First / most recent start year | 2010 — 2025 |
How mature is this evidence?
Later-phase work exists but is not dominant (3 of 29), which is the typical profile of a field that has shown safety and is still testing whether benefit survives a control arm.
The delivery record matters as much as the count: 14 completed against 4 abandoned or suspended, or 14% of everything registered.
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 19 | 53% |
| Phase 2 | 11 | 31% |
| Phase 3 | 3 | 8% |
| Not applicable | 3 | 8% |
Median planned enrolment is 27 participants (largest single study: 200). 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 10, but the distribution has a long tail behind United States at about 31% of mentions.
| Country | Studies with a site there |
|---|---|
| United States | 8 |
| Iran | 5 |
| China | 3 |
| Brazil | 2 |
| South Korea | 2 |
| Israel | 2 |
| Antigua and Barbuda | 1 |
| Italy | 1 |
| Spain | 1 |
| Poland | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
The sponsor mix is commercial (8 academic or hospital, 10 commercial among the most frequent lead sponsors).
- Brainstorm-Cell Therapeutics — 6 records
- Royan Institute — 4 records
- University of Warmia and Mazury — 2 records
- Xuanwu Hospital, Beijing — 2 records
- Mayo Clinic — 2 records
- Corestemchemon, Inc. — 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 |
|---|---|---|---|---|---|
| NCT06598202 — Exploring Nasal Drop Therapy With Small Extracellular Vesicles for ALS | Phase 1, Phase 2 | Recruiting | 38 | Xuanwu Hospital, Beijing | 2024-12-01 |
| NCT06551649 — Human Amniotic Mesenchymal Cell Secretome for Neurodegeneration and Neuroinflammation | n/a | Recruiting | 60 | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 2025-01-17 |
| NCT06973629 — Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY) | Phase 3 | Not Yet Recruiting | 200 | Brainstorm-Cell Therapeutics | 2025-06-30 |
| NCT04745299 — Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALS | Phase 3 | Completed | 123 | Corestemchemon, Inc. | 2021-02-24 |
| NCT03280056 — Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients | Phase 3 | Completed | 196 | Brainstorm-Cell Therapeutics | 2017-08-28 |
| NCT06910384 — A Study of STRO4 in Patients Amyotrophic Lateral Sclerosis (ALS) | Phase 2 | Terminated | 1 | New England Cell Therapeutics, Inc. | 2025-08-12 |
| NCT04651855 — The Evaluation of the Effect of Mesenchymal Stem Cells on the Immune System of Patients With ALS | Phase 1, Phase 2 | Unknown | 20 | Polski Bank Komorek Macierzystych JSC (PBKM) | 2020-12-02 |
| NCT04821479 — Repeated Mesenchymal Stem Cell Injections in ALS | Phase 1, Phase 2 | Completed | 20 | Hadassah Medical Organization | 2016-01-01 |
| NCT02917681 — Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis | Phase 1, Phase 2 | Unknown | 28 | University of Sao Paulo General Hospital | 2016-09 |
| NCT02116634 — Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis | Phase 1, Phase 2 | Withdrawn | n/a | Alzahra Hospital, Iran | 2015-05 |
What this page does and does not tell you
These figures describe effort, not outcome. Published results, with their control arms and endpoints, are where benefit is decided.
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 MSC studies for ALS (Motor Neurone Disease) are recruiting right now?
2 of 29 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.
Is MSC 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. 29 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on MSC for ALS (Motor Neurone Disease)?
3 of 29 records carry a Phase 3 or Phase 4 label and 14 are marked completed. Registrations run from 2010 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.