What research stage is stem-cell therapy for Stroke Recovery at?
The ladder for this condition: 6 Phase 3 or 4 records out of 110 registrations in total, snapshot 2026-08-29.
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 65 | 45% |
| Phase 2 | 56 | 39% |
| Not applicable | 15 | 10% |
| Phase 3 | 5 | 3% |
| Early Phase 1 | 1 | 1% |
| Phase 4 | 1 | 1% |
What the phase mix means for Stroke Recovery
There is meaningful later-phase activity here, including trials that used blinded scoring in chronic stroke. Those designs exist precisely because the field learned how deceptive open-label recovery data can be.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT03545607 — MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study | Phase 3 | Terminated | 206 | Healios K.K. | 2018-07-28 |
| NCT05955326 — Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | Phase 4 | Recruiting | 160 | Pharmazz, Inc. | 2024-01-08 |
| NCT04047563 — Efficacy of Sovateltide (PMZ-1620) in Patients of Acute Ischemic Stroke | Phase 3 | Completed | 158 | Pharmazz, Inc. | 2019-11-10 |
| NCT06129175 — UCMSCs as Treatment for Patients With Acute Ischemic Stroke (Stroke Neuroncell-EX) | Phase 2, Phase 3 | Recruiting | 80 | Cytopeutics Sdn. Bhd. | 2023-12-19 |
| NCT01716481 — The STem Cell Application Researches and Trials In NeuroloGy-2 (STARTING-2) Study | Phase 3 | Unknown | 60 | Samsung Medical Center | 2012-11 |
| NCT02849613 — Regenerative Stem Cell Therapy for Stroke in Europe | Phase 2, Phase 3 | Withdrawn | n/a | University Hospital, Grenoble | 2016-03 |
How to read phase labels
Early phases exist to find harm and set a dose. They are not built to detect benefit, and they routinely produce encouraging-looking numbers that later trials fail to reproduce. Only a confirmatory design with a comparison arm can separate the intervention from everything else happening to a patient.
Median planned enrolment across sampled studies here is 30 participants. Small single-arm studies can flag safety problems; they cannot separate a treatment effect from natural fluctuation, placebo response or regression to the mean.
The largest studies by planned enrolment
Size is a crude proxy for what a study can detect, but it separates a serious attempt from a case series presented as evidence.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT03899298 — Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions | Phase 1 | Not Yet Recruiting | 5,000 | R3 Stem Cell | 2019-09-01 |
| NCT02795052 — Neurologic Stem Cell Treatment Study | n/a | Recruiting | 500 | MD Stem Cells | 2016-06 |
| NCT03545607 — MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study | Phase 3 | Terminated | 206 | Healios K.K. | 2018-07-28 |
| NCT02980354 — Bayraktutan Dunhill Medical Trust EPC Study | n/a | Unknown | 200 | University of Nottingham | 2017-02-01 |
| NCT02448641 — Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke | Phase 2 | Completed | 163 | SanBio, Inc. | 2016-03-08 |
Frequently asked
What research stage is stem-cell therapy for Stroke Recovery at?
6 of 110 records are labelled Phase 3 or 4 (2026-08-29).
Is a Phase 3 trial proof that it works?
No — it is a design capable of testing that question. Proof depends on the reported result, replication, and whether the outcome measured matters to patients.
Why do so many records have no phase?
Observational studies and some cell-therapy protocols are registered without a phase label. It is a registry field, not a quality rating.
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
- Stroke Recovery: cell-therapy evidence and registered trials
- How much does stem cell therapy for Stroke Recovery cost? (2026)
- Stroke Recovery stem cell therapy — your questions answered (2026)
- Stroke Recovery: cell-therapy evidence by therapy class
- MSC vs HSCT for Stroke Recovery: what the registries show