How strong is the evidence for stem-cell therapy in Stroke Recovery?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: the registry holds 110 records, 40 completed, 6 at Phase 3 or 4, and 14 stopped early (13%). MSC-specific work accounts for 45 of those records. These counts describe research activity and maturity, not benefit, safety or certainty. Snapshot 2026-08-29.
What counts as a real result in Stroke Recovery
Endpoints are modified Rankin score, Fugl-Meyer and NIH Stroke Scale assessed blind against a control receiving equivalent rehabilitation. Improvement during a treatment package that includes daily physiotherapy is attributable to the physiotherapy until a controlled comparison says otherwise.
What we can say from registrations alone
- Volume: 110 registered studies since 2005.
- Maturity: 6 confirmatory-phase records.
- Delivery: 40 completed; 14 terminated, withdrawn or suspended.
- Scale: median planned enrolment 30 participants, largest 5,000.
The completed studies
Completed does not mean published, and published does not mean positive. These are the finished records — the starting point for checking whether results ever appeared.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| 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 |
| NCT04047563 — Efficacy of Sovateltide (PMZ-1620) in Patients of Acute Ischemic Stroke | Phase 3 | Completed | 158 | Pharmazz, Inc. | 2019-11-10 |
| NCT04811651 — Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke | Phase 2 | Completed | 156 | General Hospital of Shenyang Military Region | 2021-03-15 |
| NCT01436487 — Study to Examine the Effects of MultiStem in Ischemic Stroke | Phase 2 | Completed | 134 | Healios K.K. | 2011-10 |
| NCT02425670 — Stem Cell Therapy For Acute Ischemic Stroke Patients | Phase 2 | Completed | 120 | All India Institute of Medical Sciences | 2009-01 |
| NCT01501773 — Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke | Phase 2 | Completed | 120 | Manipal Acunova Ltd. | 2008-10 |
What registrations cannot tell you
Whether results were positive. Whether they were published at all — a large share of registered studies never report outcomes, which biases what the literature appears to show. And whether the product a commercial clinic sells resembles the product studied: cell source, dose, processing and delivery route vary enormously between a registered protocol and an off-protocol injection.
How to use this when someone is selling you a treatment
Ask which specific registered study supports the offer, then compare its intervention description with your quote. If the answer is a general gesture at "Stroke Recovery research", you are being sold the field's activity rather than evidence about the product. The Provider Question Builder turns that gap into questions.
Frequently asked
How strong is the evidence for stem-cell therapy in Stroke Recovery?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: 110 registered records, 6 at Phase 3/4 and 14 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
That has to be checked per product with the regulator that governs where you would be treated. A clinic's own claim of approval is not verification.
Why do clinics cite hundreds of studies?
Because counting registrations is easy and sounds authoritative. The number that matters is how many controlled studies reported a clinically meaningful outcome for the product being sold.
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