What research stage is stem-cell therapy for Cerebral Palsy at?
Confirmatory-phase work accounts for 2 of the 41 records here; the remainder is dose-finding, safety or observational (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 21 | 40% |
| Phase 1 | 17 | 33% |
| Not applicable | 11 | 21% |
| Phase 3 | 2 | 4% |
| Early Phase 1 | 1 | 2% |
What the phase mix means for Cerebral Palsy
The registered base is mostly early-phase with small cohorts. Where later-phase work exists it typically pairs cells with an intensive rehabilitation protocol, which makes attribution harder rather than easier unless the control arm receives the same rehabilitation.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT01929434 — Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Patients With Cerebral Paralysis | Phase 3 | Completed | 300 | General Hospital of Chinese Armed Police Forces | 2013-10 |
| NCT01832454 — Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years | Phase 2, Phase 3 | Unknown | 100 | Chaitanya Hospital, Pune | 2011-03 |
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 40 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 |
|---|---|---|---|---|---|
| NCT02795052 — Neurologic Stem Cell Treatment Study | n/a | Recruiting | 500 | MD Stem Cells | 2016-06 |
| NCT01929434 — Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Patients With Cerebral Paralysis | Phase 3 | Completed | 300 | General Hospital of Chinese Armed Police Forces | 2013-10 |
| NCT04098029 — Estimation of the Safety and Efficiency Transfusion of HLA Matched CBU in Patients With CP | Phase 2 | Unknown | 150 | State-Financed Health Facility "Samara Regional Medical Cent | 2019-09-01 |
| NCT03795974 — Efficacy of Allogeneic Umbilical Cord Derived Hematopoietic and Mesenchymal Stem Cells in Cerebral Palsy | Phase 2 | Unknown | 108 | Tehran University of Medical Sciences | 2017-07-23 |
| NCT01193660 — Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy | n/a | Completed | 105 | Sung Kwang Medical Foundation | 2010-05 |
Frequently asked
What research stage is stem-cell therapy for Cerebral Palsy at?
2 of 41 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.