What research stage is stem-cell therapy for Parkinson's Disease at?
Of 71 registrations, 3 reached a confirmatory phase label; everything else is earlier-stage or unlabelled (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 37 | 43% |
| Not applicable | 21 | 24% |
| Phase 2 | 21 | 24% |
| Early Phase 1 | 4 | 5% |
| Phase 3 | 3 | 3% |
What the phase mix means for Parkinson's Disease
The field is early in phase terms but methodologically advanced, with long-planned follow-up because grafts must be assessed over years. Small registered numbers reflect surgical complexity, not lack of seriousness.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT06944522 — A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease | Phase 3 | Recruiting | 102 | BlueRock Therapeutics | 2025-06-17 |
| NCT04146519 — Parkinson's Disease Therapy Using Cell Technology | Phase 2, Phase 3 | Unknown | 50 | Belarusian Medical Academy of Post-Graduate Education | 2017-07-01 |
| NCT03128450 — A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient | Phase 2, Phase 3 | Unknown | 12 | Second Affiliated Hospital of Soochow University | 2017-04-15 |
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 16 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 |
|---|---|---|---|---|---|
| NCT01953523 — Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions | n/a | Completed | 3,000 | Elliot Lander | 2013-09-02 |
| NCT04270604 — Biological Sample Collection for Research and Biobanking | n/a | Terminated | 1,279 | New York Stem Cell Foundation Research Institute | 2012-02-06 |
| NCT07214974 — Mild Cognitive Impairment Community Screening and Early Intervention Via Stem Cell Therapy and Wearable Brain Computer Interface Device. | Early Phase 1 | Not Yet Recruiting | 600 | Noah Tech, Corp. | 2026-09-01 |
| NCT02795052 — Neurologic Stem Cell Treatment Study | n/a | Recruiting | 500 | MD Stem Cells | 2016-06 |
| NCT03297177 — Autologous Stem/Stromal Cells in Neurological Disorders and Disease | n/a | Unknown | 300 | Regeneris Medical | 2020-01-01 |
Frequently asked
What research stage is stem-cell therapy for Parkinson's Disease at?
3 of 71 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
- Parkinson's Disease: cell-therapy evidence and registered trials
- How much does stem cell therapy for Parkinson's Disease cost? (2026)
- Parkinson's Disease stem cell therapy — your questions answered (2026)
- Parkinson's Disease: cell-therapy evidence by therapy class
- MSC vs exosomes for Parkinson's Disease: what the registries show