What research stage is stem-cell therapy for Alzheimer's Disease at?
Of 41 registrations, 0 reached a confirmatory phase label; everything else is earlier-stage or unlabelled (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 21 | 39% |
| Phase 2 | 21 | 39% |
| Not applicable | 10 | 19% |
| Early Phase 1 | 2 | 4% |
What the phase mix means for Alzheimer's Disease
Most registered cell work in Alzheimer's sits at Phase 1 and 2 — safety, dose and biomarker movement. Confirmatory designs are scarce because the field has learned how easily biomarker changes fail to translate into cognitive benefit, a lesson written into the history of anti-amyloid drug development.
The later-phase studies themselves
No registered study for this condition carries a Phase 3 or Phase 4 label in this snapshot. That is the single most useful fact on this page: the confirmatory stage has not been reached.
How to read phase labels
Phase 1 asks whether a dose is tolerated, usually in a small group without a control arm. Phase 2 looks for a signal and refines dosing. Phase 3 is confirmatory: larger, controlled, powered to test whether the intervention changes an outcome that matters. Not applicable appears for observational studies or where the sponsor assigned no phase, which is common in cell therapy and not a quality mark either way.
Median planned enrolment across sampled studies here is 33 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 |
|---|---|---|---|---|---|
| NCT04684602 — Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions | Phase 1, Phase 2 | Recruiting | 5,000 | Thomas Advanced Medical LLC | 2020-07-09 |
| 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 |
| 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 |
Frequently asked
What research stage is stem-cell therapy for Alzheimer's Disease at?
0 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.
More on this condition
- Alzheimer's Disease: cell-therapy evidence and registered trials
- How much does stem cell therapy for Alzheimer's Disease cost? (2026)
- Alzheimer's Disease stem cell therapy — your questions answered (2026)
- Alzheimer's Disease: cell-therapy evidence by therapy class
- MSC vs exosomes for Alzheimer's Disease: what the registries show