How strong is the evidence for stem-cell therapy in Alzheimer's Disease?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is active but still early, with limited late-phase registration: the registry holds 41 records, 8 completed, 0 at Phase 3 or 4, and 4 stopped early (10%). MSC-specific work accounts for 23 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 Alzheimer's Disease
A meaningful result changes a validated cognitive and functional measure over at least twelve months against a control arm, not a biomarker in isolation. Caregiver-reported alertness in the weeks after an expensive intervention is the least reliable signal in the whole field and the one most often used in testimonials.
What we can say from registrations alone
- Volume: 41 registered studies since 2009.
- Maturity: 0 confirmatory-phase records.
- Delivery: 8 completed; 4 terminated, withdrawn or suspended.
- Scale: median planned enrolment 33 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 |
|---|---|---|---|---|---|
| NCT04052737 — PMZ-1620 (Sovateltide) in Mild to Moderate Alzheimer's Disease | Phase 2 | Completed | 80 | Pharmazz, Inc. | 2018-03-23 |
| NCT02054208 — Safety and Exploratory Efficacy Study of NEUROSTEM® Versus Placebo in Patients With Alzheimer's Disease | Phase 1, Phase 2 | Completed | 46 | Medipost Co Ltd. | 2014-03 |
| NCT03172117 — Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial. | Phase 1, Phase 2 | Completed | 36 | Medipost Co Ltd. | 2017-05-19 |
| NCT01083316 — Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis | Phase 2 | Completed | 35 | Boston Medical Center | 2009-09 |
| NCT02600130 — Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's Disease | Phase 1 | Completed | 33 | Longeveron Inc. | 2016-10-10 |
| NCT03117738 — A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease | Phase 1, Phase 2 | Completed | 21 | Nature Cell Co. Ltd. | 2017-05-09 |
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 "Alzheimer's Disease 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 Alzheimer's Disease?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is active but still early, with limited late-phase registration: 41 registered records, 0 at Phase 3/4 and 4 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
Approval is product-and-indication specific and changes over time; check the FDA, EMA or your national regulator directly rather than relying on a clinic's summary.
Why do clinics cite hundreds of studies?
Because the registry is public and impressive-looking. What it cannot show — published, controlled outcomes for the exact product — is the part that decides the question.
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