What research stage is stem-cell therapy for Diabetes (Type 1 & 2) at?
5 of 65 registered records carry a Phase 3 or Phase 4 label. The rest sit at earlier phases or carry no phase label at all. Snapshot 2026-08-29.
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 36 | 41% |
| Phase 2 | 35 | 40% |
| Not applicable | 11 | 12% |
| Phase 3 | 5 | 6% |
| Early Phase 1 | 1 | 1% |
What the phase mix means for Diabetes (Type 1 & 2)
The phase profile is bimodal: mature immune-modulation work alongside genuinely first-in-human islet-replacement programmes. Reading a single aggregate number for 'diabetes' obscures that split, so check which strategy a cited study belongs to.
The later-phase studies themselves
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT03562208 — Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients | Phase 2, Phase 3 | Unknown | 100 | Global Cell Med | 2018-01-01 |
| NCT01157403 — Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes | Phase 2, Phase 3 | Unknown | 80 | Lu Debin | 2010-07 |
| NCT04011020 — Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes | Phase 2, Phase 3 | Unknown | 50 | Throne Biotechnologies Inc. | 2022-09-20 |
| NCT06951074 — Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes | Phase 2, Phase 3 | Recruiting | 20 | Ain Shams University | 2025-04-01 |
| NCT02138331 — Effect of Microvesicles and Exosomes Therapy on β-cell Mass in Type I Diabetes Mellitus (T1DM) | Phase 2, Phase 3 | Unknown | 20 | General Committee of Teaching Hospitals and Institutes, Egyp | 2014-04 |
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 23 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 |
|---|---|---|---|---|---|
| NCT06065852 — National Registry of Rare Kidney Diseases | n/a | Recruiting | 35,000 | UK Kidney Association | 2009-11-06 |
| NCT04270604 — Biological Sample Collection for Research and Biobanking | n/a | Terminated | 1,279 | New York Stem Cell Foundation Research Institute | 2012-02-06 |
| NCT05253521 — The Role of South Asian vs European Origins on Circulating Regenerative Cell Exhaustion | n/a | Completed | 120 | Canadian Medical and Surgical Knowledge Translation Research | 2022-01-08 |
| NCT01350219 — Stem Cell Educator Therapy in Type 1 Diabetes | Phase 2 | Unknown | 100 | Throne Biotechnologies Inc. | 2010-09 |
| NCT03562208 — Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients | Phase 2, Phase 3 | Unknown | 100 | Global Cell Med | 2018-01-01 |
Frequently asked
What research stage is stem-cell therapy for Diabetes (Type 1 & 2) at?
5 of 65 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
- Diabetes (Type 1 & 2): cell-therapy evidence and registered trials
- How much does stem cell therapy for Diabetes (Type 1 & 2) cost? (2026)
- Diabetes (Type 1 & 2) stem cell therapy — your questions answered (2026)
- Diabetes (Type 1 & 2): cell-therapy evidence by therapy class
- MSC vs HSCT for Diabetes (Type 1 & 2): what the registries show