How strong is the evidence for stem-cell therapy in Diabetes (Type 1 & 2)?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: the registry holds 65 records, 23 completed, 5 at Phase 3 or 4, and 10 stopped early (15%). MSC-specific work accounts for 29 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 Diabetes (Type 1 & 2)
Meaningful endpoints are insulin independence, C-peptide preservation and time-in-range on continuous monitoring, over a year or more. HbA1c improvement after an expensive trip usually reflects the diet, sleep and monitoring discipline that surrounds it.
What we can say from registrations alone
- Volume: 65 registered studies since 2003.
- Maturity: 5 confirmatory-phase records.
- Delivery: 23 completed; 10 terminated, withdrawn or suspended.
- Scale: median planned enrolment 23 participants, largest 35,000.
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 |
|---|---|---|---|---|---|
| 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 |
| NCT02644759 — Transplantation of Autologous Stem Cells for the Treatment of Type 1 Diabetes Mellitus | Phase 1, Phase 2 | Completed | 100 | Stem Cells Arabia | 2014-02 |
| NCT00690066 — PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM) | Phase 2 | Completed | 63 | Mesoblast, Inc. | 2008-06-11 |
| NCT01341899 — Efficacy and Safety Study of Autologous Hematopoietic Stem Cell Transplantation to Treat New Onset Type 1 Diabetes | Phase 2 | Completed | 50 | The Affiliated Nanjing Drum Tower Hospital of Nanjing Univer | 2006-06 |
| NCT00807651 — Autologous Hematopoietic Stem Cell Transplantation for Early Onset Type 1 Diabetes | Phase 2 | Completed | 40 | Shanghai Jiao Tong University School of Medicine | 2008-02 |
| NCT05207995 — The Treatment of Patients With Type 1 Diabetes Mellitus With Autologous Tolerogenic Dendritic Cells | Phase 1, Phase 2 | Completed | 32 | Institute of Biophysics and Cell Engineering of National Aca | 2022-03-01 |
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 "Diabetes (Type 1 & 2) 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 Diabetes (Type 1 & 2)?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is relatively mature, with multiple Phase 3/4 registrations: 65 registered records, 5 at Phase 3/4 and 10 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
Check the regulator's own register for the exact product name. Marketing frequently blurs approval for one narrow indication into approval in general.
Why do clinics cite hundreds of studies?
Because counting registrations is easy and sounds authoritative. The number that matters is how many controlled studies reported a clinically meaningful outcome for the product being sold.
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