Single-center phase 3 islet transplantation in non-uremic T1D
What this study tests
Northwestern phase 3 donor-islet transplant study for non-uremic people with difficult T1D control. Now completed, with results posted in June 2026 — but of 10 people enrolled, only 2 were actually transplanted, so it is a very small transplant experience rather than a 10-patient efficacy readout.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-06-18.
Most recent recorded citation date: 2026-06-18. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- See registry for full inclusion/exclusion criteria. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- Completed February 2025 (primary completion July 2021); results were first posted on ClinicalTrials.gov in June 2026. The headline number is small: 105 people were screened and 10 enrolled, but only 2 actually received islets — the other 8 withdrew before any transplant. The posted primary outcome (participants free of severe hypoglycaemic events two years after their final islet infusion) was met by 2 of the 2 transplanted participants. No deaths and no serious adverse events were reported among the 10 enrolled over 24 months. Read this as a very small transplant experience, not a 10-patient efficacy readout.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- To demonstrate the safety and efficacy of islet transplantation under alemtuzumab induction for treatment of Type-1 Diabetes (T1D) in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes.
The full picture
What was tested
Islet transplantation takes the insulin-producing islet cells from a deceased donor's pancreas and infuses them into the recipient's liver, where they can start sensing glucose and releasing insulin again. This Northwestern University study was a single-centre phase 3 trial in adults (18-65) with type 1 diabetes who had hypoglycaemia unawareness and a history of severe lows, and who did not have kidney failure ("non-uremic") — so the transplant was being asked to justify itself on hypoglycaemia grounds alone, not as an add-on to a kidney transplant. Immune induction used alemtuzumab (Campath).1
What happened
The trial ran from June 2012, reached primary completion in July 2021, and completed in February 2025. Results were first posted to ClinicalTrials.gov in June 2026.1
The most important thing in the posted results is the participant flow. 105 people were screened and 10 were enrolled — but only 2 actually received an islet infusion. The other 8 did not complete the study and were never transplanted (posted reason: "patient not transplanted"). Donor availability, staying eligible while waiting, and accepting lifelong immunosuppression are general challenges with this approach — noted here as context, not as registry-reported causes — and this trial shows how much attrition that creates.1
The posted primary outcome — being free of severe hypoglycaemic events two years after the final islet transplant — was met by 2 of the 2 transplanted participants. Across all 10 enrolled participants, no deaths and no serious adverse events were reported over 24 months.1
How to read this
A denominator of two is not an efficacy result. It is consistent with published donor-islet series — which have reported freedom from severe hypoglycaemia in transplanted recipients — but this trial on its own cannot tell you how well islet transplants work. What it does illustrate clearly is a practical bottleneck the field is trying to design around: donor supply and the burden of immunosuppression are what limit the scaling of donor-islet transplantation — a site interpretation of the attrition seen here, not a registry finding. That supply-and-immunosuppression problem is precisely what stem-cell-derived islets and encapsulation or hypoimmune approaches are built to solve.
Sources
- [1]NCT01897688: Single-center phase 3 islet transplantation in non-uremic T1D · Trial registry
Northwestern University. A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients — protocol, eligibility and induction regimen. ClinicalTrials.gov, NCT01897688 (live-checked 27 August 2026).
Northwestern University. NCT01897688 — posted results (participant flow, primary outcome measure, adverse events); study completed 2025-02, results first posted 2026-06-18. ClinicalTrials.gov (live-checked 27 August 2026).
- [2]NCT01897688 posted results: participant flow, outcome measures and adverse events · Trial registry · 2026-06-18 — Results first posted 2026-06-18. Records 105 screened, 10 enrolled, 2 transplanted; primary outcome reported on the 2 transplanted participants.