E-islet 01: allogeneic human regenerative islet therapy
What this study tests
EndoCell Therapeutics' Phase 1/2a trial of allogeneic human E-islet 01 in adults with long-standing T1D, impaired hypoglycemia awareness, and severe hypoglycemia. The cells are infused into the hepatic portal vein and the study follows safety plus severe-hypoglycemia/HbA1c outcomes for up to 5 years. No registered trial results are posted yet.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2025-08-22.
Most recent recorded citation date: 2026-02-26. 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?
- Adults aged 18-75 with type 1 diabetes of over 5 years' duration and severe hypoglycemia and/or impaired awareness of hypoglycemia (the registry requires at least one of the two); one listed site at Shanghai Changzheng Hospital. 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
- No posted results for the registered E-islet 01 trial yet. A 2026 Lancet Diabetes & Endocrinology report describes early autologous/allogeneic stem-cell-derived islet therapy experience in three T1D recipients, but it should not be treated as completed trial evidence for this 21-participant registry study. Separately, the platform's famous 2024 "autologous cure" was a man with type 2 diabetes who was already on chronic immunosuppression for a prior kidney transplant — it is not evidence of a drug-free graft, and it is not Type 1 evidence.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: Other regions. 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
- Safety and tolerability: number of participants with adverse events and serious adverse events from infusion to end of study (up to 5 years)
- Proportion of participants free of severe hypoglycemic events with HbA1c under 7.0% or at least 1 percentage-point HbA1c reduction at 1 year after E-islet 01 infusion
The full picture
What is being tested
E-islet 01 is a cell-replacement therapy: allogeneic human regenerative islets infused into the hepatic portal vein.1 The trial targets adults with established T1D and severe hypoglycemia problems, the same high-risk population for whom donor-islet and stem-cell-islet replacement is intended.1
Design
The study is open-label and sequential, with 21 planned participants at Shanghai Changzheng Hospital.1 Primary outcomes cover adverse events/serious adverse events through the full study and the proportion of participants free of severe hypoglycemia with HbA1c under 7.0% or at least a 1 percentage-point reduction at 1 year after infusion.1
Readout status
No results are posted for NCT07126873. The 2026 Lancet Diabetes & Endocrinology report of stem-cell-derived islet therapy in three T1D recipients is a useful platform signal, but the E-islet 01 trial still needs its own safety, C-peptide, insulin-dose, and durability data.2
What the famous E-islet case does not show
The story attached to this platform in the press is a man who came off insulin 11 weeks after receiving islets grown from his own cells, with no rejection. Check it against the paper: he had type 2 diabetes, and he had received a kidney transplant in 2017 for end-stage diabetic nephropathy — so he was already taking chronic systemic anti-rejection drugs when the autologous E-islets went in.3 Type 2 evidence does not score a Type 1 record here, and an already-immunosuppressed recipient tells you nothing about whether a graft survives without drugs. Autologous cells remove the rejection problem; they leave the autoimmunity that causes T1D entirely intact. The registered E-islet 01 study uses allogeneic cells and does not describe an immunosuppression-free protection strategy at all.1
Sources
- [1]
- [2]Autologous and allogeneic stem cell-derived islet therapy in three recipients with type 1 diabetes and complete loss of endogenous pancreatic beta-cell function pretransplant · Peer-reviewed study · 2026-02-26
Shi Y, Feng Y, Li T, et al. Autologous and allogeneic stem cell-derived islet therapy in three recipients with type 1 diabetes and complete loss of endogenous pancreatic beta-cell function pretransplant. Lancet Diabetes Endocrinol (2026).
- [3]Treating a type 2 diabetic patient with impaired pancreatic islet function by personalized endoderm stem cell-derived islet tissue · Peer-reviewed study · 2024-04-30 — The autologous E-islet case: a 59-year-old man with type 2 diabetes and a 2017 kidney transplant, therefore already on chronic systemic immunosuppression when the E-islets were transplanted.
Wu J, Li T, Guo M, et al. Treating a type 2 diabetic patient with impaired pancreatic islet function by personalized endoderm stem cell-derived islet tissue. Cell Discovery (30 April 2024). "The patient was a 59-year-old man with a 25-year history of T2D who developed end-stage diabetic nephropathy and underwent kidney transplantation in June of 2017."