E-islet 01: allogeneic human regenerative islet therapy
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.
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
Results so far
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.
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 in which donor-islet and stem-cell-islet replacement can make a practical difference.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 improvement 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
References
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EndoCell Therapeutics, Inc. A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes. ClinicalTrials.gov NCT07126873. https://clinicaltrials.gov/study/NCT07126873 ↩ ↩2 ↩3 ↩4 ↩5
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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). https://doi.org/10.1016/S2213-8587%2825%2900423-1 ↩
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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." https://doi.org/10.1038/s41421-024-00662-3 ↩