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Phase 1/2RecruitingNCT07126873

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.

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

References

  1. 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

  2. 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 ↩