E-islet 01 therapy for people with long-standing Type 1 diabetes and impaired hypoglycemia awareness

A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of E-islet 01 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia

This trial will test whether E-islet 01, an allogeneic human islet cell therapy, is safe and helps reduce severe or unrecognized low blood sugars in people with Type 1 diabetes of more than five years’ duration.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: EndoCell Therapeutics, Inc. (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07126873 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 interventional trial enrolls participants with Type 1 diabetes for at least five years, very low C-peptide, and either impaired hypoglycemia awareness or recent severe hypoglycemia to receive allogeneic human E-islet 01. The protocol focuses on safety and tolerability while tracking effects on hypoglycemia frequency and metabolic markers such as mixed-meal stimulated C-peptide. Eligible participants must be on continuous insulin therapy and able to perform frequent self-blood glucose monitoring, and those with active systemic infections or recent malignancy are excluded. Follow-up visits and safety/efficacy assessments are conducted at the single study site in Shanghai.

Who should consider this trial

Good fit: Ideal candidates are people with Type 1 diabetes for more than five years, very low C-peptide (<0.3 ng/mL), on insulin therapy, and with impaired hypoglycemia awareness or at least one episode of severe hypoglycemia in the past year who can comply with frequent glucose monitoring.

Not a fit: People with active systemic infections, recent cancer, positive viral serology (HBsAg, HCV, HIV), or significant residual insulin production (higher C-peptide) are excluded and are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, E-islet 01 could reduce episodes of severe hypoglycemia and improve glycemic stability and quality of life for people with long-standing Type 1 diabetes.

How similar studies have performed: Allogeneic islet transplantation and other cell-based beta-cell replacement approaches have reduced severe hypoglycemia in selected patients, but these therapies remain experimental and results have been variable.

Eligibility criteria

Inclusion Criteria:

* Clinical history of Type 1 Diabetes with \> 5 years of duration
* 2-hour C-peptide level \<0.3 ng/mL after a mixed meal stimulation test
* Under continuous insulin therapy, Participants have at least one of the following conditions:

  1. At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;
  2. Unaware hypoglycemia evaluated using the Clarke scoring system
* Willing and able to conduct self-blood glucose monitoring as required, with good compliance
* Voluntarily participate and sign the informed consent form

Exclusion Criteria:

* Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab).
* History of malignancy within the past 5 years or undergoing antitumor treatment
* Participation in other clinical trials in the 3 months or islet cell transplant, organ transplant, or cell therapy in the 12 months prior to enrollment
* Other situations judged by the investigator as unsuitable for participation in the trial

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: yanyan ma

Conditions Diabetes Mellitus, Type 1; Impaired Hypoglycemic Awareness; Severe Hypoglycemia