A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes

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 study will evaluate the safety, tolerability and efficacy of E-islet 01 in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia

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