Diabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia
Investigational drug(s) / intervention(s)
Allogeneic Human E-islet (E-islet 01)
Allogeneic Human E-islet (E-islet 01): Allogeneic Human E-islet (E-islet 01), Infused into the hepatic portal vein
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — From E-islet 01 infusion to end of study (up to 5 years)
Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycated Haemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in Glycosylated hemoglobin(HbA1c) From Baseline — At 1 year after E-islet 01 infusion
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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