NCT07126873
A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
Recruiting · Phase 1, Phase 2 · EndoCell Therapeutics, Inc. · registry updated 2025-08-22
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
- Clinical history of Type 1 Diabetes with \> 5 years of duration
- 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:
- At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;
- Unaware hypoglycemia evaluated using the Clarke scoring system
- Willing and able to conduct self-blood glucose monitoring as required, with good compliance
Exclusion
- 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