A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
Recruiting now · Phase 1/Phase 2
Conditions studied: Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia
In brief
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
Key facts
- Study ID
- NCT07126873
- Run by
- EndoCell Therapeutics, Inc.
- People needed
- 21
- Starts
- 2025-08-11
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- 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
- Voluntarily participate and sign the informed consent form
You may not qualify if…
- 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 it is running
- Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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