Actively Recruiting
A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of E-islet 01 in Adults With Type 1 Diabetes Mellitus, Impaired Hypoglycemic Awareness, and Severe Hypoglycemia
Led by EndoCell Therapeutics, Inc. · Updated on 2025-08-22
21
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of a treatment called E-islet 01 in adults with Type 1 Diabetes who have difficulty recognizing low blood sugar (impaired awareness of hypoglycemia) and experience severe low blood sugar events. This Phase 1/2a study aims to better understand how this biological treatment works for this specific group of participants. Participants will receive an infusion of Allogeneic Human E-islet (E-islet 01) into the hepatic portal vein. The study will follow participants for up to five years to monitor safety and treatment effects. Key measures include the number of severe hypoglycemic events and changes in blood sugar control one year after infusion. During the study, participants will be closely monitored for adverse events and changes in blood sugar control, including measurements of glycated hemoglobin (HbA1c) and C-peptide levels. Other outcomes include time spent with blood sugar in range and insulin independence or reduction. Participants will perform self-blood glucose monitoring and be evaluated regularly to assess treatment response and safety over the full duration of the trial.
CONDITIONS
Brief Title
A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical history of Type 1 Diabetes lasting more than 5 years
- 2-hour C-peptide level less than 0.3 ng/mL after a mixed meal stimulation test
- On continuous insulin therapy
- At least one episode of severe hypoglycemia in the past 12 months or impaired hypoglycemia awareness evaluated by Clarke scoring
- Willing and able to conduct self-blood glucose monitoring with good compliance
- Willing to voluntarily participate and sign informed consent
You will not qualify if you...
- Uncontrolled systemic infections, including pulmonary tuberculosis, active hepatitis, or positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- History of cancer within the past 5 years or currently receiving antitumor treatment
- Participation in other clinical trials within the past 3 months or islet cell, organ transplant, or cell therapy within the past 12 months
- Other conditions deemed unsuitable by the investigator for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years
Participants receive an infusion of Allogeneic Human E-islet (E-islet 01) into the hepatic portal vein as the active intervention.
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
yanyan ma
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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