Actively Recruiting
A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
Led by EndoCell Therapeutics, Inc. · Updated on 2025-08-22
21
Participants Needed
1
Research Sites
229 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 with > 5 years of duration
- 2-hour C-peptide level <0.3 ng/mL after a mixed meal stimulation test
- Under continuous insulin therapy
- At least one episode of documented severe hypoglycemia in the past 12 months or unaware hypoglycemia evaluated by Clarke scoring
- Willing and able to conduct self-blood glucose monitoring with good compliance
- Voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Uncontrolled systemic infections including pulmonary tuberculosis, active hepatitis, positive hepatitis B surface antigen, hepatitis C virus antibody, HIV antibody, or Treponema pallidum antibody
- 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 past 12 months
- Any condition judged by the investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
yanyan ma
CONTACT
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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