A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of E-islet 01 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Shanghai Changzheng Hospital
RECRUITING
Shanghai
Contact Information
Primary
yanyan ma
mayanyan@endocell.cn
+8618621591910
Time Frame
Start Date: 2025-08-11
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 21
Treatments
Experimental: Allogeneic Human E-islet (E-islet 01)
Related Therapeutic Areas
Sponsors
Leads: EndoCell Therapeutics, Inc.