NCT07126873

A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: EndoCell Therapeutics, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Type 1
• Impaired Hypoglycemic Awareness
• Severe Hypoglycemia

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Human E-islet (E-islet 01)	Allogeneic Human E-islet (E-islet 01), Infused into the hepatic portal vein

Timeline

• Start date: 2025-08-11
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2025-08-17
• Last updated: 2025-08-22

Locations

1 site across 1 country: China