NCT06651515

A Study of the Safety and Efficacy of Pancreatic Endocrine Cell Clusters Implanted Into the Omentum of Type 1 Diabetes Patients With Severe Hypoglycemia

A Phase 1/2 Adaptive Dose Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Seraxis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.

Conditions

• Diabetes Mellitus Type 1

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Pancreatic Endocrine Cell Clusters	Allogeneic Pancreatic Endocrine Cell Clusters

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2024-10-21
• Last updated: 2025-10-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study