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

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.

Key Inclusion Criteria

• Adult 18 to 65 years with a clinical history of T1D
• Diagnosis of T1D at <40 years of age
• insulin dependence for ≥5 years at pre-screening
• Recurrent severe hypoglycemia
• Willingness to use continuous glucose monitoring

Key Exclusion Criteria

• Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening
• Weight loss medication(s) within 3 months of Screening

Other protocol defined Inclusion/Exclusion criteria may apply