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

Recruiting
18 years - 65 years
All
Phase 1/2
9 participants needed
3 Locations

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetes Mellitus Type 1
  • Age: 18 years - 65 years
  • Gender: All

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

Updated on 22 Jun 2025. Study ID: SR-02-201

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