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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)

Study on Safety and Efficacy of Investigational Treatment for Type 1 Diabetes

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

This study investigates the safety and efficacy of implanting pancreatic endocrine cell clusters into the omentum of patients with Type 1 diabetes who experience severe hypoglycemia. The study aims to evaluate how well the treatment works and how long it lasts, along with determining the best dose. Participants will need to undergo immunosuppression to prevent rejection of the implanted cells.

  • Who can participate: Adults aged 18 to 65 years with Type 1 diabetes, diagnosed before age 40, who have been insulin-dependent for at least 5 years and experience recurrent severe hypoglycemia can participate. They must also be willing to use continuous glucose monitoring.
  • Study details: Participants will be monitored for safety and effectiveness.
Updated on 22 Jun 2025. Study ID: SR-02-201

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