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 of implanted pancreatic endocrine cells for type 1 diabetes with severe low blood sugar
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
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Age: 18 years - 65 years
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Gender: All
The purpose of this research study is to learn about the safety and effects of implanted pancreatic endocrine cell clusters in people with type 1 diabetes who have severe, repeated episodes of low blood sugar (hypoglycemia). The study will also look at how long the treatment effects may last and what dose may work best.
Participants will receive pancreatic endocrine cell clusters placed into the omentum (a layer of tissue in the belly). Participants will also need to take immune-suppressing medicines to help prevent the body from rejecting the implanted cells. The study is open to people with any HLA type or blood type.
Who can participate:
People with type 1 diabetes and severe recurrent hypoglycemia may be able to participate if they:
- Have type 1 diabetes
- Have severe, repeated episodes of low blood sugar
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