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.
Age range
18 Years – 65 Years
Sex
ALL
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To investigate the safety and tolerability of SR-02 when implanted in subjects with T1D and Level 3 hypoglycemia as assessed by CIT-TCAE v5.0.
Timeframe: Day 35 to Day 365
Change in C-peptide secretion from baseline.
Timeframe: Enrollment to Day 365