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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Allogeneic pancreatic endocrine cell clusters
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.
Safety variables include the percentage, severity, and relatedness of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) from the SR-02 implant to Day 365.
Time frame: Day 35 to Day 365
Change in C-peptide secretion from baseline.
Outcome will be measured by mixed-meal tolerance test (MMTT)-stimulated C peptide at 3-month intervals.
Time frame: Enrollment to Day 365
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.