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
Allogeneic Pancreatic Endocrine Cell Clusters
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States
To investigate the safety and tolerability based on the percentage and relatedness of all treatment emergent adverse events and serious adverse events (TEAEs and SAEs)
Time frame: day 35 through day 365
The effect on endogenous insulin secretion as assessed by 90-minute MMTT-stimulated C-peptide >0.5 ng/ml (>0.17 nmol/L)
Time frame: 90 day intervals through day 365
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