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Study is being withdrawn for business reasons
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SR-02 Allogeneic pancreatic endocrine cell clusters | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Pancreatic Endocrine Cell Clusters | Biological | Allogeneic Pancreatic Endocrine Cell Clusters |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 90 day intervals through day 365 |
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Key Inclusion Criteria
Key Exclusion Criteria
Other protocol defined Inclusion/Exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| UPMC Presbyterian Shadyside |
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| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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