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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 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. | 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. | Enrollment to Day 365 |
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Key Inclusion Criteria
Key Exclusion Criteria
Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Contact | 240-308-8681 | info@seraxis.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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