A Study of the Safety and Efficacy of Pancreatic Endocrine Cell Clusters Implanted Into the Omentum of Type 1 Diabetes Patients with Severe Hypoglycemia
Phase 1
Not yet recruiting
- Conditions
- Diabetes Mellitus Type 1
- Interventions
- Biological: Allogeneic Pancreatic Endocrine Cell Clusters
- Registration Number
- NCT06651515
- Lead Sponsor
- Seraxis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
Not provided
Read More
Exclusion Criteria
Not provided
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SR-02 Allogeneic pancreatic endocrine cell clusters Allogeneic Pancreatic Endocrine Cell Clusters -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
UPMC Presbyterian Shadyside
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States