A Phase 1/2 Adaptive Dose Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SR-02 Allogeneic pancreatic endocrine cell clusters
Intervention: Allogeneic Pancreatic Endocrine Cell Clusters (Biological)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported