Allogeneic Islet Cells Transplanted Onto the Omentum
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hypoglycemia
- Hypoglycemia Unawareness
- Type 1 Diabetes Mellitus
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
Islet transplantation will be performed in subjects with unstable Type 1 diabetes mellitus under permanent immunosuppression. Islets are re-suspended in autologous plasma and distributed on the omental surface by a minimal invasive approach. Cell adherence is achieved by addition of clinical-grade r...
Islet transplantation will be performed in subjects with unstable Type 1 diabetes mellitus under permanent immunosuppression. Islets are re-suspended in autologous plasma and distributed on the omental surface by a minimal invasive approach. Cell adherence is achieved by addition of clinical-grade recombinant human thrombin that reacts with plasma to create a biocompatible, degradable gel containing the islet graft. The primary efficacy endpoint is the proportion of subjects with HbA1c ≤6.5% at 1 year AND free of severe hypoglycemic events from Day 28 to Day 365, inclusive, after the islet transplant. The primary safety endpoint is to demonstrate patient safety throughout all stages of the trial.
Tracking Information
- NCT #
- NCT02213003
- Collaborators
- Juvenile Diabetes Research Foundation
- Diabetes Research Institute Foundation
- Investigators
- Principal Investigator: Rodolfo Alejandro University of Miami
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