At a glance
ClinicalIndex Comparison Record- ✓Type 1 diabetes mellitus with severe incapacitating hypoglycemic episodes (requiring assistance or hypoglycemia unawareness with glucose <54 mg/dL)
- ✓Poor diabetes control (HbA1c >8.0% but <12%) despite intensive insulin therapy (self-monitoring ≥4 times/day, ≥3 insulin injections/day or pump, endocrinologist monitoring)
- ✓Progressive diabetic complications (retinopathy, neuropathy, nephropathy, cardiovascular disease) with chronically poor glycemic control
- ✕Age <18 or >65 years
- ✕Diabetes duration <5 years
- ✕BMI >26 kg/m² or weight >80 kg
- ✕Insulin requirement >1.0 u/kg/day
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Steroid-free and Long-term Calcineurin-free Trial in Islet Cell Transplantation
In Brief
A Phase 2 clinical trial evaluating Islet transplantation for Type 1 Diabetes Mellitus. Completed, enrolled 3 participants across 1 site.
Detailed Summary
The purposes of this study are: 1. To reverse hyperglycemia and insulin dependency in patients with type 1 diabetes mellitus through islet transplantation utilizing steroid free, calcineurin-inhibitor free immunosuppression. 2. To assess the long-term function of successful islet transplants in patients with type 1 diabetes mellitus utilizing islets that have undergone a period of culture. 3. To determine whether the natural history of the microvascular, macrovascular, and neuropathic complications are altered following the successful transplantation of islets.
Study Details
Timeline
Interventions
Islet transplantation