At a glance
ClinicalIndex Comparison Record- ✓Type 1 diabetes for >5 years with hypoglycemic unawareness (unable to sense hypoglycemia until blood glucose <54 mg/dL)
- ✓Type 1 diabetes for >5 years with metabolic instability: ≥2 episodes of severe hypoglycemia (requiring assistance, glucose <54 mg/dL) or ≥2 hospital visits for DKA in the past year
- ✓Type 1 diabetes for >5 years with progressive secondary complications (retinopathy, nephropathy, or neuropathy) despite optimal glucose control efforts
- ✓Age 18-65 years
- ✕Severe cardiac disease: recent MI within 6 months, non-correctable coronary artery disease, or ischemia on functional exam
- ✕Active alcohol or substance abuse, including cigarette smoking within past 6 months
- ✕Psychiatric conditions preventing transplant candidacy (uncontrolled/unstable schizophrenia, bipolar disorder, or major depression)
- ✕Active infection: hepatitis C, hepatitis B, HIV, or tuberculosis (or under treatment for suspected TB)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Islet Transplantation for Type 1 Diabetic Patients Using the Edmonton Protocol of Steroid Free Immunosuppression (ITN005CT)
In Brief
A Phase 2 clinical trial evaluating Islet Transplantation, Sirolimus, and 6 other interventions for Diabetes Mellitus, Insulin-Dependent. Completed, enrolled 36 participants across 9 sites in 5 countries.
Detailed Summary
The purpose of this study is to test whether the islet cell transplantation procedures and results from a previous study in Edmonton, Canada, can be repeated. The study also is designed to learn more about diabetes control using islet cell transplantation. This is a Phase I/II study (a study that examines effectiveness and looks for side effects). The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal, despite intensive insulin therapy. A recent study conducted in Edmonton, Canada, was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated. This study extends the results obtained from the Edmonton study, which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression.
Study Details
Timeline
Interventions
Participants will receive portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. Up to three transplants are possible depending on individual results.
Administered at a dose of 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing will be adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.
Administered at a dose of 1 mg by mouth once pre-transplantation followed by 1 mg twice daily post transplantation. Levels will be adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
Administered at a dose of 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation, totaling 5 doses(over 8 weeks). Further daclizumab dosing may be necessary based on individual results and islet transplantation needs.
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