At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 10 enrolled
Drug / intervention
Islet Cell Transplantbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
In Brief
A Phase 3 clinical trial evaluating Islet Cell Transplant for Type 1 Diabetes and Severe Hypoglycemic Unawareness. Completed, enrolled 10 participants across 1 site.
Detailed Summary
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes, Severe Hypoglycemic Unawareness
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
First PostedJul 2013
Primary CompletionJul 2021
Study CompletionFeb 2025
TodayJul 2026
First PostedJul 12, 2013
Enrollment StartJun 1, 2012
Primary CompletionJul 1, 2021
Study CompletionFeb 1, 2025
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 13.0 years ago
Interventions
Islet Cell Transplantbiological