At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 8 enrolled
Drug / intervention
Transplantation of Human Isletsdrug
Likely dose
Human islets, at least 9,000 islet equivalents per kilogram of body weightAI-extracted
Key inclusion· 6
- ✓Type 1 diabetes mellitus diagnosed more than 5 years previously
- ✓Age 18 to 65 years
- ✓BMI ≤26
- ✓Intensive insulin therapy (≥3 injections daily or insulin pump)
Key exclusion· 15
- ✕Renal dysfunction
- ✕Severe cardiac disease: recent MI (within 6 months), non-correctable coronary artery disease, or ischemia on stress echo
- ✕Current bacterial or fungal infection
- ✕Macroproteinuria
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Islet Transplantation in Type 1 Diabetes Using the Edmonton Protocol of Steroid Free Immunosuppression
In Brief
A Phase 2 clinical trial evaluating Transplantation of Human Islets for Diabetes Mellitus, Type 1. Completed, enrolled 8 participants across 1 site.
Detailed Summary
This trial will study the ability of islet transplantation to restore glycemic control and achieve insulin independence in type 1 diabetic subjects with life-threatening hypoglycemia and unawareness, or recurrent hyperglycemia with ketoacidosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation
Timeline
Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2002
First PostedAug 2005
Primary CompletionDec 2014
TodayJul 2026
First PostedAug 24, 2005
Enrollment StartJul 1, 2002
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 12.4 yearsPosted 20.9 years ago
Interventions
Transplantation of Human Isletsdrug
Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure