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Trial intelligence / Profile preview
Islet Transplantation in Non-uremic Diabetic Patients
NCT01897688Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2012
- Primary completion
- Jul 2021
- Countries
- 1
- Sponsor
- Northwestern University
- Modality
- Stem Cell Therapies
- Drugs
- islet transplantation
- Conditions
- type 1 diabetes mellitus (T1D)
01
Overview
Phase 3, open-label, single-arm trial of islet transplantation in type 1 diabetes mellitus (T1D), sponsored by Northwestern University. Primary endpoint: Safety and Feasibility of Islet Transplantation at 2 years. Started Jun 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Islet Cell Transplant
All qualified subjects will be put on United Network for Organ Sharing (UNOS) Islet Transplant wait list for potential islet cell transplant.
03
Who it enrols
Adults 18-65 with Type 1 Diabetes for >=5 years, insulin-dependent, with severe hypoglycemia unawareness or previous islet transplant recipients returning to insulin. Excludes BMI > 30, HbA1c > 10%, poor renal function, active infections, and recent malignancies.
04
Endpoints
Primary
Safety and Feasibility of Islet Transplantation
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