A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
NCT01897688 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2024-03-19
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.
Conditions
- Type 1 Diabetes
- Severe Hypoglycemic Unawareness
Interventions
- BIOLOGICAL
-
Islet Cell Transplant
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Daniel Borja-Cacho, MD · Northwestern University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-06-30
- Primary Completion
- 2025-03-31
- Completion
- 2027-03-31
Countries
- United States
Study Locations
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