Islet Transplantation in Type 1 Diabetic Kidney Allograft
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- University of Chicago
- Study ID
- NCT01241864
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 68 Years
- Healthy Volunteers
- Not accepted
Interventions
- Allogenic islet cells (human, U. Chicago) — BIOLOGICALHuman allogenic islet cells. Immunosuppression varies but may include prograf, cellcept, sirolimus, prednisone. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.
- Intraportal infusion of islet cells — PROCEDUREIntraportal infusion of islet cell through the portal vein in the liver.
Study Details
The purpose of this study is to learn about the safety of islet transplantation when performed after kidney transplantation, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.
Key Dates
- Start date
- Dec 31, 2010
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Allogenic islet cells (human, U. Chicago)
Primary Outcome Measure
HbAlc <6.5% and an absence of severe hypoglycemic events [ Time Frame: 1 year after transplantation ]
Central Contacts
- Lindsay Basto, RN, BSN773-702-2504
- Piotr Witkowski, MD, PhD(773) 702-2447
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | Piotr Witkowski, MD, PhD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Chicago, IL
By condition
By specialty
By research site
Related Studies
- Islet Transplantation in Patients With "Brittle" Type I DiabetesRecruiting · University of Chicago · Chicago, Illinois
- A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 DiabetesPHASE3 · Recruiting · Vertex Pharmaceuticals Incorporated · Duarte, California
- A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes MellitusPHASE1/PHASE2 · Recruiting · Otsuka Pharmaceutical Factory, Inc. · Chicago, Illinois
- A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 DiabetesPHASE3 · Recruiting · Novo Nordisk A/S · Cullman, Alabama