drugset / Trial / NCT00679042
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
NaSingle-groupOpen-labelTreatment
Summary
In an earlier Phase 1/2 clinical trial using the Edmonton Protocol of steroid free immunosuppression, investigators at University of Illinois at Chicago (UIC) demonstrated the safety of islet preparation, iset transplantation, and medical treatment at UIC. Therefore, the primary purpose of the present Phase 3 clinical trial is to demonstrate the safety and efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic patients using the UIC protocol that was developed and proven effective during the Phase 1/2 clinical trial.
Timeline
- Start
- 2007-09-05
- Primary completion
- 2017-07-19
- Completion
- 2026-06-14
Publications
- Ajmal N, Bogart MC, Khan P, Max-Harry IM, Healy AM, Nunemaker CS. Identifying Promising Immunomodulators for Type 1 Diabetes (T1D) and Islet Transplantation. J Diabetes Res. 2024 Dec 20;2024:5151171. doi: 10.1155/jdr/5151171. eCollection 2024.
- Luu QF, Villareal CJ, Fritschi C, Monson RS, Oberholzer J, Danielson KK. Concerns and hopes of patients with type 1 diabetes prior to islet cell transplantation: A content analysis. J Diabetes Complications. 2018 Jul;32(7):677-681. doi: 10.1016/j.jdiacomp.2018.04.002. Epub 2018 Apr 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Islets of Langerhans | Cell therapy | — | — |
| Background | Basiliximab | Monoclonal antibody | 20 mg | Intravenous |
| Background | Etanercept | Protein / enzyme biologic | 25 mg | Intravenous |
| Background | Exenatide | Peptide | 10 ug | Subcutaneous |
| Background | Sirolimus | Small molecule | 0.1 mg/kg | Oral |
| Background | Tacrolimus | Small molecule | 1 mg | Oral |