Islet Transplantation in Type 1 Diabetic Patients Using the Edmonton Protocol of Steroid Free Immunosuppression

Phase 1/2 Completed 10 enrolled University of Illinois at Chicago

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of this study is to demonstrate the safety of allogeneic islet transplantation in type 1 diabetic patients performed at the University of Illinois at Chicago (UIC). The purpose is to reproduce the Edmonton protocol to demonstrate that pancreatic islets isolated at UIC are safe and of sufficient quality to provide reproducible graft function.

Timeline

Start: 2004-11
Primary completion: 2010-07-05
Completion: 2020-07-15

Publications

Results Gangemi A, Salehi P, Hatipoglu B, Martellotto J, Barbaro B, Kuechle JB, Qi M, Wang Y, Pallan P, Owens C, Bui J, West D, Kaplan B, Benedetti E, Oberholzer J. Islet transplantation for brittle type 1 diabetes: the UIC protocol. Am J Transplant. 2008 Jun;8(6):1250-61. doi: 10.1111/j.1600-6143.2008.02234.x. Epub 2008 Apr 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Etanercept	Protein / enzyme biologic	25 mg	Intravenous
Comparator	Exenatide	Peptide	10 ug	Subcutaneous
Comparator	Islet Cell Transplant	Cell therapy	—	Other
Comparator	Basiliximab	Monoclonal antibody	20 mg	Intravenous
Comparator	Daclizumab	Monoclonal antibody	1 mg/kg	Intravenous
Comparator	Sirolimus	Small molecule	—	Oral
Comparator	Tacrolimus	Small molecule	—	Oral

Islet Transplantation in Type 1 Diabetic Patients Using the Edmonton Protocol of Steroid Free Immunosuppression

Summary

Timeline

Publications

Drugs

Indications