LEA29Y (Belatacept) Emory Edmonton Protocol

Phase 2 Completed 10 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Clinical Islet Transplantation Consortium · collab

NaSingle-groupOpen-labelTreatment

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 using a steroid-free, calcineurin-inhibitor-free belatacept based immunosuppressive medication, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.

Timeline

Start: 2008-10
Primary completion: 2012-04
Completion: 2013-04

Publications

Gala-Lopez B, Kin T, O'Gorman D, Pepper AR, Senior P, Humar A, Shapiro AM. Microbial contamination of clinical islet transplant preparations is associated with very low risk of infection. Diabetes Technol Ther. 2013 Apr;15(4):323-7. doi: 10.1089/dia.2012.0297. Epub 2013 Feb 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Allogeneic Pancreatic Islet Cells	Cell therapy	4000 iu/kg	Other
Subject	Allogeneic Pancreatic Islet Cells	Cell therapy	5000 iu/kg	Other
Background	Basiliximab	Monoclonal antibody	20 mg	Intravenous
Background	Belatacept	Protein / enzyme biologic	5 mg/kg	Intravenous
Background	Mycophenolate Mofetil	Small molecule	1 g	Oral
Background	Tacrolimus	Small molecule	—	Oral

LEA29Y (Belatacept) Emory Edmonton Protocol

Summary

Timeline

Publications

Drugs

Indications