B-Lymphocyte Immunotherapy in Islet Transplantation: Single Subject Modification to Calcineurin-Inhibitor Based Immunosuppression for Initial Islet Graft (CIT-0501)

NCT01049633 NO_LONGER_AVAILABLE

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 and medications to support islet survival for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	NO_LONGER_AVAILABLE

Conditions

• Type 1 Diabetes Mellitus

Interventions

• Allogeneic Pancreatic Islet Cells
• Sirolimus
• Basiliximab
• Tacrolimus
• Antibacterial, Antifungal, and Antiviral Prophylaxis
• Trimethoprim/sulfamethoxazole
• Clotrimazole
• Valganciclovir
• Heparin
• Enoxaparin

Countries

United States