Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes

PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

September 30, 2011

Study Completion Date

November 30, 2013

Conditions
Diabetes Mellitus, Type 1
Interventions
BIOLOGICAL

Allogeneic Pancreatic Islet Cells

Preparation of allogeneic pancreatic islet cells injected into the portal vein of the liver

DRUG

Deoxyspergualin

An anti-inflammatory agent that blocks proinflammatory cytokine production and inhibits T-cells and B-cells and affects antigen presenting cells.

BIOLOGICAL

Antithymocyte globulin

Immunosuppressive that selectively depletes activated T-cells and depletes resting T-cells in a dose-dependent manner.

BIOLOGICAL

Daclizumab or basiliximab

Will replace antithymocyte globulin in all islet transplantations after the first one

DRUG

Sirolimus

Maintenance immunosuppressive therapy

DRUG

Tacrolimus

Maintenance immunosuppressive therapy

BIOLOGICAL

Etanercept

Blocks TNF-alpha which is toxic to islet cells

Trial Locations (3)

55455

University of Minnesota, Minneapolis

60611

Northwestern University, Chicago

94143

University of Californinia, San Francisco, San Francisco

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00434850 - Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes | Biotech Hunter | Biotech Hunter