Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

December 31, 2010

Study Completion Date

August 31, 2012

Conditions
Type 1 Diabetes MellitusHypoglycemia
Interventions
BIOLOGICAL

Allogeneic islets of Langerhans transplant

Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.

DRUG

Raptiva

Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;

DRUG

Sirolimus

Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated

DRUG

anti-thymocyte globulin

2.0 mg/kg on days -2, and -1 IV

Trial Locations (1)

55455

Universtiy of Minnesota, Minneapolis

Sponsors
All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

lead

University of Minnesota

OTHER