Islet Transplantation in Type 1 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

September 30, 2012

Study Completion Date

May 31, 2014

Conditions
Type 1 Diabetes Mellitus
Interventions
BIOLOGICAL

Allogeneic Pancreatic Islet Cells

200 ml suspension of allogenic human purified islets

BIOLOGICAL

Antithymocyte Globulin

Participants will begin receiving ATG 2 days prior to the first islet transplant. ATG will continue to be given until Day 2 post-transplant.

DRUG

Sirolimus

Participants will begin receiving sirolimus 2 days prior to the first islet transplant and will be given for the duration of the study.

DRUG

Tacrolimus

On Day 1 post-transplant, participants will receive tacrolimus, which will also be taken for the duration of the study.

BIOLOGICAL

Etanercept

Etanercept will be taken on the day of transplant and Days 3, 7, and 10 post-transplant.

PROCEDURE

Islet Transplantation

Transplantation of pancreatic islet cell

BIOLOGICAL

Basiliximab

Basiliximab will be used in place of ATG for the second and third transplants, if they are necessary.

Trial Locations (8)

19104

University of Pennsylvania, Philadelphia

30322

Emory University, Atlanta

33136

University of Miami, Miami

55455

University of Minnesota, Minneapolis

60611

Northwestern University, Chicago

60612

University of Illinois, Chicago, Chicago

94143

University of Callifornia, San Francisco, San Francisco

T6G028

University of Alberta, Edmonton

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

NCT00434811 - Islet Transplantation in Type 1 Diabetes | Biotech Hunter | Biotech Hunter