Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

September 5, 2007

Primary Completion Date

July 19, 2017

Study Completion Date

June 14, 2026

Conditions
Type 1 Diabetes Mellitus
Interventions
BIOLOGICAL

Islets of Langerhans transplantation

"Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:~Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant"

Trial Locations (1)

60612

University of Illinois at Chicago Medical Center, Chicago

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CellTrans Inc.

INDUSTRY