Device-Less Technique in Islet Transplantation

PHASE1CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

March 22, 2022

Primary Completion Date

February 6, 2023

Study Completion Date

March 11, 2025

Conditions
Type 1 Diabetes
Interventions
PROCEDURE

Implantation of Nylon catheter (Device-less sentinel unit)

"Implantation of the Device-Less sentinel units. Ultrasound monitoring will be performed after Device-Less implantation. Standard Islet cell Transplantation: Will occur simultaneously Portal islet transplantation and subcutaneous islet transplantation in the Device-Less sentinel spaces.~Islets are maintained for a minimum of 6 hours up to 72 hours in supplemented CMRL1066-based media until the time of transplant.~Concomitant to portal vein infusion, islet transplantation will occur in all four (4) DL sentinel spaces.~To explant a unit, the Surgeon will make an incision and then carefully dissect the tissue engrafted around the transplant. The entire transplant site and any adherent tissue capsule can then be removed entirely from the pocket."

Trial Locations (1)

T6G 2E1

University of Alberta Clinical Islet Transplant Program, Edmonton

Sponsors
All Listed Sponsors
collaborator

Juvenile Diabetes Research Foundation

OTHER

lead

University of Alberta

OTHER