UW Health's islet cell transplant study trial is designed to study the effectiveness of islet transplantation in eliminating the need for insulin injections for treatment of patients with Type I diabetes mellitus. It will include two types of patients: those who have had prior transplants and those who have not. Eligible patients must have poorly controlled diabetes and not be candidates for or not favor pancreas transplantation as a treatment option.

 

 

This pilot trial will enroll a total of 16 subjects, 8 subjects in each group. Subjects in both groups will be treated with immunosuppressive medications to prevent rejection of their islet transplant that includes tacrolimus, sirolimus, and daclizumab, the same medications that were effective in islet transplantation in an Edmonton, Canada islet transplant study. Steroids will not be used in this trial.

 

Subjects in both groups will be randomly assigned (like the flip of a coin) to receive or not to receive pioglitazone by mouth once daily before and after islet transplantation. It is hoped that this medication will improve islet transplant function

 

 

Subjects will be followed carefully for at least two years after transplant for side effects, complications, and islet function. Some subjects may require more than one (and up to three) islet transplant procedures. We do not know in which individuals this will be necessary. Insulin will be administered after transplant for a variable period of time and until the transplanted islets begin to work.

 

A transplant coordinator will be assigned to each subject to facilitate follow-up care and assist with post-transplant clinic visits and monitoring.