A PILOT STUDY OF EFFICACY OF ISLET TRANSPLANTATION IN TYPE I DIABETES

点击翻译按钮获取中文摘要

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The prevalence of type I diabetes in the U.S. is estimated to be about 800,000 individuals. There are no thoroughly preventative or curative measures currently available. Islet transplantation is safe, but until recently, has not been routinely effective in ameliorating type I diabetes. The University of Alberta in Edmonton, Canada has had recent success with islet cell transplantation using the immunousuppression regimen of sirolimus, tacrolimus and IV zenapax, without corticosteroids. These agents are commonly used in transplantation. The Edmonton study revealed the need for two donor pancreases in order to achieve insulin independence. Patients were immunosuppressed for less than twelve weeks prior to their second islet cell transplant. It is unclear whether insulin independence would have been achieved from one donor pancreas had the patients been immunosuppressed for a longer duration prior to retransplantation. The mass of islet cells may not be the determining factor for successful transplantation. This study builds on the strengths of the Edmonton experience. The approach is to perform islet cell transplants into type I diabetic patients from our kidney transplant population that are already immunosuppressed. These patients have been on a stable immunosuppression regimen of tacrolimus and sirolimus without corticosteroids prior to islet cell transplantation. This feasibility study will limit accrual to five patients that will be followed for at least one year post islet transplantation. The most important endpoint to be observed will be the frequency and duration of insulin-independence following islet transplantation in these currently immunosuppressed patients.