BMX - 010 Preservation of Islet Cell Mass and Function for Clinical Islet Transplantation
An Outline of This Clinical Trial
Islet transplantation is a procedure used in people with difficult to control Type 1 diabetes. Insulin producing cells (islets) are isolated from a pancreas of a deceased organ donor. After the cells are carefully prepared, the islets are transplanted into your liver. These transplanted islets may produce insulin. We have learned that some of these cells do not survive through the preparation process. We are looking for medications to be used through the preparation process, which would minimize cell death. BMX-010 is a new drug, a metalloporphyrine which we believe will help islets survive and keep them healthy and functioning prior to transplantation.
If you choose to participate, you will receive islets for transplant that have been treated with BMX-010 through the islet isolation process. BMX-010 will not be given to you as medication. After the transplant, you will be followed clinically under Standard of Care. Study staff will review your clinical chart and the routine testing (including any blood work, imaging, insulin dosing, glucose monitoring records, hypoglycemia assessments) which you will complete at routine follow-ups.
You may be eligible for this study if you are an adult (ages 18 to 68) with Type 1 diabetes (diagnosed for at least 5 years), assessed and deemed appropriate to activate on the waiting list for islet transplantation at the Clinical Islet Transplant Program.