Assessing the Safety and Efficacy of the Gastric Submucosal Space in 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 the current procedure and are lost around the time of transplant. We are looking for an alternate site to transplant the islets into the body. This research study is testing a new transplant procedure that may help prevent this islet cell loss. The new procedure involves injecting the islets beneath the lining of the stomach (‘submucosal space’) instead of into the liver.

If you participate in the study, you will receive your islet transplantation under this new procedure. After the transplant, you will be followed clinically under Standard of Care for islet transplant patients. 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.

Patient Eligibility

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.