Pancreatic Islet Transplantation Into the Gastric Submucosa

The overall objective of this pilot project is to evaluate the safety and efficacy of the gastric submucosal space as a novel site for clinical islet transplantation. Safety will be evaluated by the monitoring of side effects such as post procedural GI complications, frequency of hypo and hyperglycemic events, and immunosuppression side effects. Efficacy will be determined by accepted measures including insulin independence, long term glucose control, and reduction/elimination of hypoglycemic events. The site has several physiologic attributes that may improve the outcomes of islet transplantation compared with the conventional intraportal transplant site.