At a glance
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Allogeneic Islet Cells Transplanted Onto the Omentum
In Brief
A Phase 2 clinical trial evaluating Islet transplantation for Type 1 Diabetes Mellitus and 2 related conditions. Completed, enrolled 3 participants across 1 site.
Detailed Summary
Current islet transplantation into the portal vein of the liver has shown the unique ability of islets to stabilize blood glucose levels and prevent severe hypoglycemia in a selected group of subjects with Type 1 diabetes. The main limitations of islet transplantation are the need for systemic immunosuppression to maintain function and the loss of islet function over time. Additionally, many studies have demonstrated that the current site of transplantation in the liver is not an ideal site due to several factors. These factors include (1) significant liver inflammation following islet infusion; (2) potential for life-threatening procedure-related complications such as bleeding and thrombosis; (3) high levels of immunosuppressive drugs and GI toxins in the liver contributing to islet toxicity; (4) the inability to retrieve islets after infusion; and (5) development of graft dysfunction in a number of recipients of intrahepatic allogeneic and autologous islets. The implantation of islets into the omentum will allow adequate engraftment of islets onto the omentum and will lead to comparable or superior functional and clinical outcomes than in the traditional intrahepatic site.
Study Details
Timeline
Interventions
Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.