drugset / Trial / NCT02213003

Allogeneic Islet Cells Transplanted Onto the Omentum

NCT02213003 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-09
Primary completion
2024-06-30
Completion
2024-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Allogeneic Islet Cells Cell therapy 5000 unknown Other