CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3 enrolled
Drug / intervention
Islet transplantationbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02213003
NCT02213003Phase 2Completed

Allogeneic Islet Cells Transplanted Onto the Omentum

Rodolfo Alejandro·interventional·Posted Aug 11, 2014·Updated Aug 12, 2025

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 11, 2014
Enrollment StartSep 1, 2014
Primary CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 11.9 years ago

Interventions

Islet transplantationbiological

Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.