NCT02213003|CompletedPhase 1/2ResultsDMCFDA Drug
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Sponsor study identifier
interventional
3
1 country
1
Study Start
September 2014
Actual (reported)Primary Completion
June 30, 2024
Actual (reported)Study Completion
June 30, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 7, 2014
Actual (reported)August 11, 2014
Actual (reported)September 2014
Actual (reported)June 30, 2024
Actual (reported)June 30, 2024
Actual (reported)August 12, 2025
Actual (reported)A1c </= 6.5% and no Severe Hypoglycemia
Composite outcome measured by the proportion of subjects with HbA1c level of \</= 6.5 % and free of severe hypoglycemic events after omentum islet transplant
From day 28 to day 365 after omentum islet transplant
Procedural Complications
Safety outcome. Post-procedural complications included were: Bleeding, wound infection, hernia, torsion of omentum, gastrointestinal obstruction, abscess, cysts, and need for surgical intervention. Measured by the count of participants with procedural complications.
From day 28 to day 365 after omentum islet transplant
Transplantation of at least 5000 islet equivalents/kg of body weight onto the omentum.
Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Rodolfo Alejandro
University of Miami
3 participants (actual enrollment reported by the registry).
First Submitted
August 7, 2014
First Posted
August 11, 2014
Study Start
September 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 30, 2024
Actual (reported)Study Completion
June 30, 2024
Actual (reported)Last Updated
August 12, 2025
Results First Posted
August 12, 2025
Record last verified: 2025-07
undecided. This is a small phase 1/2 pilot trial.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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