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NCT02213003 · ClinicalTrials.gov registry record · Phase 1
Allogeneic Islet Cells Transplanted Onto the Omentum
A Phase 1 study, sponsored by Rodolfo Alejandro.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT02213003 is a Phase 1 study that has completed, run by Rodolfo Alejandro. The registered enrollment target is 3 participants.
The verdict
NCT02213003, a Phase 1 study, has completed, sponsored by Rodolfo Alejandro.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Islet transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-09 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02213003
The ClinicalTrials.gov registry entry for NCT02213003 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rodolfo Alejandro, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Islet transplantation is the first listed.
NCT02213003 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02213003 about?
NCT02213003 is a clinical study titled "Allogeneic Islet Cells Transplanted Onto the Omentum". 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 immun...
What is the current status of trial NCT02213003?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2014-09. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT02213003?
The interventions under investigation include: Islet transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT02213003?
This trial is sponsored by Rodolfo Alejandro, which has 10 total clinical trials registered on ClinicalTrials.gov.
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