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NCT02447926 · ClinicalTrials.gov registry record · NA
Procurement of Leukapheresis Products From End Stage Liver Disease (ESLD) Patients for Immunological Studies
A NA study, sponsored by Northwestern University.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT02447926 is a NA study that was terminated before completion, run by Northwestern University. The registered enrollment target is 1 participants.
The verdict
NCT02447926, a NA study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or periphery can control immune responsiveness to auto- and allo-antigens. However, there have been few efforts to harness the therapeutic potential of isolated Tregs to control graft rejection and inducing transplantation tolerance in solid organ recipients. In order for Tregs to be used as a clinical treatment, the following properties are necessary: ex vivo generation of sufficient numbers of cells, migration in vivo to sites of antigenic reactivity, ability to suppress rejection in an alloantigen-specific manner, and survival/expansion after infusion. The and others have demonstrated 1) the feasibility of expanding Treg ex vivo, 2) the ability of these cells to down-regulate allogeneic immune responses in vitro, and 3) the efficacy of Treg for prevention of allograft rejection in animal models. In kidney transplant, the investigators have developed strategies for the ex vivo expansion of naturally occurring human Tregs (nTregs) from leukapheresis products that would allow for the clinical employment of this cellular therapy. The investigators are also interested in this approach in patients with end stage liver disease (ESLD) undergoing liver transplantation (LT). Our central hypothesis is that alloreactive human nTreg with suppressive action can be expanded ex vivo from ESLD patients (this proposal) and used to both prevent liver transplant rejection and facilitate the minimization and withdrawal of drug-based immunosuppression (future proposals). This application will further define and validate efficient methods for ex vivo expansion of human CD4+CD25+CD127- FOXP3+nTregs cells in ESLD. The investigators herein propose to use leukapheresis products obtained from patients with ESLD to further refine and optimize protocols for expansion of Tregs. Suppressive function of expanded cells will be assessed using in vitro assays of alloreactivity (mixed lymphocyte culture).
Interventions
- PROCEDURE Leukapheresis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02447926
The ClinicalTrials.gov registry entry for NCT02447926 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Leukapheresis is the first listed.
NCT02447926 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02447926 about?
NCT02447926 is a clinical study titled "Procurement of Leukapheresis Products From End Stage Liver Disease (ESLD) Patients for Immunological Studies". Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or periphery can control immune responsiveness to auto- and allo-antigens. However, there have been few efforts to harness the therapeutic potential of isolated Tregs to control graft rejection and inducing transplantation tolerance in ...
What is the current status of trial NCT02447926?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2014-07. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02447926?
The interventions under investigation include: Leukapheresis (PROCEDURE).
Who is sponsoring clinical trial NCT02447926?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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