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NCT02145325 · ClinicalTrials.gov registry record · Phase 1
Trial of Adoptive Immunotherapy With TRACT to Prevent Rejection in Living Donor Kidney Transplant Recipients
A Phase 1 study of End Stage Renal Disease, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02145325 is a Phase 1 study of End Stage Renal Disease that has completed, run by Northwestern University. The registered enrollment target is 10 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02145325, a Phase 1 study of End Stage Renal Disease, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or peripheral tissues have been demonstrated to broadly control T cell reactivity (14). Importantly, Tregs have been shown to control immune responsiveness to alloantigens and significantly contribute to operational tolerance in transplantation models (15, 16). However, there have been limited efforts to harness the therapeutic potential of directly isolated CD4+CD25+ Treg cells for controlling graft rejection and inducing transplantation tolerance, such as for kidney transplants. In order for CD4+CD25+ Treg cells to be used as a clinical treatment, the following cell properties could be 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 for a critical, but currently unknown, period of time. Our published work and that of other investigators has demonstrated 1) the feasibility of expanding Treg ex vivo, 2) the ability of these cells to downregulate allogeneic immune responses in vitro, and 3) the efficacy of Treg for prevention of allograft rejection in animal models (15,16). We have developed strategies for the ex vivo expansion of naturally occurring human Tregs (nTregs) that allow for the practical employment of this cellular therapy in the clinic. Our central hypothesis is that sufficient human nTreg can be expanded ex vivo and used to both prevent renal transplant rejection and facilitate the reduction and subsequent withdrawal of drug-based immunosuppression. This study will allow for us to define the safety of Treg adoptive cellular transfer (TRACT) in living donor renal transplant recipients that draws upon our extensive preclinical experience with expanded Tregs, as well as our recognized clinical expertise with designing immunosuppressive regimens compatible with this type of therapeutic cell transfer.
Conditions Studied
Interventions
- DRUG Expanded Tregs
Study Locations (1)
Illinois
- Northwestern University Comprehensive Transplant Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-06-16 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02145325
The ClinicalTrials.gov registry entry for NCT02145325 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (99% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with End Stage Renal Disease appearing as the primary indexed condition, and to 1 intervention - of which Expanded Tregs is the first listed.
NCT02145325 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT02145325 about?
NCT02145325 is a clinical study titled "Trial of Adoptive Immunotherapy With TRACT to Prevent Rejection in Living Donor Kidney Transplant Recipients". Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or peripheral tissues have been demonstrated to broadly control T cell reactivity (14). Importantly, Tregs have been shown to control immune responsiveness to alloantigens and significantly contribute to operational tolerance in transpl...
What is the current status of trial NCT02145325?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2014-04. Estimated completion is 2016-06-16.
What conditions does trial NCT02145325 study?
This clinical trial studies the following conditions: End Stage Renal Disease.
What interventions are being tested in trial NCT02145325?
The interventions under investigation include: Expanded Tregs (DRUG).
Who is sponsoring clinical trial NCT02145325?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02145325 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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