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NCT02088931 · ClinicalTrials.gov registry record · Phase 1
Treg Adoptive Therapy for Subclinical Inflammation in Kidney Transplantation
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT02088931: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT02088931 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02088931, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety of the experimental therapy of a single infusion of Regulatory T cells (Tregs). The investigators want to find out what effects, good or bad, Tregs will have on the kidney transplant patients. There are different types of T cells. This study uses Regulatory T cells (Tregs), which are found in the blood and are part of the immune system that stops other immune cells from working. Tregs help to turn off the immune system after other immune cells have finished tackling outside infections, and Tregs keep the immune system in check so that the body does not attack itself. The researchers are hoping that, by giving an infusion of Tregs that the attack on the kidney can be stopped and kidney function will be stabilized. It is not known if the Treg experimental therapy can stop the inflammation in the kidney. In this study, the researchers will take some of Tregs from the patient, multiply them in the laboratory, and then infuse them back into the patient. The procedure used to multiply Tregs is an experimental process performed in the laboratory. Similar procedures done with mice have been shown to reverse inflammation but it is not known whether the results will be the same in humans. This therapy has not yet been done in humans outside of a research study.
Primary Outcome
Participants will be assessed for adverse events on days 0-1 (Treg infusion) and on days 4,7,14,21,28,84,180, and 360 (1 year).
Interventions
- BIOLOGICAL Treg infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 1 |
What the finished NCT02088931 record still lists
NCT02088931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Treg infusion is the first listed.
NCT02088931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02088931 about?
NCT02088931 is a clinical study titled "Treg Adoptive Therapy for Subclinical Inflammation in Kidney Transplantation". The purpose of this study is to test the safety of the experimental therapy of a single infusion of Regulatory T cells (Tregs). The investigators want to find out what effects, good or bad, Tregs will have on the kidney transplant patients. There are different types of T cells. This study uses Regu...
What is the current status of trial NCT02088931?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2014-03. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT02088931?
The interventions under investigation include: Treg infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT02088931?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02088931's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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