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NCT02846883 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms
A Phase 1 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02846883: Clinical Trial Phase 1 study, sponsored by VA Office of Research and Development.
NCT02846883 is a Phase 1 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02846883, a Phase 1 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This project is to determine the safety and explore the effectiveness of allogeneic (not cells of the participant but those of another human) mesenchymal stromal cells (MSCs) in decreasing inflammation and possible enlargement of the participants' abdominal aortic aneurysm. Participants will be selected as a possible subject because of an abdominal aortic aneurysm discovered on the ultrasound or computed tomographic ("CT") scan requested by the participants' doctor. The purpose of this study is to collect information that will be used to determine if MSCs can be used to decrease inflammation and possibly slow down enlargement of the participants' aneurysm. The investigators will also be collecting blood samples to study special inflammatory cells that cause aneurysms as well as asking participants to have a "PET" (positron emission tomography) scan that can measure inflammation directly in the participants' aneurysm.
Primary Outcome
This trial will test the hypothesis that MSCs, in a dose dependent fashion (1 x 10\^6 MSC/kg vs 3 x 10\^6 MSC/kg) promote the frequency and immune suppressor function of Treg cells as measured by mass cytometry compared to baseline.
Interventions
- DRUG Placebo
- BIOLOGICAL 1 million MSCs/kg
- BIOLOGICAL 3 million MSCs/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2016-12-05 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 1 |
Why NCT02846883 stopped before completion
NCT02846883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02846883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02846883 about?
NCT02846883 is a clinical study titled "Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms". This project is to determine the safety and explore the effectiveness of allogeneic (not cells of the participant but those of another human) mesenchymal stromal cells (MSCs) in decreasing inflammation and possible enlargement of the participants' abdominal aortic aneurysm. Participants will be sele...
What is the current status of trial NCT02846883?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2016-12-05. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT02846883?
The interventions under investigation include: Placebo (DRUG), 1 million MSCs/kg (BIOLOGICAL), 3 million MSCs/kg (BIOLOGICAL).
Who is sponsoring clinical trial NCT02846883?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02846883's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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