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NCT02013674 · ClinicalTrials.gov registry record · Phase 2
The TRansendocardial Stem Cell Injection Delivery Effects on Neomyogenesis STudy (The TRIDENT Study)
A Phase 2 study, sponsored by Joshua M Hare.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT02013674: Completed Phase 2 study, sponsored by Joshua M Hare.
NCT02013674 is a Phase 2 study that has completed, run by Joshua M Hare. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02013674, a Phase 2 study, has completed, sponsored by Joshua M Hare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI scheduled to undergo cardiac catheterization will be enrolled in the study. This is a phase II study intended to gain additional safety and efficacy assessments among two dose levels previously studied in a phase I setting.
Primary Outcome
Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events, defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise).
Interventions
- BIOLOGICAL Allogeneic hMSCs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-02-13 |
| Est. Completion | 2017-09-18 |
| Phase | Phase 2 |
What the finished NCT02013674 record still lists
NCT02013674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Allogeneic hMSCs is the first listed.
NCT02013674 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02013674 about?
NCT02013674 is a clinical study titled "The TRansendocardial Stem Cell Injection Delivery Effects on Neomyogenesis STudy (The TRIDENT Study)". Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI scheduled to undergo cardiac catheterization will be enrolled in the study. This is a phase II study intended to gain additional safety and efficacy assessments among two dose levels previously studied in a phase...
What is the current status of trial NCT02013674?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2014-02-13. Estimated completion is 2017-09-18.
What interventions are being tested in trial NCT02013674?
The interventions under investigation include: Allogeneic hMSCs (BIOLOGICAL).
Who is sponsoring clinical trial NCT02013674?
This trial is sponsored by Joshua M Hare, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02013674's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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