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NCT02362646 · ClinicalTrials.gov registry record · Phase 2
Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
A Phase 2 study, sponsored by Annetine Gelijns.
- Completed
- Registry status
- Phase 2
- Development phase
- 159
- Enrollment target
NCT02362646: Completed Phase 2 study, sponsored by Annetine Gelijns.
NCT02362646 is a Phase 2 study that has completed, run by Annetine Gelijns. The registered enrollment target is 159 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02362646, a Phase 2 study, has completed, sponsored by Annetine Gelijns.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 159 participants
- Enrollment target
Study Summary
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.
Primary Outcome
functional status, defined by the number of temporary weans from LVAD support tolerated over the 6 months post-randomization. A successful wean is the ability to tolerate temporary weaning from LVAD support for 30 minutes without sustained symptoms of worsening heart failure. Wean failures are defined as inability to tolerate the temporary wean for 30 minutes; death; or patient too unstable, in the judgment of the primary heart failure cardiologist, to tolerate the wean attempt.
Interventions
- BIOLOGICAL MPC Intramyocardial Injection
- DRUG Control Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2015-07 |
| Est. Completion | 2019-08-23 |
| Phase | Phase 2 |
What the finished NCT02362646 record still lists
NCT02362646 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which MPC Intramyocardial Injection is the first listed.
NCT02362646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02362646 about?
NCT02362646 is a clinical study titled "Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients". The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vess...
What is the current status of trial NCT02362646?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2015-07. Estimated completion is 2019-08-23.
What interventions are being tested in trial NCT02362646?
The interventions under investigation include: MPC Intramyocardial Injection (BIOLOGICAL), Control Solution (DRUG).
Who is sponsoring clinical trial NCT02362646?
This trial is sponsored by Annetine Gelijns, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02362646's enrollment target sits among peer trials
159 442nd of 2000 higher than 1,558 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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