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NCT01442129 · ClinicalTrials.gov registry record · Phase 2
The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation
A Phase 2 study of Heart Failure and Cardiomyopathy, sponsored by Deborah Ascheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 11
- Study locations
NCT01442129: Completed Phase 2 study of Heart Failure and Cardiomyopathy, sponsored by Deborah Ascheim.
NCT01442129 is a Phase 2 study of Heart Failure and Cardiomyopathy that has completed, run by Deborah Ascheim. The registered enrollment target is 30 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01442129, a Phase 2 study of Heart Failure and Cardiomyopathy, has completed, sponsored by Deborah Ascheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 11
- Study locations
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
The primary safety endpoint of this study is the incidence of the following potential study-intervention related adverse events within 90 days post intervention (LVAD implantation + intramyocardial injection of study product): infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization.
Conditions Studied
Interventions
- BIOLOGICAL MPC Intramyocardial injection
- BIOLOGICAL Control Solution
Study Locations (11)
New York
- Columbia University Medical Center - New York
- Montefiore Einstein Heart Center - The Bronx
Ohio
- Cleveland Clinic Foundation - Cleveland
- Ohio State University - Columbus
Texas
- Baylor Research Institute - Dallas
- Texas Heart Institute - Houston
Florida
- University of Florida - Gainsville
Maryland
- University of Maryland - Baltimore
Minnesota
- Minneapolis Heart Institute Foundation - Minneapolis
North Carolina
- Duke University - Durham
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT01442129 record still lists
NCT01442129 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 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which MPC Intramyocardial injection is the first listed.
NCT01442129 lists 11 locations in 8 states (New York, Ohio, Texas).
Frequently Asked Questions
What is clinical trial NCT01442129 about?
NCT01442129 is a clinical study titled "The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation". 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 ves...
What is the current status of trial NCT01442129?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2012-04. Estimated completion is 2013-08.
What conditions does trial NCT01442129 study?
This clinical trial studies the following conditions: Heart Failure, Cardiomyopathy, Ventricular Dysfunction.
What interventions are being tested in trial NCT01442129?
The interventions under investigation include: MPC Intramyocardial injection (BIOLOGICAL), Control Solution (BIOLOGICAL).
Who is sponsoring clinical trial NCT01442129?
This trial is sponsored by Deborah Ascheim, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01442129 being conducted?
This trial has 11 study locations across Florida, Maryland, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01442129's enrollment target sits among peer trials
30 322nd of 397 higher than 69 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure 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.
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