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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 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.

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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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2012-04
Est. Completion 2013-08
Phase Phase 2

Sponsor

Deborah Ascheim

1 total trials

What the Registry Record Tells You About NCT01442129

The ClinicalTrials.gov registry entry for NCT01442129 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The listed sponsor is Deborah Ascheim, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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