At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 30 enrolled

Drug / intervention

MPC Intramyocardial injection +1 morebiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01442129

NCT01442129Phase 2Completed

Compare CT.gov

LVAD Therapy: Exploring the Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function

Deborah Ascheim·interventional·Posted Sep 28, 2011·Updated May 1, 2015

In Brief

A Phase 2 clinical trial evaluating MPC Intramyocardial injection and Control Solution for Heart Failure and 2 related conditions. Completed, enrolled 30 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHeart Failure, Cardiomyopathy, Ventricular Dysfunction

CountriesUnited States

CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished

201220132014201520162017201820192020202120222023202420252026

First PostedSep 2011

Enrollment StartApr 2012

Primary CompletionMar 2013

Study CompletionAug 2013

TodayJul 2026

First PostedSep 28, 2011

Enrollment StartApr 1, 2012

Primary CompletionMar 1, 2013

Study CompletionAug 1, 2013

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 14.8 years ago

Interventions

MPC Intramyocardial injectionbiological

Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation

Control Solutionbiological

Injection of control solution during the LVAD implantation.