NCT02362646

Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Annetine Gelijns · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Intramyocardial injection of mesenchymal precursor cells (MPC) in patients with advanced heart failure who are treated with left ventricular assist device (LVAD) implantation may result in a renewable source of proliferating functional cardiomyocytes; induce development of capillaries and larger-size blood vessels to supply oxygen and nutrients to endogenous myocardium and newly-implanted cardiomyocytes; and release factors capable of paracrine signaling.

Conditions

• Heart Failure
• Cardiomyopathy
• Ventricular Dysfunction

Interventions

Type	Name	Description
BIOLOGICAL	MPC Intramyocardial Injection	Intramyocardial injection of 150 million mesenchymal precursor cells at the time of LVAD implantation
DRUG	Control Solution

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-08-10
• Completion: 2019-08-23
• First posted: 2015-02-13
• Last updated: 2019-11-26
• Results posted: 2019-11-26

Locations

19 sites across 2 countries: United States, Canada