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Am Heart J. 2018 Jul;201:141-148. doi: 10.1016/j.ahj.2018.03.016. Epub 2018 Apr 3.

The CardiAMP Heart Failure trial: A randomized controlled pivotal trial of high-dose autologous bone marrow mononuclear cells using the CardiAMP cell therapy system in patients with post-myocardial infarction heart failure: Trial rationale and study design.

Author information

1
Division of Cardiovascular Medicine, Department of Medicine and Biomedical Engineering, University of Wisconsin School of Medicine and Public Health, Madison, WI. Electronic address: anr@medicine.wisc.edu.
2
Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, WI.
3
Biocardia Inc., San Carlos, CA.
4
Division of Cardiovascular Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.
5
Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN.
6
Departments of Medicine, Physiology, and Cell Biology, Division of Cardiovascular Medicine, and the Davis Heart and Lung Research Institute, The Ohio State University, Columbus, OH.
7
Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL.

Abstract

BACKGROUND:

Heart failure following myocardial infarction is a common, disabling, and deadly condition. Direct injection of autologous bone marrow mononuclear cells into the myocardium may result in improved functional recovery, relieve symptoms, and improve other cardiovascular outcomes.

METHODS:

CardiAMP-HF is a randomized, double-blind, sham-controlled, pivotal trial designed to investigate the safety and efficacy of autologous bone marrow mononuclear cells treatment for patients with medically refractory and symptomatic ischemic cardiomyopathy. The primary end point is change in 6-minute walk distance adjusted for major adverse cardiovascular events at 12 months following treatment. Particularly novel aspects of this trial include a cell potency assay to screen subjects who have bone marrow cell characteristics that suggest a favorable response to treatment, a point-of-care treatment method, a high target dose of 200 million cells, and an efficient transcatheter intramyocardial delivery method that is associated with high cell retention.

CONCLUSIONS:

This novel approach may lead to a new treatment for those with ischemic heart disease suffering from medically refractory heart failure.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02438306.

PMID:
29803986
DOI:
10.1016/j.ahj.2018.03.016
[Indexed for MEDLINE]

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