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

Amish N. Raval, Thomas D. Cook, Henricus J. Duckers, Peter V Johnston, Jay H. Traverse, William T. Abraham, Peter A. Altman, Carl J. Pepine

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)141-148
Number of pages8
JournalAmerican Heart Journal
Volume201
DOIs
Publication statusPublished - Jul 1 2018

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ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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