First-in-Man Study of a Cardiac Extracellular Matrix Hydrogel in Early and Late Myocardial Infarction Patients

Jay H. Traverse, MD; Timothy D. Henry, MD; Nabil Dib, MD; Amit N. Patel, MD; Carl Pepine; Gary L. Schaer, MD; Jessica A. DeQuach, PhD; Adam M. Kinsey, PhD; Paul Chamberlin, MD; Karen L. Christman, PhD

JACC: Basic to Translational Science (Oct 2019)

First-in-Man Study of a Cardiac Extracellular Matrix Hydrogel in Early and Late Myocardial Infarction Patients

Jay H. Traverse, MD,
Timothy D. Henry, MD,
Nabil Dib, MD,
Amit N. Patel, MD,
Carl Pepine,
Gary L. Schaer, MD,
Jessica A. DeQuach, PhD,
Adam M. Kinsey, PhD,
Paul Chamberlin, MD,
Karen L. Christman, PhD

Affiliations

Jay H. Traverse, MD: Minneapolis Heart Institute, Minneapolis, Minnesota; Dr. Jay H. Traverse, Minneapolis Heart Institute, 920 East 28th Street, Suite 300, Minneapolis, Minnesota 55407.
Timothy D. Henry, MD: The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio
Nabil Dib, MD: Dignity Health Mercy Gilbert Medical Center, Gilbert, Arizona
Amit N. Patel, MD: Dewitt Daughtry Family Department of Surgery, Division of Cardiothoracic Surgery, University of Miami, Leonard M. Miller School of Medicine, Miami, Florida
Carl Pepine: University of Florida College of Medicine, Gainesville, Florida
Gary L. Schaer, MD: Division of Cardiology, Rush University Medical Center, Chicago, Illinois
Jessica A. DeQuach, PhD: Ventrix, Inc., San Diego, California
Adam M. Kinsey, PhD: Ventrix, Inc., San Diego, California
Paul Chamberlin, MD: Ventrix, Inc., San Diego, California
Karen L. Christman, PhD: Department of Bioengineering, Sanford Consortium for Regenerative Medicine, La Jolla, California; Address for correspondence: Dr. Karen L. Christman, Department of Bioengineering, Sanford Consortium for Regenerative Medicine, 2880 Torrey Pines Scenic Drive, La Jolla, California 92037.

Journal volume & issue: Vol. 4, no. 6
pp. 659 – 669

Abstract

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Summary: This study evaluated the safety and feasibility of transendocardial injections of VentriGel, a cardiac extracellular matrix hydrogel, in early and late post–myocardial infarction (MI) patients with left ventricular (LV) dysfunction. VentriGel was delivered in 15 patients with moderate LV dysfunction (25% ≤ LV ejection fraction ≤ 45%) who were between 60 days to 3 years post-MI and were revascularized by percutaneous coronary intervention. The primary endpoints were incidence of adverse events and abnormal clinical laboratory results. This first-in-man study established the safety and feasibility of delivering VentriGel in post-MI patients, thus warranting further evaluation in larger, randomized clinical trials. Key Words: biomaterial, catheter, heart failure, injectable, myocardial infarction

Published in JACC: Basic to Translational Science

ISSN: 2452-302X (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Specialties of internal medicine: Diseases of the circulatory (Cardiovascular) system
Website: https://www.journals.elsevier.com/jacc-basic-to-translational-science/

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