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

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

doi:10.1016/j.jacbts.2019.07.012

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

JACC Basic Transl Sci. 2019 Sep 11;4(6):659-669. doi: 10.1016/j.jacbts.2019.07.012. eCollection 2019 Oct.

Authors

Affiliations

¹ Minneapolis Heart Institute, Minneapolis, Minnesota.
² The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio.
³ Dignity Health Mercy Gilbert Medical Center, Gilbert, Arizona.
⁴ Dewitt Daughtry Family Department of Surgery, Division of Cardiothoracic Surgery, University of Miami, Leonard M. Miller School of Medicine, Miami, Florida.
⁵ University of Florida College of Medicine, Gainesville, Florida.
⁶ Division of Cardiology, Rush University Medical Center, Chicago, Illinois.
⁷ Ventrix, Inc., San Diego, California.
⁸ Department of Bioengineering, Sanford Consortium for Regenerative Medicine, La Jolla, California.

Abstract

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.

Keywords: BNP, B-type natriuretic peptide; CMR, cardiac magnetic resonance; ECM, extracellular matrix; EF, ejection fraction; LV, left ventricular; LVEDV, left ventricular end-diastolic volume; LVESV, left ventricular end-systolic volume; MI, myocardial infarction; MLWHFQ, Minnesota Living with Heart Failure Questionnaire; NYHA, New York Heart Association; biomaterial; catheter; heart failure; injectable; myocardial infarction.