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

[Display omitted] •A first-in-man clinical trial was completed with VentriGel, an extracellular matrix hydrogel derived from decellularized porcine myocardium, in post–MI patients.•Results from the trial support the safety and feasibility of transendocardial injection of VentriGel in post–MI patient...

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Published in:JACC. Basic to translational science Vol. 4; no. 6; pp. 659 - 669
Main Authors: Traverse, Jay H., Henry, Timothy D., Dib, Nabil, Patel, Amit N., Pepine, Carl, Schaer, Gary L., DeQuach, Jessica A., Kinsey, Adam M., Chamberlin, Paul, Christman, Karen L.
Format: Journal Article
Language:English
Published: Elsevier Inc 01.10.2019
Elsevier
Subjects:
biomaterial
Cardiovascular
catheter
CLINICAL RESEARCH
heart failure
injectable
myocardial infarction
NYHA
heart failure
EF
catheter
biomaterial
BNP
myocardial infarction
MLWHFQ
CMR
LVESV
LV
ECM
injectable
LVEDV
MI
Minnesota Living with Heart Failure Questionnaire
ejection fraction
New York Heart Association
B-type natriuretic peptide
left ventricular end-diastolic volume
left ventricular
cardiac magnetic resonance
left ventricular end-systolic volume
extracellular matrix
ISSN:2452-302X, 2452-302X
Online Access:Get full text
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Summary:[Display omitted] •A first-in-man clinical trial was completed with VentriGel, an extracellular matrix hydrogel derived from decellularized porcine myocardium, in post–MI patients.•Results from the trial support the safety and feasibility of transendocardial injection of VentriGel in post–MI patients with left ventricular dysfunction.•Although the study was not designed to evaluate efficacy, there were suggestions of improvements including increases in 6-min walk test distance and decreases in New York Heart Association functional class across the entire cohort of patients.•Improvements in left ventricular remodeling were mainly observed in patients who were treated >1-year post–MI as opposed to <1 year.•Results from the trial warrant further evaluation in larger randomized, controlled clinical trials. 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.
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ISSN:2452-302X
2452-302X
DOI:10.1016/j.jacbts.2019.07.012