Author + information
- Received June 20, 2019
- Revision received July 26, 2019
- Accepted July 27, 2019
- Published online October 28, 2019.
- Jay H. Traverse, MDa,∗∗ (, )
- Timothy D. Henry, MDb,
- Nabil Dib, MDc,
- Amit N. Patel, MDd,
- Carl Pepinee,
- Gary L. Schaer, MDf,
- Jessica A. DeQuach, PhDg,
- Adam M. Kinsey, PhDg,
- Paul Chamberlin, MDg and
- Karen L. Christman, PhDh,∗ ()
- aMinneapolis Heart Institute, Minneapolis, Minnesota
- bThe Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio
- cDignity Health Mercy Gilbert Medical Center, Gilbert, Arizona
- dDewitt Daughtry Family Department of Surgery, Division of Cardiothoracic Surgery, University of Miami, Leonard M. Miller School of Medicine, Miami, Florida
- eUniversity of Florida College of Medicine, Gainesville, Florida
- fDivision of Cardiology, Rush University Medical Center, Chicago, Illinois
- gVentrix, Inc., San Diego, California
- hDepartment 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.
- ↵∗∗Dr. Jay H. Traverse, Minneapolis Heart Institute, 920 East 28th Street, Suite 300, Minneapolis, Minnesota 55407.
• 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.
This study was supported by Ventrix, Inc., San Diego, California. Drs. Kinsey and Christman and KLC are cofounders of Ventrix, Inc.; Drs. DeQuach, Chamberlin, and Christman are consultants and receive income from Ventrix, Inc.; Drs. Kinsey and Christman are board members of Ventrix, Inc.; Dr. Kinsey is an employee of Ventrix, Inc.; Drs. Dib, DeQuach, Kinsey, and Chamberlin hold equity interest in Ventrix, Inc. Dr. Dib is owner of Tri LLC and UltraNav Medical LLC; and a consultant for BDS and CSI. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Basic to Translational Science author instructions page.
- Received June 20, 2019.
- Revision received July 26, 2019.
- Accepted July 27, 2019.
- 2019 The Authors