The University of California San Diego and its commercial medical tech company called Ventrix, has successfully conducted a first-in-human,US FDA-approved Phase 1 clinical trial of an injectable hydrogel that repairs damaged heart tissue and restore cardiac function in heart failure patients who previously suffered a heart attack. The hydrogel is a revolutionary material that is capable of repairing heart tissues in a very short phase of time and even enhance the tissues and surrounding blood capillaries, arteries and veins.
Prof Karen Christman,at UC San Diego, led the development of Ventrigel, a hydrogel
to repair heart tissue after heart attacks. Credit: David Baillot/University of California San Diego
The clinical trial is the first to test a hydrogel designed to repair cardiac tissue. It is also the first to test a hydrogel made from the natural scaffolding of cardiac muscle tissue, also known as ECM or extracellular matrix. This is important because ECM hydrogels have been shown in preclinical studies to potentially be effective for other conditions, such as poor blood circulation due to peripheral artery disease. The trial showed that the hydrogel, known as VentriGel, can be safely injected via catheter into patients who had suffered a heart attack in the past 1 to 36 months.
Professor Karen Christman, lead researcher from the Institute of Engineering in Medicine at UC San Diego commented in a phone interview with Thailand Medical News. "Although the study was designed to evaluate safety and feasibility and not designed to show whether VentriGel effectively helps improve heart function, we observed some improvements in patients.For example, patients could walk longer distances. We also observed signs of improving heart function in patients who experienced a heart attack more than one year prior to treatment."
Each year, there are an estimated 872,000 new heart attack cases in America with no established treatment for repairing the resulting damage to cardiac tissue. After a heart attack, scar tissue develops, which diminishes muscle function and leads to heart failure. This is where VentriGel comes in. Once injected in damaged cardiac muscle, VentriGel forms a scaffold that acts as a reparative environment where healthy cells migrate, leading to increases in cardiac muscle, less scar tissue, and improvements in heart function.
Dr. Jay Traverse at Minneapolis Heart Institute was the lead clinical investigator VentriGel was invented by Christman and her team, then licensed from UC San Diego and developed by Ventrix, Inc, which was cofounded by CEO Adam Kinsey and Christman.
Tissue from the skeletal muscle of pigs is spun in detergent until only the fibrous
extracellular matrix remains. Credit: David Baillot/University of California San Diego
VentriGel is made from cardiac connective tissue taken from pigs, which is stripped of heart muscle cells through a cleansing process. It is then freeze-dried and milled into powder form, and then liquefied into a fluid that can be easily injected into heart muscle in a minimally invasive procedure that does no
t require surgery. Once it hits body temperature, the liquid turns into a semi-solid, porous gel.
The Phase 1 trial evaluated the gel in 15 patients who suffered moderate damage in the left ventricle chamber of the heart following a heart attack. Each patient received up to 20 injections of VentriGel into the damaged region via catheter. Researchers followed the patients for six months after treatment. All patients completed the full follow-up. Twelve of the 15 patients were males. All 15 were experiencing mild to moderate heart failure following a heart attack. Half had suffered a heart attack within the past year.
Patients took a six-minute walking test as well as a heart function assessment and a heart health questionnaire before the injections. They retook the tests three and six months later. In addition, patients underwent an MRI at three and six months after the procedures.
Ventrix is preparing up for a Phase 2 clinical trial that will expand on this successful first-in-human study and is expected to start in November 2019. The team is planning a more extensive and larger, randomized trial that will evaluate how effectively VentriGel can improve cardiac function and quality of life for patients experiencing heart failure. Commercialization of Ventrigel is expected to start as early as the end of 2020 with the US FDA expecting to fast track approvals due to a variety of reasons.
Reference: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. First-in-Man Study of a Cardiac Extracellular Matrix Hydrogel in Early and Late Myocardial Infarction Patients. JACC: Basic to Translational Science, 2019; DOI: 10.1016/j.jacbts.2019.07.012