A spin-off company of the University of California called Ventrix recently conducted its first in-human clinical trial. They organized an FDA approved Phase 1 clinical trial for an injectable hydrogel that is specifically designed to help repair damages to the heart and to hopefully restore full cardiac functions. The trial is the first of its kind as it focuses on repairing cardiac tissue using an all-natural scaffolding of muscle tissues in the heart known as the ECM.
Extracellular matrix or the ECM and the approval of its use has become significant considering the potential that the ECM hydrogels show during its preclinical studies. The trial shows that Ventrigel (as it has become known for) can be safety injected via catheter into patients who have suffered from a major heart attack in the last two to thirty six months.
"The safety and feasibility of Ventrigel were the primary concern of the study particularly on how it can help improve the overall heart function. However, clear manifestations of improvement can be seen in the study," said Karen Christman. She is a bioengineering professor from the Jacobs School of Engineering and the Institute of Engineering in Medicine at UC San Diego and served as the primary author of the study.
"For instance, patients who received the medication could now walk in longer distances. Noticeable improvements also show in the signs of a heart function, particularly those who have suffered from a heart attack not more than a year before the treatment was given."
Christman along with the other researchers for Ventrix have reported their findings in the most recent issue of the Journal of the American College of Cardiology: Basic to Translational Science. The lead clinical investigator of the study is Dr. Jay Traverse from the Minneapolis Heart Institute.
From the heart attack, the patient develops scar tissues that cause the function of the muscles to diminish. This, eventually, leads to heart failure. VentriGel, once injected will form a scaffold on the damaged cardiac model that will act as the reparative environment. The healthy cells will then migrate to hopefully form stronger cardiac muscles. This then leads to fewer scar tissues translated into more visible improvements in the heart function.
VentriGel is made up for cardiac connective tissues taken from swine, which then undergoes a cleaning process that stips off its heart muscle cells. The Phase 1 of the trial evaluated the effect of the gel among 15 registered patients who all suffered moderate damage on the left ventricle of their hearts.
The study is now preparing for Phase 2 of the clinical trial to hopefully expand its study on humans.
