Source: University of
California - San Diego
Summary:
Scientists successfully conducted a first-in-human, FDA-approved Phase 1
clinical trial of an injectable hydrogel that aims to repair damage and restore
cardiac function in heart failure patients who previously suffered a heart
attack. The 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.
Ventrix,
a University of California San Diego spin-off company, has successfully
conducted a first-in-human, FDA-approved Phase 1 clinical trial of an
injectable hydrogel that aims to repair damage and restore cardiac function in
heart failure patients who previously suffered a heart attack.
The
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 extracellular matrix, or ECM. This is significant
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 2 to 36 months.
"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," said Karen Christman, the paper's senior
author and a professor of bioengineering in the Jacobs School of Engineering
and the Institute of Engineering in Medicine at UC San Diego. "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."
Researchers
from Ventrix, led by Christman, report their findings in the Sept. 11 issue of
the Journal of the American College of Cardiology: Basic to Translational
Science. Dr. Jay Traverse at Minneapolis Heart Institute was the lead clinical
investigator.
There
are an estimated 785,000 new heart attack cases in the United States each year,
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.
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.
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 not
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 sustained moderate damage in
the left ventricle chamber of the heart following a heart attack. Each patient
received up to 18 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 men. 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 now gearing up for a Phase 2 clinical trial that will expand on this
successful first-in-human study. They are planning a larger, randomized trial
that will evaluate how effectively VentriGel can improve cardiac function and
quality of life for patients experiencing heart failure.
Source:
https://www.sciencedaily.com/releases/2019/09/190911142821.htm
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