Science 3 min read

Clinical Trial Proves Hydrogel Injections Safe for Humans

The first FDA-approved clinical trial shows the safety of hydrogel injections intended to repair the human heart after a cardiac arrest.

Image courtesy of Shutterstock

Image courtesy of Shutterstock

Evolution may have something to do with humans vulnerability to cardiovascular diseases. The loss of a single gene, millions of years ago, could explain the tendency of humans to get heart attacks.

In the United States, approximately every 40 seconds, someone has a heart attack, with 735,000 new heart attack cases each year.

Patients who survive a heart attack or a myocardial infarction, are left with a damaged heart muscle. Following a heart attack, scar tissue forms as a natural response to contain the damage.

Unfortunately, the scar doesn’t go, which affects the heart’s contracting ability.

Now, a company suggests hydrogel injections as a treatment for repairing damaged cardiac tissue, and its product has just passed the first test.

Hydrogel Injections for Cardiac Repair

The heart muscle can’t regenerate its tissue to get back where it was before a heart attack. Its healing process involves the formation of scar tissue, which can’t contract like healthy tissue, exposing the muscle to a greater burden down the road.

Post-heart attack, patients have limited treatment options that mostly aim to reduce the risk for a future heart attack. But maybe they have every hope to repair their hearts!

Based in San Diego, CA, Ventrix, Inc. is a University of California San Diego spin-off company that develops injectable hydrogel, designed to repair cardiac tissue after a heart attack.

Now, Ventrix’ hydrogel injections for heart repair have just passed the FDA-approved Phase 1 clinical trial, meaning they’re safe for human subjects.

Other than being the first test of a hydrogel designed for cardiac repair, it is also the first time a hydrogel made from the natural scaffolding of cardiac muscle tissue, known as extracellular matrix (ECM), has been tested.

The Phase 1 trial showed Ventrix hydrogel injections, dubbed VentriGel, to be safe for patients who had a heart attack in the past 2 to 36 months.

The trial involved 15 patients, twelve were men, with moderate damage in the left ventricle of the heart following a heart attack. Each received up to 18 VentriGel injections into the ventricle via a catheter. Then patients were followed up by researchers for six months.

The results of this first-in-human study of heart-repair hydrogel injections show that patients experienced an improvement in heart function.

“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. “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.”

VentriGel is made from extracellular matrix taken from pigs that are freeze-dried and ground into fine powder. Then, it was liquefied to be quickly injected into the heart muscle via a catheter.

At body temperature, the liquid turns into a semi-solid, porous gel.

Myocardial infarction patients can expect more news about hydrogel injections for heart repair as the team is preparing for VentriGel’s Phase 2 clinical trial. After proven safe to inject in humans, VentriGel’s effectiveness in heart repair will be tested.

Read More: New Dual Stem Cell Approach to Heart Regeneration

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Zayan Guedim

Trilingual poet, investigative journalist, and novelist. Zed loves tackling the big existential questions and all-things quantum.

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