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 from the Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital 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.
Learn more: FDA Phase 1 Trial Shows Hydrogel to Repair Heart Is Safe to Inject in Humans—A First
The Latest on: Heart repair
[google_news title=”” keyword=”heart repair” num_posts=”10″ blurb_length=”0″ show_thumb=”left”]
via Google News
The Latest on: Heart repair
- Insights into India’s growing heart health crisison May 8, 2024 at 11:37 am
Aortic stenosis with a high mortality rate is a significant cardiovascular concern. Non-surgical aortic valve replacement emerges as a game-changer Aortic stenosis stands as one of India’s most ...
- 4C Medical wins dual FDA breakthrough nods for mitral valve replacement deviceon May 8, 2024 at 7:27 am
C Medical Technologies announced today that the FDA granted breakthrough device designation for its AltaValve system.
- Protein marker unveiled for identifying blood vessel repair cellson May 7, 2024 at 10:15 pm
Researchers have discovered a protein marker to help identify cells able to repopulate in patients with damaged blood vessels.
- New transcatheter heart valve shows promise in treating aortic stenosison May 6, 2024 at 8:04 am
Recent findings from a study on a transcatheter heart valve (THV) system, which includes a new class of transcatheter aortic valve, showed positive results in the device's ability to function as a ...
- Are these robots making humans obsolete for home and repair tasks?on May 6, 2024 at 3:00 am
Kurt “CyberGuy" Knutsson reveals how the Aloha Unleashed project showcases a dual-arm robot system that autonomously performs tasks, demonstrating remarkable precision in robotics.
- Brief anger could lead to heart attack, study findson May 5, 2024 at 1:20 pm
ability to repair cells and other cellular function before, during and after the emotion-provoking experience. Those who were angry had contracted blood vessels for up to 40 minutes after the emotion ...
- New Study Finds How Being Angry Can Raise Your Risk of Heart Attackon May 4, 2024 at 1:00 pm
Previous scientific studies have suggested that there might be a connection between feelings of anger and an increased risk of heart attack. Now, some new research seems to illuminate why that is.
- Menopause hormone therapy may not help prevent heart diseaseon May 1, 2024 at 5:00 pm
More recent ones, Chen explained, did not find the same results, however. “Because of this, we have recommended against the use of hormone replacement therapy for heart disease prevention for quite ...
- Study: Women can safely use hormone replacement therapy during menopauseon May 1, 2024 at 1:58 pm
Hormone replacement therapy can safely ease middle-aged women's symptoms during early menopause, data from a major women's health study show.
- Anger could raise long-term risks for heart diseaseon May 1, 2024 at 7:37 am
Feeling angry constricts blood vessels in unhealthy ways and could raise a person's long-term odds for heart disease, new research warns.
via Bing News