Researchers based at the University of California – San Diego have successfully run a first-in-human, U.S. FDA-approved Phase 1 clinical trial into an injectable hydrogel. Hydrogel has been developed to repair damage and restore cardiac function in heart failure patients (those who have previously suffered a heart attack).
The trial is pioneering in terms of it being the first such clinical trial to test a hydrogel designed to repair cardiac tissue. The trial was also the first to test a hydrogel constructed from the natural scaffolding, composed of cardiac muscle tissue.
What are hydrogels?
A hydrogel is a network of polymer chains that are hydrophilic (which renders them capable of holding large amounts of water in their three-dimensional networks). They are sometimes found as a colloidal gel in which water is the dispersion medium.
Hydrogel technologies are being applied to hygienic products, agriculture, drug delivery systems, sealing, biomedical applications like tissue engineering and regenerative medicines and as biosensors.
One example of the application of hydrogels is with wound care. The benefits of using hydrogel-based dressings are that they gels provide moisture to a dry lesion. This means hydrogel dressings act fast to help cool down a wound, as well as provide temporary relief from pain.
With biomedical applications, recent advances with hydrogels have substantially enhanced their mechanical properties; made them ‘super-porous’; and increased response times, and led to self-assembling hydrogels.
Injectable hydrogel to repair damage and restore cardiac function
The new development comes from Ventrix (a University of California San Diego start-up). The venture has successfully conducted a first-in-human 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.
A Phase 1 clinical trial is a small trial, recruiting a few patients. Phase 1 trials, in general, aim to find out: how much of the drug is safe to give; what the side effects are; and how the body gets rid the of drug or medical device.
The trial was the world’s first to test a hydrogel designed to repair cardiac tissue and it used natural scaffolding of cardiac muscle tissue (extracellular matrix, formed from cardiac connective tissue taken from pigs). This was seen as significant by the scientists since hydrogels have been shown in preclinical studies to potentially be effective for other conditions, like poor blood circulation arising peripheral artery disease.
The new trial demonstrated that the hydrogel (called VentriGel) can be safely injected via catheter into patients who had suffered a heart attack during the past 2 to 36 months. When injected in damaged cardiac muscle, the VentriGel hydrogel forms a scaffold which acts as a reparative environment, allowing healthy cells to migrate. This leads to increases in cardiac muscle, and has the effect of leaving less scar tissue, as well as delivering improvements in heart function.
Commenting on this, lead researcher Karen Christman said: “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.”
Improvements mean, Dr. Christman explains: “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.”
Research paper
The research has been published in the journal JACC: Basic to Translational Science. The research paper is titled: “First-in-Man Study of a Cardiac Extracellular Matrix Hydrogel in Early and Late Myocardial Infarction Patients.”
Essential Science
This article is part of Digital Journal’s regular Essential Science columns. Each week Tim Sandle explores a topical and important scientific issue. Last week we considered new research into soft drinks, both sugar and ‘diet’ varieties and the impact on human health. There is data connecting soft drink consumption and the risk of early mortality.
The week before we looked at the latest application of drones, for consumer deliveries, hobby use, and with military deployment, assessing these three innovations with drone technology.
