Karen Christman (University of California in San Diego)
12 Sept. 2019. Results of a small-scale clinical trial show an experimental treatment using an injectable gel to repair damage from a heart attack is safe for patients. The findings, which also suggest improvements in heart functioning, appear in yesterday’s issue of the journal Basic to Translational Science published by American College of Cardiology.
The trial is testing a treatment for repairing damage to heart tissue that results from heart attack, developed in the lab of bioengineering professor Karen Christman at University of California in San Diego. A heart attack occurs when blood flow in one or more of the coronary arteries is blocked, reducing the amount of oxygen needed by heart muscles to function. Blockages often occur when cholesterol plaques building up in an artery break off and form a clot. Heart muscle tissue, in this circumstance, becomes damaged, with the amount of damage depending on the size of the area affected by the blockage. Scar tissue forms in the damaged area, and while the heart continues to pump blood, it becomes weakened as a result.
Christman’s lab studies bio-materials for repair and regeneration of heart tissue, including materials that can be injected into the heart. One of those materials is a hydrogel, a water-based biocompatible polymer, with extracellular matrix, the material making up the framework in cells, from heart muscles of pigs. The extracellular matrix is freeze-dried and milled into a powder, then mixed with water when needed. When injected into the heart, the liquid forms into a gel, with the extracellular matrix providing a scaffold for new heart muscle cells to build into healthy tissue, replacing the scar tissue from a heart attack.
The technology behind this treatment is licensed to Ventrix Inc., a company in San Diego co-founded by Christman. Ventrix conducted the early-stage clinical trial, recruiting 15 individuals age 45 to 69 who suffered a heart attack in the past three years, and experience moderate dysfunction of the left ventricle, the section of the heart that pumps blood to the rest of the body. Participants were injected with VentriGel, the product developed by Ventrix, using a catheter, with each injection taking about 45 seconds. Patients were then monitored and tracked for six months, looking primarily for signs of adverse effects.
The researchers say VentriGel was well-tolerated by patients, with none of the group discontinuing their participation in the trial. The first participant in the trial experienced the most adverse effects, cardiogenic shock — failure to pump blood — and a complete heart block that may have been caused by the treatment, but also from the patient’s previous heart blocks. No other adverse effects, say the researchers, were directly linked to the treatments.
“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,” says Christman in a university statement. After three and six months, participants could walk longer distances in six minutes, than before the treatments. Participants overall also improved on the New York Heart Association heart failure classification scale that measures limits on physical activity, and a quality-of-life index for people living with heart failure.
The company now plans a mid-stage study, with a larger randomized sample that tests the hydrogel treatment against a placebo, and measures more indicators of efficacy as well as safety.
More from Science & Enterprise:
- Math Model to Gauge Heart Attack Risk from Plaques
- Nanotube Fibers Configured for Heart Repair
- Spray-On Hydrogel Reduces Heart Surgery Scar Tissue
- Heart Components Produced with 3-D Printing
- Repair Patch Devised for Heart Attacks
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