A study presented this week at the American Heart Association (AHA; Dallas) Scientific Sessions in New Orleans shows that an injectable version of a biomaterial designed to enable a patient's own cells to repopulate and repair damaged tissues, improved cardiac function in rats.

CorMatrix Cardiovascular (Marietta, Georgia) said the study demonstrated that an emulsified version of its Extracellular Matrix (ECM) technology improved cardiac function. The study tested the hypothesis that an injection of ECM emulsion into infracted myocardium would promote wound healing and angiogenesis by naturally recruiting c-kit positive cells, the company noted.

Beecher Lewis, president/COO and co-founder of CorMatrix, told Medical Device Daily while on his way back to Atlanta from New Orleans that the study was well received at the AHA meeting. He said there are a lot of other researchers across the globe trying to pursue the same type of treatment, but with a cell-based approach.

"We've already received a lot of very positive feedback," Lewis said. He said a number of researchers approached Robert Matheny, MD, chief scientific officer of CorMatrix, after he presented the data, who responded "very favorably, saying things like cells alone are probably not the answer.'"

The study involved rats that were subjected to 45 minutes of coronary occlusion, followed by three, seven, 21 and 42 days of reperfusion with and without the ECM emulsion injection, respectively.

"Reinforcing our earlier findings, the subjects that received the emulsified ECM injection over an extended period showed significant reversal of cardiac damage and improvement in overall function following the induced occlusion," Matheny said. "The improved heart function we observed at 42 days is consistent with prior data and further demonstrates the technology's promise and sustainability."

At seven days post-reperfusion, the population of c-kit positive cells within the emulsion area increased significantly compared to the control and myofibroblasts accumulated in the emulsion region to a significant extent, according to the company.

Angiogenesis in the emulsion area was significantly enhanced, evidenced by increased density value of a-SMA-positive vessels and vWF-positive vessels. At 42 days post reperfusion, echocardiography showed improvements in end-systolic volume, fractional shortening and ejection fraction in the emulsion group. The wall thickness of the infarcted middle anterior septum was also significantly greater in the emulsion group, CorMatrix noted.

"We are committed to conducting ongoing pre-clinical research as we help to further increase physicians' awareness and understanding of the significant role that extracellular matrix materials can have in cardiac applications," Lewis said. "We will continue pre-clinical trials with our next generation ECM technology product and look forward to eventually moving to clinical trials to determine its ability to ultimately reverse the effects of heart failure in humans."

According to CorMatrix, the use of extracellular matrix technology in non-cardiovascular applications has established a significant foothold in soft tissue repair, wound management and orthopedic applications.

In May, the company reported an additional indication from FDA for its ECM technology, which expanded the use of ECM to include suture-line reinforcing, buttressing for soft tissue reaproximation, repair of cannulation sites and bleeding sites, and as an intracardiac patch or pledget for tissue repair or structural problems such as septal defect (Medical Device Daily, May 13, 2008).

The initial FDA clearance, which the company received in August 2005, was for the reconstruction and repair of the pericardium during cardiac surgery. The technology was developed in the 1990s at Purdue University (West Lafayette, Indiana).

In other news from the AHA conference, a study of nearly 18,000 patients with normal cholesterol but elevated levels of high sensitivity C-reactive protein (hsCRP) has shown that a simple blood test can spot seemingly healthy people who are at increased risk for a heart attack or stroke.

In the randomized, double-blind study of 17,802 men and women, a lipid-lowering drug reduced heart attacks by 54% in people who had normal cholesterol but elevated levels of hsCRP. The JUPITER trial was presented as a late-breaking clinical trial. The study was simultaneously published in the New England Journal of Medicine.

"Compared to those who received placebo, patients receiving the drug rosuvastatin also had a 48% reduction in stroke, a 46% reduction in the need for interventions to reopen blocked blood vessels and a 20% drop in all-cause mortality," said Paul Ridker, MD, lead author of the study and director of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital (Boston).

The trial included men over age 50 and women over age 60 with no history of cardiovascular disease, with LDL "bad" cholesterol levels below 130 mg/dL and hsCRP greater than or equal to 2 mg/L. to 190/100. They could have other risk factors for cardiovascular disease, such as high blood pressure up to 190/100, obesity, current smoking, abnormal glucose tolerance (but not frank diabetes) and/or the metabolic syndrome, and/or a family history of premature heart disease.

Overall, compared to placebo-treated participants in the trial, those given rosuvastatin had a 44% reduction in the primary endpoint of a first major cardiovascular event – a composite of heart attack, stroke, revascularization, hospitalization for unstable angina and cardiovascular death – the study authors noted. Hospitalizations for cardiac reasons were also reduced and the authors suggested that the strategy tested in JUPITER of treating elevated hsCRP patients with statin therapy could be cost-effective.

Ridker said one particularly striking finding was a 37% reduction in first events in men and women in the statin group who had no other risk factors except for elevated hsCRP, a sign of inflammation that can be associated with increased coronary disease risk.

The researchers found no increase in the number of patients with either muscle pain or cancer among those given rosuvastatin. As in almost all prior statin trials, they observed a small increase in reported diabetes, said Ridker, the Eugene Braunwald Professor of Medicine at Harvard Medical School (Boston).

Study participants, who were recruited from 1,300 sites in 26 countries, were randomly assigned to 20 milligrams of rosuvastatin a day or a daily placebo. The study's independent data and safety monitoring board ended the trial in March, more than two years ahead of schedule, when it determined that the study data indicated "unequivocal benefit of rosuvastatin" on coronary-related death and disability.

"Not only do we confirm that apparently healthy men and women with elevated hsCRP are at high risk of cardiovascular events, but we demonstrate that a simple therapy can reduce their risk of heart attack, stroke or cardiovascular death," Ridker said.

The study was sponsored by AstraZeneca (London).