CorMatrix Study to Improve Myocardial Function Underway

CorMatrix Cardiovascular Inc. has launched a study to evaluate the impact of an extracellular biomaterial on myocardial function in patients at risk or suffering from congestive heart failure.

Five patients are enrolled in the trial at the Central Clinical Hospital of the Ministry of Interior in Warsaw (Centralny Szpital Kliniczny MSW), Poland. The RESTORE study is the first to examine the efficacy of the CorMatrix extracellular matrix (ECM) biomaterial, delivered trans-epicardially to congestive heart failure (CHF) patients. The study will evaluate the safety of the CorMatrix ECM delivered trans-epicardially to patients with left ventricular ejection fraction (LVEF) 25 percent to 40 percent during coronary artery bypass grafting. The endpoints of the study include device related safety and improvement in global ventricular function. Echocardiograph and magnetic resonance imaging data will be evaluated by Yale Cardiovascular Research; patients will be followed for 18 months, with interim assessments being conducted at six months and 12 months post-treatment.

“This First in Human study follows pre-clinical work that we’ve conducted at the University of Louisville demonstrating that CorMatrix ECM may provide a favorable environment to enhance myocardial regeneration and promote sustained myocardial recovery. The RESTORE Study will further clarify this question and set the bar for future CHF technologies,” said Mark Slaughter, M.D., director of the Heart Transplant and Mechanical Assist Device program at Jewish Hospital & St. Mary’s HealthCare, as well as Chair of the Department of Cardiovascular and Thoracic Surgery at the University of Louisville in Ky.

Heart failure (HF) or CHF is one of the world’s top cardiovascular disorders, with more than 5 million U.S. patients afflicted (the  number is expected to double over the next 10 years, according to industry estimates). In 2012, the direct and indirect cost of HF in the United States was estimated at $31 billion. The incidence of HF is increasing globally as well, with more than 1 million new cases diagnosed annually.

Current treatment options for HF include pharmacological therapy, cardiac resynchronization therapy, mechanical circulatory support devices, and heart transplant. In advanced HF, transplant offers the best opportunity for long-term survival, but this option is restricted to select patients and the number of available donor organs is limited and cannot meet the growing demand. These circumstances have promoted mechanical circulatory support devices as a treatment option aimed at restoring cardiac output. Left ventricular assist devices, which mechanically unload blood volume from the failing left ventricle into the aorta, have become a standard therapeutic option for bridging to transplantation or for permanent use in patients not eligible for heart transplantation with end-stage HF.

CorMatrix has developed an extracellular matrix device and an intra-myocardial delivery device that enables efficient implantation of the CorMatrix ECM directly into damaged cardiac tissue. Intra-myocardial delivery of the CorMatrix to mechanically stabilize, repair and recover infarcted regions of the heart could provide myocardial recovery for these heart failure patients. The CorMatrix ECM is an implantable material derived from porcine small intestine submucosa that has been shown to provide a biologically and mechanically favorable scaffold for cell incorporation, differentiation, and proliferation. The proprietary delivery system enables targeted implantation and uniform distribution of the CorMatrix ECM to the ischemic regions of the myocardium to maximize recovery, the company claims.

“It is very exciting to take part in a study like RESTORE that has the potential to provide data to support the harnessing of a patient’s own stem cells to restore a natural matrix with the regenerative power of the heart,” said Piotr Suwalski, M.D., study investigator and Chief of the Department of Cardiac Surgery at Central Clinical Hospital. “The CorMatrix ECM treatments and the delivery system provided safe and easy application of the CorMatrix ECM to the patients.”

The decellularized matrix material used by CorMatrix serves as a bioscaffold to allow vascular ingrowth from adjacent tissues to deliver progenitor cells and nutrients to the matrix, which then differentiate into tissue-specific cells and structures. The ECM material gradually is replaced as the patient’s own cells reinforces and rebuilds the diseased or damaged site. During repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where damaged or injured tissue would normally be expected.  Since 1999, an estimated two million patients worldwide have received an extracellular matrix implant, the company estimates.

“Studies using isolated stem cell treatments to correct CHF have not resulted in relevant clinical benefits. Harnessing the power of our body’s own supply of stem cells, CorMatrix provides a natural environment, allowing these cells to repair damaged tissue structures,” CorMatrix CEO David Camp said.

Founded in 2001, CorMatrix Cardiovascular Inc. is a privately held developer of biomaterial devices that harness the body’s ability to repair damaged cardiovascular tissues. Headquartered in Atlanta, Ga., the company has U.S. clearance and European approval for its ECM technology as an implant for pericardial closure, cardiac tissue repair, and carotid repair.