CorMatrix Cardiovascular and the Central Clinical Hospital of the Ministry of Interior in Warsaw (Centralny Szpital Kliniczny MSW) of Warsaw, Poland announced the successful enrolment and treatment of five patients in the first ever study evaluating the CorMatrix ECM delivered trans-epicardially for the improvement of myocardial function in patients at risk or suffering from congestive heart failure.
The RESTORE study is being conducted at the Central Clinical Hospital of the Ministry of Interior in Warsaw, Poland under the direction of study investigator Piotr Suwalski, chief of the Department of Cardiac Surgery. The objective of this study is to evaluate the safety of the CorMatrix ECM delivered trans-epicardially with a proprietary delivery system to patients with left ventricular ejection fraction (LVEF) 25 to 40% during coronary artery bypass grafting (CABG). The endpoints of the study include device related safety and improvement in global ventricular function. Echocardiograph and MRI data will be evaluated by Yale Cardiovascular Research under the direction of Alexandra Lansky. Patients will be followed for 18 months, with interim assessments being conducted at six months and 12 months post treatment.
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 stabilise, 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 (SIS) that has been shown to provide a biologically and mechanically favourable scaffold for cell incorporation, differentiation, and proliferation. The proprietary delivery system enables targeted implantation and uniform distribution of the CorMatrix ECM to the ischaemic regions of the myocardium to maximise recovery.
Suwalski comments, “It is very exciting to take part in a study like the RESTORE Study that has the potential to provide data in support of what would be the first time the potential of a patient’s own stem cells were harnessed for the treatment or prevention of congestive heart failure by restoring a natural matrix with the regenerative power of the heart. The CorMatrix ECM treatments and the delivery system provided safe and easy application of the CorMatrix ECM to the patients.”
Mark Slaughter, director of the Heart Transplant and Mechanical Assist Device programme at Jewish Hospital & St Mary’s HealthCare, as well as chair of the Department of Cardiovascular and Thoracic Surgery at the University of Louisville, USA adds, “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 favourable environment to enhance myocardial regeneration and promote sustained myocardial recovery. The RESTORE Study will further clarify this question and set the bar for future congestive heart failure technologies.”
“CorMatrix has been pursuing a viable treatment/prevention for CHF since our Company was founded. 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. We are excited to be advancing the development of this application of the CorMatrix technology to improve patient lives,” commented David Camp, CorMatrix Cardiovascular chief executive officer.