Development and Assessment of an Engineered Cardiac Tissue for Treating Dilated Cardiomyopathy

Avery Therapeutics, Inc., Tucson AZ

Investigators

Abstract

Abstract Non-ischemic dilated cardiomyopathy (DCM) is a progressive disease that causes global left ventricular (LV) and right ventricular (RV) dysfunction leading to heart failure and death. The prognosis for non-ischemic DCM is poor, with data suggesting close to 50% 5-year mortality without a heart transplant. The prevalence is 5-8 cases/100,000 population/year with a high incidence in patients <60 years old. The treatment includes aggressive pharmacologic therapy, chronic resynchronization therapy (RCT), CardioNEMS? type monitoring and ventricular assist devices. None of these treatments addresses the primary pathology of DCM, loss of functioning cardiomyocytes. Ultimately, the only effective treatment for DCM is heart transplant, however, the number of donor organs is limited and has been stagnant for decades. A new treatment that replaces lost cardiomyocytes and improves cardiovascular function would provide a much-needed therapy for patients with DCM. Avery Therapeutics proposes a new treatment for non-ischemic DCM using a bioengineered cardiac tissue (MyCardia?) that can generate new myocardium and reverse maladaptive LV remodeling in animal models of ischemic chronic heart failure (CHF). Specifically, we have shown that MyCardia generates new cardiac myocytes, reverses left ventricular (LV) maladaptive remodeling, reduces LV volumes, improves LV systolic and diastolic function, electrically enhances conduction in the native myocardium with no electrical dyssynchrony, no arrhythmias, and activates endogenous growth factor secretion that increases myocardial blood flow. We believe that we can achieve these same benefits in patients with non-ischemic DCM, resulting in function and quality of life improvements. These positive changes should translate into benefitting patients with less shortness of breath and increases in functional capacity with improved exercise tolerance. We propose to develop a therapy for both dogs and humans.