Development and Assessment of an Engineered Cardiac Tissue for Treating Dilated Cardiomyopathy
Award last edited on: 4/30/20

Sponsored Program
Awarding Agency
Total Award Amount
Award Phase
Solicitation Topic Code

Principal Investigator
Steven Goldman

Company Information

Avery Therapeutics Inc

4425 Westflying Diamond Drive
Tucson, AZ 85742
   (928) 607-7410
Location: Single
Congr. District: 02

Phase I

Contract Number: 1R43HL144332-01A1
Start Date: 5/15/19    Completed: 4/30/21
Phase I year
Phase I Amount
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.

Public Health Relevance Statement:

Project narrative:
Dilated cardiomyopathy results in a poor prognosis and 50% 5-year mortality without heart transplant. Avery Therapeutics is developing a new treatment for dilated cardiomyopathy, an allogeniec tissue engineered graft, which provides electrical and structural benefit over a large area of the heart. We intend to finalize our quality manual, release criteria, and pre-clinical requirements before submitting an application to the FDA to test in a genetically defined canine dilated cardiomyopathy population.

Project Terms:
Activities of Daily Living; Address; Alcoholism; Animal Model; Animals; Area; Arrhythmia; Authorization documentation; base; Biodistribution; Biological Assay; Biomedical Engineering; Blood flow; Canis familiaris; Cardiac; Cardiac Myocytes; cardiac tissue engineering; Cardiovascular Physiology; Cell physiology; Cell Therapy; Cells; Cessation of life; Chronic; Client; Clinical; Clinical Trials; Congestive Heart Failure; Cyclic GMP; Data; Dermal; Development; Dilated Cardiomyopathy; Disease; Documentation; effective therapy; efficacy study; Endothelial Cells; Evaluation; Exclusion Criteria; Exercise Tolerance; Fibroblasts; Grant; Growth Factor; Heart; Heart Diseases; Heart failure; heart function; Heart Transplantation; Human; Implant; improved; Incidence; induced pluripotent stem cell; Investigation; Left; Left Ventricular Remodeling; loss of function; Manuals; manufacturing process; Methods; Monitor; mortality; Myocardial; Myocardial dysfunction; Myocardial Ischemia; Myocarditis; Myocardium; Organ; Organ Donor; outcome forecast; Pathology; Patients; Pharmaceutical Preparations; Pharmacology; Phase; Phase I Clinical Trials; Polymers; Population; pre-clinical; preclinical study; Prevalence; Process; Progressive Disease; Quality of life; Right Ventricular Dysfunction; safety study; Shortness of Breath; Site; Small Business Innovation Research Grant; Structure; Sudden Death; Survival Rate; Testing; Therapeutic; Thick; Thinness; Thromboembolism; tissue culture; Tissue Engineering; Tissues; Translating; Undifferentiated; Ventricular; ventricular assist device; Veterinarians; Virus; W

Phase II

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Start Date: 00/00/00    Completed: 00/00/00
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