This Small Business Innovations Research (SBIR) Phase I proposal is to demonstrate the feasibility of using Miromatrix' perfusion decellularization technology to create a fully revascularized cardiac patch for the treatment of ischemic heart disease and congenital heart repair. While medical advancements have decreased the overall mortality rate for acute myocardial infarction (MI) patients, therapeutic options are lacking to address the underlying loss of myocardial tissue, resulting in a mortality rate greater than 33% at five years. For congenital repair, current surgical approaches for cardiac reconstruction utilize synthetic materials that do not have the ability to grow and remodel with the patient. The proposed cardiac-derived revascularized cardiac patch may promote faster reconstruction of functional tissue by providing a fully perfusable scaffold with a composition and architecture similar to native cardiac tissue.
The broader/commercial impacts of this research are the development of a revascularized cardiac patch to treat ischemic heart failure and congenital repair. Inhibiting the onset or delaying the severity of heart failure will have a significant effect on reducing the treatment cost of heart failure, which currently is estimated at over $37 billion. This product with have significant advantages over existing technologies, including: 1) full thickness, biological, cardiac-derived matrix material; 2) vascular supply to support migrating cells and remodeling; 3) superior mechanical properties; and, 4) no need for immunosuppressive therapies. Moreover, this will be the first cardiac-derived, revascularized patch available for treating ischemic areas of the heart.
Project Summary: Intellectual Merit Miromatrix’ Small Business Innovations Research Phase I grant demonstrated the feasibility of using Miromatrix' perfusion decellularization technology to create a fully revascularized cardiac patch capable of maintaining physiological blood pressures for the treatment of ischemic heart disease and congenital heart repair. While medical advancements, including percutaneous coronary interventions ("PCI"), have decreased the overall mortality rate for acute MI patients, the lack of therapeutic options available to address the underlying loss of myocardial tissue results in patients’ progression towards Congestive Heart Failure ("CHF"), resulting in a mortality rate greater than 33% only five years following the initial event. For congenital repair, current surgical approaches for cardiac reconstruction utilize synthetic materials that do not have the ability to grow with the patient and do not provide any contractile function. Miromatrix’ cardiac-derived revascularized cardiac patch may promote faster reconstruction of functional tissue by providing a fully perfusable scaffold with a composition and architecture similar to the tissue that it is intended to replace. Broader Impacts The broader commercial impact of this research is the development of a revascularized cardiac patch to treat ischemic heart failure and congenital repair. The ability of the material to be remodeled and functionally grow with the patient will be of great value to repair congenital cardiac defects and to inhibit the progression towards heart failure following a myocardial infarction. Inhibiting the onset or delaying the severity of heart failure will have a significant effect on reducing the treatment cost of heart failure, which currently is estimated at over $37 billion in 2010 for indirect and direct costs. This product with have significant advantages over existing technologies including: 1) full thickness, biological, cardiac-derived matrix material; 2) vascular supply to support migrating cells and remodeling; 3) superior mechanical properties; and, 4) no need for immunosuppressive therapies. Moreover, this will be the first cardiac-derived, re-vascularized patch available for treating ischemic areas of the heart. Key Words: Tissue engineering, decellularization, extracellular matrix, cardiac patch, Topic: Biotechnology and Chemical Technologies BM5 - Tissue Engineering and Repair
