HLS16-07: Manufacturing Tissue Engineered Patch to Treat Heart Failure

HLS Chronic heart failure CHF is a leading cause of morbidity and mortality worldwide with over new cases annually in the United States alone Although current medical treatments decrease mortality from CHF they do not reverse the disease process or restore long term cardiac function thus quality of life for patients is poor We have developed a biologically active cardiac patch MyCardia as a new treatment for CHF that is composed of two different cell types human neonatal dermal fibroblasts and human induced pluripotent stem cell derived cardiomyocytes hiPSC CMs We have already shown that MyCardia improves heart function in animal models of CHF In this SBIR grant we propose to develop manufacturing cryopreservation storage and reconstitution methods that will allow us to go all the way from the individual base units to a viable off the shelf MyCardia patch MyCardia has the potential to be the first Off the Shelf tissue engineered stem cell product to treat heart failure This project is designed to develop the manufacturing techniques for a new stem cell treatment for chronic heart failure using a bioabsorbable material unto which we seed stem cells This product has the potential to be the first Off the Shelf tissue engineered product to treat chronic heart failure We expect this product to restore heart function and improve quality of life of chronic heart failure patients currently over new cases yearly in the United States