Hls16-07: Manufacturing Tissue Engineered Patch to Treat Heart Failure
Award last edited on: 12/5/2017

Sponsored Program
Awarding Agency
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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

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HLS16-07 - Chronic heart failure (CHF) is a leading cause of morbidity and mortality worldwide with over 600,000 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: 1) human neonatal dermal fibroblasts and 2) 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.

Public Health Relevance Statement:
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 600,000 new cases yearly in the United States.

Project Terms:
Adhesions; Allogenic; Animal Model; base; Bioreactors; Blood flow; Cardiac; Cardiac Myocytes; cell type; Cells; Congestive Heart Failure; Coupling; Cryopreservation; Data; Dermal; design; Diabetic Foot Ulcer; Disease; DNA; Environment; Equilibrium; Excision; Family suidae; FDA approved; Fibroblasts; Freezing; functional improvement; Genetic Transcription; Glycolic-Lactic Acid Polyester; Grant; Growth; Heart; Heart failure; heart function; Hour; Human; Immune; Immune response; Implant; improved; in vivo; Individual; induced pluripotent stem cell; Infarction; Laboratories; Left; Left Ventricular Function; Left ventricular structure; manufacturing process; Marketing; Measurement; Medical; Metabolism; Methods; Microscopy; Modeling; Morbidity - disease rate; mortality; Myocardial; Myocardium; neonatal human; Patients; Performance; Phase; Process; protein expression; Quality of life; Rattus; Reagent; reconstitution; regenerative; response; scale up; Secure; Seeds; Small Business Innovation Research Grant; stem cell technology; Stem cells; Sterility; Surface; Techniques; Temperature; Testing; Tissue Engineering; Tissue Viability; Tissues; Transplantation; United States; Ventricular; Work

Phase II

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