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

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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HL132673-01A1
Application #
9200869
Study Section
Special Emphasis Panel (ZRG1-CVRS-C (10)B)
Program Officer
Lundberg, Martha
Project Start
2016-08-18
Project End
2017-07-31
Budget Start
2016-08-18
Budget End
2017-07-31
Support Year
1
Fiscal Year
2016
Total Cost
$483,960
Indirect Cost
Name
Avery Therapeutics, Inc.
Department
Type
DUNS #
079299809
City
Tucson
State
AZ
Country
United States
Zip Code
85742