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

HLS16-07：制造治疗心力衰竭的组织工程贴片

基本信息

批准号：
9200869
负责人：
Steven Goldman
金额：
$ 48.4万
依托单位：
AVERY THERAPEUTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-08-18 至 2018-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9200869
关键词：
Adhesions Allogenic Animal Model Bioreactors Blood flow Cardiac Cardiac Myocytes Cells Congestive Heart Failure Coupling Cryopreservation DNA Data Dermal Diabetic Foot Ulcer Disease Environment Equilibrium Excision FDA approved Family suidae Fibroblasts Freezing Genetic Transcription Glycolic-Lactic Acid Polyester Grant Growth Heart Heart failure Hour Human Immune Immune response Implant Individual Infarction Laboratories Left Left Ventricular Function Left ventricular structure Marketing Measurement Medical Metabolism Methods Microscopy Modeling Morbidity - disease rate Myocardial Myocardium Patients Performance Phase Process Quality of life Rattus Reagent Secure Seeds Small Business Innovation Research Grant Stem cells Sterility Surface Techniques Temperature Testing Tissue Engineering Tissue Viability Tissues Transplantation United States Ventricular Work base cell type design functional improvement heart function improved in vivo induced pluripotent stem cell manufacturing process mortality neonatal human protein expression reconstitution regenerative response scale up stem cell technology

项目摘要

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.

HLS16-07-慢性心力衰竭（CHF）是全球发病率和死亡率的主要原因仅美国，每年有60万例新案件。尽管目前的药物治疗下降 CHF的死亡率不会扭转疾病过程或恢复长期心脏功能，因此质量患者的生活很差。我们已经开发了一种生物学活跃的心脏贴片，菌根，作为新的由两种不同细胞类型组成的CHF的治疗：1）人类新生儿皮肤成纤维细胞和2个）人诱导的多能干细胞衍生的心肌细胞（HIPSC-CMS）。我们已经表明霉菌症改善了CHF动物模型中的心脏功能。在这项SBIR赠款中，我们建议开发制造，冷冻保存，存储和重建方法，使我们能够从单个基础单元，可备有可行的现成的菌丝菌补丁。菌根有可能成为第一个 “现成”组织工程干细胞产品以治疗心力衰竭。