HLS16-07: Manufacturing Tissue Engineered Patch 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，有超过 仅在美国，每年就有60万新病例。尽管目前的医疗治疗减少了 CHF的死亡率，它们不会逆转疾病的进程或恢复长期的心功能，因此质量 病人的生活质量很差。我们已经开发出一种具有生物活性的心脏贴片，MyCardia，作为一种新的 CHF的治疗由两种不同类型的细胞组成：1)人新生儿皮肤成纤维细胞和2) 人诱导多能干细胞来源心肌细胞(hiPSC-CMS)。我们已经证明了 MyCardia可改善CHF动物模型的心功能。在这笔SBIR赠款中，我们建议开发 制造、冷冻保存、储存和重建方法，将使我们能够从 将单个基本单位添加到可行的现成MyCardia补丁中。MyCardia有可能成为第一个 用于治疗心力衰竭的“现成”组织工程干细胞产品。

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.