Cellular Device for the Treatment of Acute Liver Failure

描述(申请人提供)：这个第一阶段项目的目标是开发一种用于治疗急性肝功能衰竭的细胞涂层设备。该设备利用间充质干细胞分泌物提供抗炎和再生支持。该项目的具体目标是：(1)正电子发射断层扫描(PET)引导的细胞涂层的优化；以及(2)在扑热息痛诱导的狗肝衰竭模型上进行剂量递增治疗试验。这一已完成项目的交付成果将是治疗性证据- 在第二阶段资助期间可以在大型动物身上进行优化的概念数据。 与公共健康相关：生物技术公司已经开发出一种体外设备，该设备有可能为急性肝功能衰竭患者提供无与伦比的支持。这款Sentien设备为患者提供了一系列来自间充质干细胞的广谱分泌因子。总而言之，这些因子保护受损器官免受炎症，并促进内源性修复计划。这种肝脏治疗的组合方法有别于竞争对手，并有望成为一项颠覆性的技术。Sentien现在寻求资金，通过创建优化的细胞涂层并在大型动物肝功能衰竭模型上进行随后的体内测试来完成其临床前开发。在这些研究结束时，Sentien希望有足够的临床前疗效证据来推动这种设备在人体上的初步试验。

DESCRIPTION (provided by applicant): The goal of this Phase I project is to develop a cell-coated device for the treatment of acute liver failure. The device harnesses mesenchymal stem cell secretions to provide combined anti-inflammatory and regenerative support. The project specific aims are: (1) Positron emission tomography (PET)-guided optimization of cellular coatings; and (2) To perform a dose escalation therapeutic trial in an acetaminophen-induced liver failure model in dogs. The deliverable of this completed project will be therapeutic proof-of concept data that can be optimized in large animals during Phase II funding. PUBLIC HEALTH RELEVANCE: Biotechnologies Inc. has developed an extracorporeal device that has the potential to offer unparalleled support to patients undergoing acute liver failure. Th Sentien device delivers to the patient a broad-spectrum array of secreted factors from mesenchymal stem cells. Collectively, these factors protect the injured organ from inflammation and promote endogenous repair programs. This combinatorial approach to liver therapy is distinguishable from the competition and promises to become a disruptive technology. Sentien now seeks funding to finalize its pre-clinical development by creating optimized cellular coatings and performing subsequent in vivo testing in large animal models of liver failure. At the end of these studies, Sentien expects to have sufficient evidence of pre-clinical efficacy to motivate initial trials of this device in humans.