Cellular Device for the Treatment of Acute Liver Failure

用于治疗急性肝衰竭的细胞装置

• 批准号: 8313302
• 负责人: Biju Parekkadan
• 金额: $ 30.79万
• 依托单位: SENTIEN BIOTECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8313302
• 关键词: Acetaminophen; Achievement; Acute; Acute Kidney Failure; Acute Liver Failure; Address; Ally; Animal Model; Animals; Anti-Inflammatory Agents; Anti-inflammatory; Artificial Liver; Bioreactors; Biotechnology; Blood; Businesses; Canis familiaris; Cell Count; Cell Survival; Cell physiology; Cell secretion; Cells; Chronic; Clinic; Clinical; Commit; Complex; Critical Illness; Data; Development; Devices; Dose; Drug Delivery Systems; Engineering; Environment; Fiber; Functional disorder; Funding; Germ Cells; Glycocalyx; Goals; Hepatocyte; Hepatology; Human; Hybrids; Image; Imaging Device; Immune response; Inflammation; Inflammatory; Injection of therapeutic agent; Investments; Letters; Liver; Liver Failure; Marketing; Medical; Membrane; Mesenchymal Stem Cells; Methods; Modeling; Monitor; Nutrient; Organ; Organ failure; Patients; Phase; Plant Roots; Poisoning; Positron-Emission Tomography; Procedures; Property; Rattus; Simulate; Small Business Innovation Research Grant; Stem cells; Subcutaneous Injections; Technology; Testing; Therapeutic; Therapy Clinical Trials; Time; Tissue Engineering; Translating; Transplantation; base; bioimaging; chronic liver disease; clinical efficacy; clinically relevant; combinatorial; commercialization; cost; effective therapy; in vivo; injured; liver transplantation; mortality; operation; patient population; pre-clinical; programs; prototype; regenerative; repaired; single molecule; tissue repair; tool

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.

描述（由申请方提供）：本I期项目的目标是开发用于治疗急性肝衰竭的细胞涂层器械。该设备利用间充质干细胞分泌物提供联合抗炎和再生支持。该项目的具体目标是：（1）正电子发射断层扫描（PET）引导的细胞涂层优化;和（2）在对乙酰氨基酚诱导的犬肝衰竭模型中进行剂量递增治疗试验。该已完成项目的可交付成果将是治疗证明， 可以在第二阶段资助期间在大型动物中优化的概念数据。 公共卫生相关性：生物技术公司开发了一种体外装置，有可能为急性肝衰竭患者提供无与伦比的支持。Sentien装置向患者递送来自间充质干细胞的广谱分泌因子阵列。总的来说，这些因素保护受损器官免受炎症的影响，并促进内源性修复程序。这种肝脏治疗的组合方法与竞争对手不同，并有望成为一种颠覆性技术。Sentien现在寻求资金，通过创建优化的细胞涂层并在大型肝衰竭动物模型中进行后续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激励该设备在人体中的初步试验。