Mesenchymal Stem Cell Bioreactor for the Active Treatment of Acute Renal Failure

描述（由申请方提供）：本项目的总体目标是设计一种用于治疗犬急性肾衰竭（ARF）的间充质干细胞（MSC）涂层透析器械的操作和监测的临床方案。该项目的具体目标是：（1）在ARF犬中生物标志物引导的Sentinel治疗的启动。(2)在ARF犬中进行Sentinel剂量递增试验。该已完成项目的可交付成果将是一种IND就绪器械治疗，将推进I期临床研究。 公共卫生相关性：Sentien Biotechnologies，Inc.开发了一种间充质干细胞（MSC）涂层装置，为急性肾功能衰竭（ARF）患者提供组合治疗支持。该装置以动态和持续的方式将MSC衍生的抗炎和再生分子分泌物直接输送到血流中。我们现在计划为ARF器械制定一项有效的临床方案，该方案应涵盖新药给药的关键组成部分，即（i）开始时间、（i）剂量和（iii）治疗持续时间，以便进行人体研究。

DESCRIPTION (provided by applicant): The overall goal of this project is to design a clinical protocol for the operation and monitoring of a mesenchymal stem cell (MSC)-coated dialysis device for the treatment of acute renal failure (ARF) in dogs. The project specific aims are: (1) Biomarker-guided initiation of Sentinel therapy in an ARF dogs. (2) Execute a dose escalation trial of the Sentinel in ARF dogs. The deliverable of this completed project will be an IND-ready device therapy that will be advancing towards a Phase I clinical study. PUBLIC HEALTH RELEVANCE: Sentien Biotechnologies, Inc. has developed a mesenchymal stem cell (MSC)-coated device that offers combinatorial therapeutic support to patients undergoing acute renal failure (ARF). The device delivers MSC-derived secretions of anti-inflammatory and regenerative molecules directly into the bloodstream in a dynamic and sustained manner. We now plan to develop an effective clinical protocol for the device for ARF that captures the critical components of a administering a new drug, namely (i) initiation time, (i) dose, and (iii) duration of treatment that will enable human investigation.