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

描述（由申请人提供）：该项目的总体目标是设计一种用于治疗犬急性肾功能衰竭（ARF）的间充质干细胞（MSC）包被透析装置的操作和监测的临床方案。该项目的具体目标是：(1)在ARF犬的生物标志物引导下启动前哨治疗。(2)在ARF犬中进行Sentinel剂量递增试验。该项目完成后的成果将是一种IND-ready设备疗法，并将进入I期临床研究。

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.