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.
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.