The overall goal of this Phase I project is to create technical protocols for the reproducible operation of our proprietary cell-based device for the treatment of acute renal failure. The project specific aims are: (1) To identify active therapeutic secreted factors from MSCs in order to develop quality control assays;and (2) To optimize standard operating procedures for the manufacturing of MSC-devices and perform a dose escalation trial in dogs. The deliverable of this completed project will be a prototype cell-laden dialysis cartridge that will be ready for therapeutic testing in large animal and human trials during Phase II funding.
Sentien Biotechnologies Inc. has developed a cell-based kidney dialysis device that offers unparalleled support to patients undergoing acute renal failure. The device, known as the Sentinel"""""""", delivers cell- derived secretions of anti-inflammatory and regenerative molecules directly into the bloodstream in a dynamic and sustained manner. This immunomodulatory and organ sparing approach distinguishes this device from current devices designed to provide artificial kidney support and promises to quickly become a disruptive technology in the realm of renal failure therapy. Sentien now seeks funding to continue to develop a pre-clinical pathway to commercialization of their proprietary technology. This pathway will involve an initial phase of identifying the key molecules secreted by MSCs for quality control purposes and then the creation of standard operating procedures that optimize the viability and secretions of MSCs during bioproccessing of a human scale device. A dose escalation study will be performed in dogs using the manufacturing protocols created for the Sentinel"""""""". A second phase of development will involve therapeutic trials in large animals and the clinical preparation and testing of the Sentinel"""""""" in a Phase I/II human trial.
|Li, Matthew; Tilles, Arno W; Milwid, Jack M et al. (2012) Phenotypic and functional characterization of human bone marrow stromal cells in hollow-fibre bioreactors. J Tissue Eng Regen Med 6:369-77|