Blood Purification for Organ Failure

Sentien Biotechnologies is developing cellular devices for the treatment of acute organ failure, including polytrauma-induced multiple organ dysfunction syndrome (MODS). Our flagship product, the Sentinel, is a dialyzer with mesenchymal stem cells (MSCs) seeded in the extracapillary space, designed to connect to the bloodstream of patients and provide anti-inflammatory, cytoprotective and regenerative support via secreted factors from the MSCs. We propose here, in this Phase I and Phase I Option plan, to begin testing of the Sentinel in a polytrauma model in swine. For the Phase I period, we propose to work in conjunction with several key consultants to compose an IACUC-approved protocol for administration of our therapy to swine subjected to polytrauma and shock. This protocol will be based on a previously developed model of polytrauma that was devised by our collaborators, and it is with their help that we also plan to analyze the cytokine and myoglobin profile of banked samples from their previous work during the Phase I Option period. By accomplishing these two important tasks, we anticipate being well poised to evaluate the applicability of the porcine model, and assess our device treatment for polytrauma in swine during follow-on Phases of SBIR support.