The goal of this Fast-Track Phase I/II SBIR is to test a novel extracorporeal system for delivering mesenchymal stem cell (MSC) secretions to treat acute myocardial infarction (MI). We will use the Sentien proprietary extracorporeal delivery system to treat swine subjected to a clinically relevant model of MI. The project specific aims are: (1) Simulated blood perfusion to select most potent MSC bioreactor membrane (Ph. I); (2) Stability analysis of manufactured Sentinel devices (Ph II); and (3) Therapeutic studies of MSC bioreactors in pigs with MI (Ph. II). Our Phase I milestone is the identification of dialyzer membrane to optimize MSC potency. The Phase II deliverables of the studies include (1) protocol for shipping and storage of our devices; (2) assessment of toxicity of our devices in healthy swine; (3) the ideal timing window for efficacious treatment of acute MI in swine; and (4) efficacy data compared to MSC transplantation. With the completion of the studies described herein, our bioreactor will be poised for immediate testing in human patients.
Sentien Biotechnologies Inc. has developed a patented bioreactor system for delivering the diverse array of therapeutic molecules secreted by human mesenchymal stem cells (MSCs) to treat primary tissue injury as a result of inflammatory organ ischemia. In this proposal, we seek to test the effectiveness of this technology to treat the damaging effects of myocardial infarction (MI). We hypothesize application of the diverse array of cytokines, cytokine receptors, anti-inflammatory lipid mediators and growth factors naturally metabolized and secreted by MSCs in the context of MI will bring about improved healing and result in significant increases in cardiac function, thereby lessening the burden of this disease and decreasing mortality. With the completion of the studies proposed, Sentien will be poised to rapidly advance this technology into clinical studies to meet this critical unmet need.
