SBIR Phase I:Assembly and Storage of Cell-Derived Drug Delivery Devices

This Small Business Innovation Research (SBIR) Phase I project proposes the development of a stem cell-based extracorporeal device that can offer unparalleled support to 200,000+ patients undergoing severe acute kidney injury annually. The device delivers cell-derived secretions of anti-inflammatory and regenerative molecules directly into the bloodstream in a dynamic and sustained manner. A major gap in deploying this technology is defining optimal assembly and storage conditions, such that the cellular device can be inventoried and made ready for immediate deployment in hospital ICUs for this critically ill patient population. Our objective in this project is to scale up our prototype device, and to determine optimal biopreservation methods to achieve an off-the-shelf product for on-demand use in hospital ICUs. The broader commercial impact of this research will allow for extended storage of our device, removing the need for an ?assemble-and-ship-on-demand? distribution model. This will reduce costs and remove lead-time requirements for ordering, assembling, and shipping a product. Customers would have the devices on-site, ready for use. This would be a breakthrough for cellular devices and would lay the groundwork for extending this platform technology into other acute organ failure indications. The broader impacts of this effort include reducing the high mortality rate (>70%) and morbidity for these patients, many of whom progress to long-term renal disease. Significant cost savings to the health care system of up to $4B per year are also anticipated from reduced patient time in ICU, reduced time to hospital discharge, and fewer patients requiring long-term dialysis.