Algenix, Inc. is taking a bioartificial liver (BAL) developed at the University of Minnesota through a Phase I clinical trial. This bioartificial liver is intended for providing a temporary support to liver failure patients awaiting transplantation. The BAL employs porcine hepatocytes entrapped in a collagen matrix within the lumens of a hollow-fiber bioreactor. The FDA has approved a Phase I Clinical Trial to be conducted at the University of Minnesota. A continuing major challenge in its development will be to maximize hepatocyte density in the reactor and to develop an acceptable protocol of "shelf- storage." This proposed research, in its Phase I, will investigate the feasibility of increasing the cell loading density and the possibility of developing a method of storing and shipping the BAL. In the Phase I research only limited number of variables will be investigated, including collagen cell concentration, and loading and storage temperature. The effects of the experimental variables will be evaluated by assessing the viability and liver specific activities of the hepatocytes in the BAL. A successful Phase I will lead to a Phase II Grant to develop a pilot manufacturing process of the improved bioartificial liver for use in further large animal pre-clinical trials and clinical applications. PROPOSED COMMERCIAL APPLICATION: The liver assist device is intended to address the clinical needs of patients suffering from acute liver failure and to provide a "bridge" to liver transplant. The BAL would also serve as a treatment for patients requiring detoxification and for trauma patients whose otherwise healthy liver has shut down.