BIOARTIFICIAL LIVER DEVICES

Abstract

A current treatment for acute liver failure, the hybrid bioartificial liver (BAL) device, includes biologically active cells in mechanical systems. A number of BAL devices are in development to serve as a bridge to transplant for patients with acute liver failure. Most of these devices, including ours, employ cultured cells in hollow fiber bioreactors. The considerations that attend the development of BAL devices will be discussed in this presentation. These considerations include cellular component, membrane component, and BAL system configuration. BAL devices based on hollow fiber bioreactors currently show the most promise, and available results to date will be reviewed. A majority of the BAL devices currently undergoing clinical trials utilize xenogeneic, porcine hepatocytes. The risks of using xenogeneic treatments have yet to be defined. Therefore, a stringent manufacturing process is required to ensure consistent quality and safety. Furthermore, the potential risk of cross-species transmission of possibly infectious, adventitious agents, such as porcine endogenous retrovirus, has raised safety concerns. The current status of xenogeneic BAL technology and regulations will be addressed in addition to public safety concerns and bioethical issues associated with BAL treatment. Finally, the technological experience gained from past and present BAL systems will be summarized and the future of BAL technology discussed with reference to performance and public safety.