Cellular therapy using human hepatocytes is being evaluated worldwide as an alternative to organ transplantation in patients with liver-based metabolic disease and acute liver failure. The basis for clinical use has come from the demonstration of efficacy in animal models of acute and chronic liver disease.
Protocols have been developed for the isolation of hepatocytes from liver tissue under GMP conditions and also for improved methods of cryopreservation, so hepatocytes can be stored for later clinical use. Assays are used to assess the quality and function of the hepatocytes prior to transplantation. There are clinical protocols for administration of cells directly into the patient’s liver.