Abstract
Hepatocyte growth factor (HGF), a potent mitogen for heptaocytes, was purified from the plasma of patients with fulminant hepatic failure in 1986. The molecular mechanisms underlying the functions of HGF are currently being examined in detail using in vitro and in vivo experiments. Through these investigations, HGF has shown potential as a new therapeutic agent for the treatment of fatal liver diseases. We have worked for many years to make recombinant human HGF (rh-HGF) available as a drug. We performed a translational medicine protocol with rh-HGF: after performing a number of preclinical tests with rh-HGF, we started an investigator-initiated ICH-GCP registered phase I/II clinical trial in 2005 for the treatment of fulminant hepatic failure, to examine the safety and clinical efficacy of rh-HGF. Tewnty patients with FH or LOHF were evaluated for participation in this clinical trial, and four patients were enrolled. Repeated doses of intravenous rh-HGF did not induce severe adverse events, and was well tolerated in patients with fulminant hepatic failure. It is desirable to conduct further investigations to determine the efficacy of rh-HGF.
