Trial Information

A Phase I/II Trial of Recombinant Human Keratinocyte Growth Factor (rHuKFG) for the Treatment of Steroid Refractory Gastrointestinal Acute Graft-versus-host Disease (aGvHD)

There are two processes that cause diarrhea as the clinical manifestation of graft versus
host disease. The first is the obvious immunologic attack on the colonic epithelium of the
recipient. Once this immunologic attack has been abated the recipient is left with a
colonic mucosa that is devoid of microvilli and has a smooth intestinal boarder. This is
frequently subject to superinfections from bacteria all of which cause the diarrhea to
continue. Researchers only endpoint to measure clinical response of immunosuppression is
the resolution of diarrhea. The human recombinant keratinocyte growth factor stimulates
the growth of colonic epithelium. The growth of colonic epithelium will in turn probably
ameliorate some of the diarrhea associated with graft versus host disease.