Phase I/II Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD
Phase I/II Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD
Phase II efficacy evaluation, phase I/II efficacy and toxicity trial of recombinant human
 keratinocyte growth factor for the treatment of steroid refractory gastrointestinal graft
 versus host disease.
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.
Inclusion criteria:

 -  Patients post allogeneic bone marrow transplant with watery diarrhea progressed on
 2mg/kg of steroids after 3 days or failed to improve after 5 days.

 -  Patients may have skin or liver involvement with graft versus host disease.

 -  Patients should not have any infections etiology for diarrhea.

 Exclusion criteria:

 -  None