CELSIOR

Description of Event or Problem

A REPORT HAS BEEN RECEIVED FROM AN INVESTIGATOR CONCERNING A PT WHO HAD BEEN ENROLLED IN AN INVESTIGATOR-INITIATED STUDY ASSESSING EFFICACY OF CELSIOR FOR HEPATIC GRAFT PRESERVATION. THE PT'S MEDICAL AND SURGICAL HISTORY INCLUDED LIVER CIRRHOSIS IN 2001, APPENDECTOMY, CHOLECYSTECTOMY IN 2001, HEPATIC TRANSPLANTATION IN 2003. THE DONOR'S LIVER WAS RINSED IN-SITU AND EX-VIVO WITH CELSIOR, AND THEN COLD PRESERVED IN CELSIOR SOLUTION. TWO DAYS AFTER TRANSPLANTATION, THE PT HAD DEVELOPED ACUTE HEPATIC CYTOLYSIS (TRANSAMINASES INCREASED 200-FOLD) AND HEPATIC NECROSIS REPORTED TO MANUFACTURER AS UNLIKELY TO BE RELATED TO STUDY DRUG (CELSIOR). IN 2003, THE PT DEVELOPED CHOLESTASIS WITH INCREASED AST/ALT, ALK PHOS AND GGT. TWO MONTHS AFTER TRANSPLANTATION, THE PT DEVELOPED ARTERIAL HEPATIC STENOSIS AND BILE DUCT STENOSIS WITH BILIARY FISTULA, CONFIRMED BY TRANS-HEPATIC CHOLANGIOGRAPHY. HEPATIC BIOPSY RULED OUT GRAFT REJECTION. THE PT UNDERWENT SUCCESSFUL ANGIOPLASTY. AT THE TIME OF EVENT, THE PT HAD A LONG TERM TREATMENT INCLUDING CORTANCYL (PREDNISONE), MOPRAL (OMEPRAZOLE) AND NEORAL CYCLOSPORIN. THE INVESTIGATOR CONSIDERED THE EVENTS HEPATIC ARTERY AND BILE DUCT STENOSIS TO BE RELATED TO CELSIOR.