ABSTRACT
I n spite o f substantial advances in general supportive therapy and critical care, m orta lity in fu lm inant hepatic failure (FHF) rem ains unacceptably high, due prim arily to incom plete understanding o f the pathophysiology o f the disease.1 Despite this, clinicians have attem pted to develop rational novel therapeutic m odalities focusing m ostly on plasm a detoxification.2-7 W hole liver perfusion using either h um an or xenogeneic organs has been used successfully to treat patients w ith FHF, bu t is lim ited by lack o f hum an livers and logistical considerations in the case o f anim al organ use.8-9
In previous sections o f this m onograph we presented the rationale for using in tact isolated cryopreserved hepatocytes to develop a bioartificial liver (BAL). Several investigators have developed and tested a variety o f hepatocyte-based system s.10-15 We have developed a BAL containing porcine hepatocytes and have dem onstrated its ability to provide detoxifying and synthetic functions in a series o f in vitro and in vivo anim al experim ents as well as p ilot clin ical s tu d ies .2,16-20 T he system has b een describ ed in d e ta il in ea rlie r sec tions o f th is m o n o g rap h as well as in a m ore recent publication .21 Based on the data collected from these studies, BAL design was optim ized, and we arrived at the system used in the clinical tr ia l d escribed here . T he p u rp o se o f th is sec tion is to p ro v id e an u p d a te o f th e clin ical experience w ith o u r BAL.
