The study included 147 patients who suffered from fulminant/subfulminant hepatic failure and 24 patients whose livers had failed after transplantation. Of the 171 total patients, 85 received BAL treatment, while 86 received standard supportive care.

For the entire patient population, survival at 30 days was 71 percent among the BAL group, compared with 62 percent for those receiving traditional care. Analyzing results among only the 147 patients with fulminant/subfulminant hepatic failure, the researchers found that the BAL provided a 44 percent reduction in mortality.

During a treatment, blood is drawn from a vein through a catheter. Blood plasma is separated from the serum and pumped through a charcoal column and an oxygenator before it reaches the bioreactor a tube-shaped device containing a fiber membrane and 7 billion liver cells from pigs. These cells are isolated, cryopreserved (frozen) and thawed according to techniques originally developed by the Cedars-Sinai researchers.

"The blood is removed at a fixed rate, detoxified and treated in the various components of the bioartificial liver, reconstituted, and returned to the patient at the same rate at which it is being removed," said Dr. Demetriou. "Just before the patient is treated, the pig liver cells are thawed, reactivated and attached to small beads that serve as a scaffold for the cells. We put the cells and beads into the cartridge, and when the patient's plasma flows through the fibers, the pig liver cells detoxify it and replace missing nutrients."

Each treatment is completed in about six hours, and the benefits last about 24 hours. In most cases of acute liver failure, a series of treatments may need to continue for only a few days or several weeks. "Typi
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Contact: Sandra Van
sandy@vancommunications.com
1-800-880-2397
Cedars-Sinai Medical Center
22-Apr-2004