Artificial liver cuts mortality by 44%

In a major study conducted at
20 centers in the United States and Europe, a bioartificial liver reduced mortality
significantly among patients suffering from acute liver failure, the
dramatic loss of liver function that can cause death in days or even hours.
This is the first large-scale, prospective, randomized, multi-center trial
examining the effectiveness of any artificial liver support. Currently,
standard treatment consists of intensive, supportive care intended to keep
patients alive long enough that the liver might recover spontaneously or a
donor organ will become available for transplantation. From Cedars Sinai: BIOARTIFICIAL LIVER REDUCES MORTALITY BY 44% IN ACUTE LIVER-FAILURE PATIENTS

In a major study conducted at
20 centers in the United States and Europe, a bioartificial liver developed
by researchers at Cedars-Sinai Medical Center reduced mortality
significantly among patients suffering from acute liver failure, the
dramatic loss of liver function that can cause death in days or even hours.
Study results are published in the May issue of Annals of Surgery.

This is the first large-scale, prospective, randomized, multi-center trial
examining the effectiveness of any artificial liver support. Currently,
standard treatment consists of intensive, supportive care intended to keep
patients alive long enough that the liver might recover spontaneously or a
donor organ will become available for transplantation.

Acute liver failure is diagnosed when a massive loss of hepatic cells causes
severe liver dysfunction and life-threatening complications within six
months of the onset of symptoms. When this dysfunction occurs within the
first eight weeks after onset, liver failure is termed “fulminant.” When it
occurs in the period between eight weeks and six months, it is
“subfulminant” (or late-onset). In either case, few patients survive the
resulting fluid buildup in the brain, catastrophic bacterial infections,
multi-organ failure, blood-clotting abnormalities, respiratory problems,
kidney failure or other potential complications. It is estimated, in fact,
that up to 80 percent of patients will die unless they receive a liver
transplant.

In the United States, the causes of many cases of acute liver failure are
never identified, although precipitating factors can include toxic
poisoning, medication interactions or overdoses, metabolic disorders, and
some types of viral hepatitis.

Achilles A. Demetriou, MD, PhD, Chairman of Surgery at Cedars-Sinai and the
study’s principal investigator, has been pursuing treatments for acute liver
diseases since 1976 when he began studying liver cells at the National
Institutes of Health. He continued his research at Vanderbilt University,
coming to Cedars-Sinai in 1992 to launch the country’s first unit devoted to
managing massive acute liver failure.

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. “Typically, within
that time the patient’s condition is going to improve because his or her own
liver kicks in or a liver will be available for transplantation,” Dr.
Demetriou said.

The study was funded by Circe Biomedical Inc.

Cedars-Sinai is one of the largest nonprofit academic medical centers in the
Western United States. For the fifth straight two-year period, it has been
named Southern California’s gold standard in health care in an independent
survey. Cedars-Sinai is internationally renowned for its diagnostic and
treatment capabilities and its broad spectrum of programs and services, as
well as breakthroughs in biomedical research and superlative medical
education. The Medical Center ranks among the top 10 non-university
hospitals in the nation for its research activities.

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