Artificial Liver Finds Success in Two Patients
Author: PR Newswire via Screaming Media
Author Date: 2/3/2003
PITTSBURGH, Feb 3, 2003 /PRNewswire via COMTEX/ -- As part of a
national study, University of Pittsburgh Medical Center (UPMC)
researchers used an experimental artificial liver assist system that
helped stabilize two patients who were in acute liver failure and
close to death until donor organs were available for
transplantation. Both received successful transplants and are doing
well.

One patient received a liver transplant and the second patient
received a five-organ transplant that included the liver, small
bowel, stomach, pancreas and duodenum. She is the first patient to
be supported with the device for acute liver failure and then to
receive a multivisceral transplant.

UPMC is one of 12 centers participating in a multi-center Phase II
trial to evaluate the safety and effectiveness of the ELAD(R)
(Extracorporeal Liver Assist Device) Artificial Liver system
developed by VitaGen Incorporated of La Jolla, Calif., to
temporarily support patients in fulminant hepatic failure, acute
liver failure that has a sudden onset. The company hopes to enroll
30 patients in the study. Of 19 that have been enrolled so far, 13
have been supported with the device, say company officials.

UPMC participated in the company's Phase I trial as well. According
to VitaGen, 12 of 15 (80 percent) of the ELAD-treated patients in
that trial involving six centers had positive outcomes -- either
they were successfully bridged to transplantation or their livers
recovered and transplantation was not necessary. Five of nine (56
percent) of the control group patients, who received standard
medical treatment for fulminant hepatic failure, were transplanted
or recovered.

The ELAD is an external device that works in a similar fashion to
kidney dialysis, whereby waste products are removed from the blood.
A pump pushes the patient's blood through a catheter into a large
filter that separates blood cells from plasma, creating what is
called ultrafiltrate. The ultrafiltrate in turn passes through
cartridges containing a cultured human cell line and is then
returned through another catheter back to the patient.

It is hoped that the cells contained in the device may provide some
of the vital functions that a normal, healthy liver does, such as
metabolizing toxins and producing beneficial proteins.

"Despite the best that medicine can offer, chances are not always
good that patients in fulminant hepatic failure will survive even
the shortest wait for donor organs. Having a means of temporary
support for these patients could buy them precious time and may even
allow their livers to recover," noted Peter Linden, M.D., D.M.D.,
associate professor of critical care medicine at the University of
Pittsburgh School of Medicine, critical care director of the liver
transplant intensive care units at the University of Pittsburgh
Medical Center and principal investigator for the Pittsburgh study
site.

"Development of an artificial liver is a daunting challenge because
of the many complex functions that the liver performs. But the need
is urgent, as more than 2,000 patients needing liver transplants die
on the national waiting list each year. This number could be reduced
if we had an artificial liver to support some of these critically
ill patients," added George V. Mazariegos, M.D., associate professor
of surgery at the University of Pittsburgh's Thomas E. Starzl
Transplantation Institute.

Of the more than 80,000 patients awaiting organ transplants in the
United States, about 17,000 are in need of livers. At any given
time, approximately 5 percent of these patients are patients in
acute liver failure who are not expected to live beyond seven days
without transplants.

Patients with fulminant hepatic failure who are eligible for the
study will be randomized to undergo experimental treatment with the
device in addition to standard treatment or to receive standard
treatment alone. Patients randomized to the device will undergo
experimental treatment 24 hours a day until successful liver
transplantation or spontaneous recovery of liver function occurs.
Treatment with the ELAD would not be expected to go beyond 10 days