Albert Einstein Medical Center Enrolls First Patient in the U.S. in Clinical Trial for Artificial Liver Support Device
Einstein one of only two medical centers in the country to participate in
FDA-approved trial
Philadelphia, PA, December 6, 2005 – Albert Einstein Medical Center in Philadelphia has enrolled the first patient in the United States in a Food & Drug
Administration-approved Phase 1 safety trial of the SEPET™ artificial liver support device. Einstein is one of only two institutions
in the country selected to participate in the clinical trial, which is designed to assess the safety and efficacy of the
technology. The clinical trial will also evaluate the device’s potential as a blood purifier to provide temporary liver support
during acute-on-top-of-chronic liver failure and facilitate recovery from liver failure, support liver regeneration, and help
keep liver failure patients alive until an organ becomes available for transplantation.
“We are extremely excited to be able to offer our critically ill liver patients an intervention which may serve as a bridge
and improve their condition until they are transplanted,” says Santiago Munoz, MD, FACP, Chairman, Division of Hepatology,
Director, Einstein Center for Liver Disease, and one of the lead investigators for the clinical trial. “Our first patient
responded well to the device.”
The device is designed for use with a standard hemofiltration system but uses a cartridge containing hollow fibers with unique
permeability characteristics. When a patient’s blood is pumped through these fibers, the blood is cleansed of impurities
and toxins that accumulate in liver failure. The device was developed by Arbios Systems, Inc.
The clinical trial will assess if the liver device can keep patients with liver failure healthier and in better condition
until they undergo a transplant or their liver regenerates and recovers function. Currently, there is no therapy available
for patients in liver failure, other than maintenance and monitoring of vital functions and keeping patients stable. The hope
is that the patient’s liver will regenerate on its own. In many cases though, as a chronic liver patient’s disease progresses,
more and more liver function is lost and the patient ultimately needs to undergo liver transplant surgery.
Chronic liver disease is one of the leading causes of death in the general population. Liver failure affects all age groups
and may be due to many causes, including viral infection (hepatitis B, C, or other viruses), ingestion of common medications,
excessive alcohol consumption, and aggressive forms of fatty liver disease which cause cirrhosis. Liver failure typically
develops slowly, over years, and its progression usually goes unnoticed until it becomes life-threatening.
Einstein Center for Liver Disease and Transplantation has a multi-disciplinary team of specialists dedicated exclusively to
the diagnosis and treatment of liver disorders. It is one of the largest liver transplant programs in the Philadelphia region,
with patient outcomes above the national average. For more information on the liver assist clinical trial, please call 1-800-EINSTEIN.
CONTACT: Judy Horwitz
Communications Specialist
Albert Einstein Healthcare Network
215-456-6730
horwitzj@einstein.edu
Publish date: December 6, 2005
