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| http://www.einstein.edu/aboutus/new...ticle11592.html
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
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