PHILADELPHIA, Dec. 6 /PRNewswire/ -- 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(TM) 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.
(Photo: http://www.newscom.com/cgi-bin/prnh/20051206/PHTU003 )
“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.
Background Information Liver Disease * Chronic liver disease is the 10th leading cause of death in the United States. * An estimated 25 million Americans have liver-related diseases. * Of the 17,500 U.S. patients on the liver transplant list, nearly 2,000 die each year due to a shortage of suitable liver donors; and less than 5,000 people receive a transplant. Source: Arbios Systems, Inc. Santiago Munoz, MD, FACP
Santiago Munoz, MD, FACP, is a nationally renowned liver disease expert who has a special interest in chronic virus hepatitis, autoimmune hepatitis, biliary cirrhosis, hemochromatosis, Wilson’s disease, and other liver disorders. Dr. Munoz is actively engaged in clinical studies and research projects for chronic hepatitis C virus. In addition, he is principal investigator of a National Institutes of Health grant for the study of acute liver failure. He is board certified in internal medicine and gastroenterology.
Dr. Munoz joined Albert Einstein Medical Center in 1995 as Director, Einstein Center for Liver Disease, and Medical Director of the Liver Transplant Program. In 1997, he was appointed Head of the Division of Hepatology. Dr. Munoz serves as Associate Professor of Medicine at Temple University School of Medicine.
Albert Einstein Medical Center
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CONTACT: Judy Horwitz, Communications Specialist, Albert EinsteinHealthcare Network, +1-215-456-6730, horwitzj@einstein.edu
Web site: http://www.einstein.edu/
