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University of Pittsburgh Begins Trial with New Bio-Artificial Liver Device

PITTSBURGH, June 22, 2000 — University of Pittsburgh researchers have initiated a clinical study of a bio-artificial liver assist device that is intended to support patients with acute liver failure until human organs can be found for transplantation or until a patient's own liver function improves.

The device, developed by VitaGen Incorporated of La Jolla, Calif., is being studied at UPMC Presbyterian as part of a multi-center clinical trial. It is the only device that involves continuous treatment, 24 hours a day for up to 10 days.

Nearly 15,000 people await life-saving liver transplants. Due to a long-standing shortage of donated organs, many patients die on the waiting list. More than 1,300 needing liver transplants died in 1998, the most recent year such data are available. The sickest patients -- those with acute liver failure or acute complications of a chronic liver disease -- often do not survive the wait or become too sick to qualify for transplantation.

"From a critical care point of view, there may be a real advantage even if the liver assist device only slightly improves a patient's condition. If an organ becomes available for transplant, the outcome is likely to be better if the patient is stable prior to surgery. And if the liver function improves more dramatically, transplantation may not even be necessary," said David Kramer, M.D., associate professor of anesthesiology, medicine and surgery, and co-principal investigator of the VitaGen trial at the Pittsburgh site.

"There is a desperate need for a reliable means of support for patients who can't afford to wait for an available organ. The situation just seems to get worse and worse each year," said George Mazariegos, M.D., assistant professor of surgery at the Thomas E. Starzl Transplantation Institute and co-investigator with Dr. Kramer.

The Extracorporeal Liver Assist Device (ELAD) made by VitaGen pumps the patient's blood outside the body through a plasma filter and back into the patient. The ultrafiltrate is then pumped through hollow fiber cartridges that contain a patented human cell line that mimics certain characteristics of normal liver cells. The blood pump speed can be adjusted to maintain hemodynamic stability, while clearance of toxins may be increased by more cartridges, up to four in adults, and higher ultrafiltrate flows.

The device has been used in trials in both the United States and the United Kingdom. The current trial is a Phase I/II study involving six centers. Safety as well as some efficacy measures will be examined. In addition, researchers will do a cost analysis, which in the future could influence insurance reimbursement for the therapy if it is eventually approved by the U.S. Food and Drug Administration.

Patients with fulminant hepatic failure--which is acute failure with a sudden onset-- 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 for up to 10 days. ELAD support will be continued until successful liver transplantation or spontaneous recovery of liver function. Initially, the VitaGen study is open only to adults. It is expected that a protocol for children will be initiated later in the year.

UPMC's involvement with the VitaGen trial is part of its ongoing emphasis on basic and clinical research of liver support systems. Researchers at the Thomas E. Starzl Transplantation Institute have been working with Minnesota-based Excorp Medical, Inc., to develop a system that uses pig liver cells to filter toxins from the diseased liver. A handful of adults have undergone treatment with the system and it is expected to be used for the first time in children later this summer in a trial at Children's Hospital of Pittsburgh.

For more information about either device or to discuss adult patients with acute liver failure, please call UPMC at 412-692-2400 or 1-800-533-8762.

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