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Pittsburgh researchers begin clinical trial with VitaGen bio-artificial liver assist device.

University of Pittsburgh researchers announced they 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, Inc., La Jolla, CA, is being studied at UPMC as part of a multi-center clinical trial. It is the only device being tested that involved continuous treatment, 24-hours-a-day for up to 10 days, according to UPMC.

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 4 in adults, and higher ultrafiltrate flows.

UPMC says the device has been used in trials in both the US and UK. The current trial is a Phase I/II study involving 6 centers. Safety as well as some efficacy measures will be examined. In addition, researchers will do a cost analysis, which could influence insurance reimbursement for the therapy should it eventually be approved by the FDA.

Initially the VitaGen study is only open to adults. It is expected that a protocol for children will be initiated later in 2000.

Contact: Lisa Rossi - (412) 624-2607, e-mail: rossiL@msx.upmc.edu
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Title Annotation:Product Information
Comment:Pittsburgh researchers begin clinical trial with VitaGen bio-artificial liver assist device.(Product Information)
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Jun 30, 2000
Words:257
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