Pittsburgh researchers begin clinical trial with VitaGen bio-artificial liver assist device.
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)|
|Article Type:||Brief Article|
|Date:||Jun 30, 2000|
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