PITTSBURGH, April 23 -- Preliminary results of a new bio-artificial liver assist device were presented by University of Pittsburgh Medical Center (UPMC) researchers today at the 44th annual American Society for Artificial Internal Organs (ASAIO) conference in New York City. The device, designed by Excorp Medical Inc., significantly improved liver failure in animal studies, and researchers anticipate their results will help secure approval to begin studies in humans soon.
The researchers are awaiting U.S. Food and Drug Administration (FDA) approval to allow further testing in humans as a phase I clinical trial which will evaluate whether the device is safe.
The Excorp bio-artificial liver assist device is intended to provide temporary support to patients with acute liver failure until their liver recovers spontaneously or until transplantation is possible. When human trials begin, researchers will place patients with acute liver failure on the device, which is connected to a vein and remains outside their bodies. Researchers believe it should help remove toxins from the patient's own liver cells, as the patient's blood circulates in a chamber with pig liver cells inside polymer membranes. The membranes allow toxins to pass through, but prevents proteins, and other cell byproducts from the pig cells to get into the patient's blood.
"Initially, the agreement between UPMC and Excorp allowed researchers to gather engineering and pre-clinical information about the device," said Jack Patzer, Ph.D., assistant professor of surgery and chemical engineering at the University of Pittsburgh, who presented the findings at the ASAIO meeting.
"But with the bio-artificial liver assist device demonstrating such a
significant impact on the course of liver failure in our animal trials, we hope
within the month to secure FDA
approval to begin phase I human t
Contact: Lisa Rossi
University of Pittsburgh Medical Center