A phase II/III clinical trial testing a new bioartificial liver in patients with acute liver failure who are awaiting a liver transplant is being launched at a number of centers in the United States and Europe.
The trial is being initiated following Food and Drug Administration approval for Circe Biomedical of Lexington, Mass., to test its HepatAssist Liver Support System at leading liver transplant centers. The system "combines highly refined, live pig liver cells with a sophisticated membrane system that may temporarily provide a patient with essential liver functions," according to Rush-Presbyterian-St. Luke's Medical Center of Chicago, one of the centers participating in the trial. While the system is designed as a bridge to transplantation, it also may allow enough time for a patient's own liver to recover without transplantation.
"This new system holds the promise of buying extra time for a suitable donor liver to be found," said Lawrence P. McChesney, MD, one of the principal investigators at Rush.
"The technology is the most advanced of its kind in the world," said Achilles Demetriou, MD, PhD, director of the liver support unit at Cedars-Sinai Medical Center in Los Angeles.
The pig liver cells used in the system are subject to extensive testing to exclude viruses, bacteria, and other organisms. The liver cells are then frozen, can be stored for up to three years, and can be thawed and prepared for use in two hours.
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