Artificial Liver Succeeds in Trial - But money for development lacking, researchers say15 years, 4 months ago
Posted on Apr 21, 2004, 8 p.m.
By Bill Freeman
By Ed EdelsonHealthDay Reporter THURSDAY, April 22 (HealthDayNews) -- A "bioartificial" liver can save the lives of some patients with the worst kind of liver failure, researchers report. The device won't be available for medical practices for some time, however, because the money needed to run the trials necessary for government approval isn't there just now.
By Ed Edelson
THURSDAY, April 22 (HealthDayNews) -- A "bioartificial" liver can save the lives of some patients with the worst kind of liver failure, researchers report.
The device won't be available for medical practices for some time, however, because the money needed to run the trials necessary for government approval isn't there just now.
The device, which uses pig cells to perform the blood-cleansing function of the human liver, was developed by Dr. Achilles A. Demetriou, chairman of surgery at Cedars-Sinai Medical Center in Los Angeles.
The study of 171 liver failure patients at 20 medical centers found the device improved the survival rate by 20 percent or more, says a report in the May issue of the Annals of Surgery.
The U.S. Food and Drug Administration would require another successful trial before giving approval for use of the device in medical practice, and Circe Biomedical Inc., the company that paid for the first study, has folded, said Dr. Robert S. Brown, director of the center for liver disease and transplant tissue at Columbia Presbyterian Medical Center in New York City, a participant in the trial.
"These trials are very expensive, and the company is bankrupt," Brown said.
A successor company, Arbios Technologies Inc., is trying to raise money for a second trial, Demetriou said. He is a co-founder of Arbios, and owns 19 percent of the shares in the company.
Acute liver failure has a number of possible causes, including poisoning, drug overdoses, metabolic disorders and infectious hepatitis. Few patients survive the resulting buildup of fluid in the brain, major bacterial infections, respiratory problems and other complications that follow liver failure. For most patients, the only lifesaving treatment is a liver transplant.
The study followed 147 patients with initial liver failure and 24 whose liver failed after transplants. Of the 85 patients who had the bioartificial liver treatment, 71 survived for at least 30 days, compared to 62 percent getting conventional treatment, a 20 percent difference. For patients with initial liver failure, the bioartificial liver provided a 44 percent reduction in deaths.
"With a 20 percent improvement in survival, if this was oncology, we would be jumping up and down," Brown said.
And one of his patients, a woman who was so sick she could not have a transplant and "looked certain to die," recovered completely after the artificial liver treatment and now is "completely normal," he added.
Similar stories have come out of other centers in the trial, Demetriou said. "We developed this to give temporary support to the liver, with the idea that this would be a bridge to a transplant," he said. "Now it appears that there are a small number of patients who end up recovering."
Demetriou started working on new treatments for liver failure in 1976 at the National Institutes of Health. He worked on the bioartificial liver at Vanderbilt and continued that work when he went to Cedars-Sinai in 1992 to start the first unit devoted to managing massive liver failure.
While the effort to raise money for another trial goes on, "we are putting all our energy into developing an improved next-generation device," Demetriou said. "As soon as our studies are finished, we will be using that next-generation device on patients, hopefully in the next year or two."
The need to seek commercial funding for the device shows a flaw in the government's medical research program, Brown said. Funding is available for "orphan drugs" for patients with relatively uncommon diseases, but not for similar medical devices, he said.
"There is no money for promising therapies for which a market is not adequate to support a commercial effort," he said.
Demetriou is more upbeat about the future of his next-generation artificial liver.
"My expectation is that in the next few years, there will be a product approved," he said.
SOURCES: Achilles A. Demetriou, M.D., Ph.D, chairman, surgery, Cedars-Sinai Medical Center, Los Angeles; Robert S. Brown, director, center for liver disease and tissue transplant, Columbia Presbyterian Medical Center, New York City; May 2004 Annals of Surgery