Doctors test latest attempt at artificial liver









"I'm just eternally grateful," she said.







There are nearly 28,000 deaths a year in the U.S. from liver disease, and fewer than 6,000 liver transplants. Eligible for the experiment are a subgroup: People with conditions slowly damaging their livers, such as hepatitis or cirrhosis, when something – an infection, often – abruptly pushes them over the edge into full-fledged liver failure. About half die.

The FDA is asking if three to 10 days of ELAD liver support improves 30-day survival over the similarly ill who get today's standard supportive care. Among the safety issues to get close scrutiny: The device's cells initially were derived from a liver tumor and are encased to ensure none of those cells enter a patient's body. Doctors also will ask if any benefit is big enough to cover what could be a $30,000 price tag.

Manufacturer Vital Therapies Inc. says that among the first 49 patients it studied in China, where liver failure is more rampant, 85 percent given ELAD therapy survived short-term compared with half of patients given regular care.

In the U.S., the study just began in October, too soon for any conclusions. But Michigan's Napolitano notes that kidney dialysis had a similarly rocky start in tests of the dying before doctors could determine how it best worked and use it on the less sick – an ultimate goal for whatever artificial liver scientists eventually develop.

"It's a challenging technology to test. It's a very challenging cohort of patients because they're so sick," agrees Dr. Winfred Williams of Massachusetts General Hospital. But he's testing ELAD again because of a 2002 patient, Kevin Fitzmaurice of Boston who started emerging from a five-day coma after a day of the liver-supporting therapy.

"The nurses fairly accosted me at the door to say he was waking up," Williams recalls, and a few days later Fitzmaurice was stable enough to transplant. "Had he not gotten onto the ELAD support, he would not have survived."

Now 55, Fitzmaurice says his donated liver is doing great.

