A device that uses human liver cells may extend the lives of those awaiting a liver transplant and even allow the damaged liver to heal itself completely.
That could be good news for people suffering with hepatitis C, which is the primary cause of liver damage requiring liver transplants in the United States.
Set for phase II clinical tests, the extracorporeal liver assist device (ELAD) is the first to contain functioning human hepatocytes, liver cells that help sustain and support the work of the patient's damaged and failed organ. Other liver assist systems use hepatocytes from pigs.
Patients are tethered to the device by a catheter inserted into a vein in the neck. After the blood is initially filtered, the remaining plasma goes through cartridges in the ELAD where the human hepatocytes help fulfill much of the liver's crucial functions. The filtered blood and ELAD-treated plasma are returned to the patient.
Dr. Roshan Shrestha, associate professor of medicine and medical director of the liver transplantation program at the University of North Carolina, one of the test sites, said ELAD could serve as a bridge to successful transplantation and enable some patients to make a complete recovery.
"A remarkable feature of the liver is its capacity to regenerate," said Shrestha. "If we can sustain acute liver failure patients early on, right from the beginning, they may not need transplantation and may recover without any significant liver problems, including chronic liver disease."
Shrestha said a phase I clinical trial conducted in the United States and Great Britain in 1999 and 2000 found that 11 of 12 patients who received treatment with the new device achieved either a successful bridge to transplantation or full recovery.
Shrestha said the U.S. Food and Drug Administration was sufficiently pleased with the results to approve a phase II trial of between 30 to 40 people where the main endpoint is safety and effectiveness, including survival at 30 days. A phase III trial may follow with an enrollment of at least 200 people with acute liver failure.
"Currently, we don't have very good therapies for patients with acute liver failure. That's why we're hoping that the new technology will make a big difference," Shrestha said.
Other sources: University of North Carolina School of Medicine