Cedars-Sinai physicians and scientists are testing a novel, human cell based, bioartificial liver support system for patients with acute liver failure, often a fatal diagnosis.
"The quest for a device that can fill in for the function of the liver, at least temporarily, has been underway for decades. A bioartificial liver, also known as a BAL, could potentially sustain patients with acute liver failure until their own livers self-repair," said Steven D. Colquhoun, MD, the surgical director of liver transplantation at Cedars-Sinai's Comprehensive Transplant Center.
Colquhoun is leading an investigation at Cedars-Sinai to assess the safety and effectiveness of the ELAD® bioartificial liver system, which is designed by Vital Therapies Inc., the sponsor of the clinical trials. The majority of the 49 sites currently involved in the investigation are in the United States, but studies are also underway in Europe and Australia. The research at Cedars-Sinai involves patients with liver disease caused by acute alcoholic hepatitis, a group with few therapeutic options.
In the bioartificial liver under investigation, blood is drawn from the patient via a central venous line, and then is filtered through a component system featuring four tubes, each about 1 foot long, which are embedded with liver cells. The external organ support system is designed to perform critical functions of a normal liver, including protein synthesis and the processing and cleaning of a patient's blood. The filtered and treated blood is then returned to the patient through the central line.
"If successful, a bioartificial liver could not only allow time for a patient's own damaged organ to regenerate, but also promote that regeneration. In the case of chronic liver failure, it also potentially could support some patients through the long wait for a liver transplant," said Colquhoun.
The functions of the liver are very complex. The 3-pound organ that sits to the right of the stomach performs many functions including detoxification, regulation of glucose levels and the making of vital proteins. Liver failure can be caused by trauma, such as an accident, by viral infections, overdosing on drugs - including some over-the-counter pain medications -- and from alcohol abuse. Liver failure is often life-threatening in a matter of days.
Devices that do the work of human organs have been used successfully for years. Patients with kidney disease can use dialysis, and those with cardiac problems have ventricular assist devices or artificial hearts available to support or replace vital organ functions.
"Liver failure patients and their doctors have long been frustrated by the critical need to provide the kind of life-saving care kidney patients are afforded by dialysis. This important investigation we are undertaking at Cedars-Sinai is a critical step in addressing the medical emergency presented by liver failure," said Andrew S. Klein MD, MBA, director of the Comprehensive Transplant Center and the Esther and Mark Schulman Chair in Surgery and Transplantation Medicine.
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