5 April 1999

First Artificial Liver Trial Using Human Cells

Doctors at the University of Chicago Hospitals are starting clinical testing of the worlds first artificial liver device that uses cells from humans rather than from pigs.

ELAD (Extracorporeal Liver Assist Device), is designed to serve as a temporary liver for patients with acute liver failure, keeping them alive until their own organ can either recover or another suitable transplant organ becomes available. The University of Chicago is the only hospital in the world currently able to offer this treatment and this study will be used to determine the safety and efficacy of the ELAD. According to Professor Michael Millis, "Several previous devices containing liver cells from pigs have produced encouraging results, but there has been a good deal of concern about exposing patients to animal cells, which may function slightly differently and could harbor infectious agents. This trial should determine whether a device that incorporates human cells rather than pig-liver cells can reduce those risks and perhaps function more like a normal human organ."

Another advantage of ELAD is that this device can be used continuously by changing the cartridges every few hours unlike other devices containing pig cells that can be used for no more than six to eight hours each day.

The primary goal of the artificial liver is to support the patient through a brief period of liver failure, protecting the brain and other organs for up to ten days, and giving the damaged liver time to recover without transplantation.

The secondary goal is to extend the patient's ability to wait for a suitable donor organ. Patients in complete liver failure have only a few days to wait before irreversible damage begins.

The artificial liver may also be used to support a patient after transplantation until the grafted liver begins functioning adequately and can fully sustain the patient.

"This device has the potential to reduce the need for liver transplants by giving acutely ill patients with limited liver damage time to recover," said Millis. "It could also open the window of opportunity a little wider for those who absolutely need a new organ to survive." The portable device uses a two-chambered, hollow-fiber cartridge filled with immortalized liver cells. The cell-filled cartridges, which can be installed in a standard kidney-dialysis machine

When attached to blood vessels in the groin, the device separates the plasma from the cellular components of the blood and pumps the patient's plasma through the filter cartridges. These cartridges bring the plasma in contact with millions of metabolically active liver cells which should function much like a normal liver. The treated plasma is then filtered, re-mixed with the cellular components of the blood, and returned to the patient.

Two previous uncontrolled trials, one in the United States and one in the United Kingdom, demonstrated the safety of an earlier version of this approach. The newer device has been enhanced to increase the liver cell mass and improve cell viability.

The trial will involve 24 patients. The first six to enter the study will receive standard therapy plus treatment with the ELAD. The next 18 patients will be divided randomly, nine to receive the treatment and nine to receive standard therapy.