Artificial Liver Being Tested at University of Pittsburgh Used Successfully in Two Patients So Far

PITTSBURGH, February 3, 2003 As part of a national study, University of Pittsburgh Medical Center (UPMC) researchers used an experimental artificial liver assist system that helped stabilize two patients who were in acute liver failure and close to death until donor organs were available for transplantation. Both received successful transplants and are doing well.

One patient received a liver transplant and the second patient received a five-organ transplant that included the liver, small bowel, stomach, pancreas and duodenum. She is the first patient to be supported with the device for acute liver failure and then to receive a multivisceral transplant.

UPMC is one of 12 centers participating in a multi-center Phase II trial to evaluate the safety and effectiveness of the ELAD (Extracorporeal Liver Assist Device) Artificial Liver system developed by VitaGen Incorporated of La Jolla, Calif., to temporarily support patients in fulminant hepatic failure, acute liver failure that has a sudden onset.

The company hopes to enroll 30 patients in the study. Of 19 that have been enrolled so far, 13 have been supported with the device, say company officials.

UPMC participated in the company's Phase I trial as well. According to VitaGen, 12 of 15 (80 percent) of the ELAD-treated patients in that trial involving six centers had positive outcomes either they were successfully bridged to transplantation or their livers recovered and transplantation was not necessary. Five of nine (56 percent) of the control group patients, who received standard medical treatment for fulminant hepatic failure, were transplanted or recovered.

The ELAD is an external device that works in a similar fashion to kidney dialysis, whereby waste products are removed from the blood. A pump pushes the patient's blood through a catheter into a large filter that separates blood cells from plasma, creating what is called ultrafiltrate. The ultrafiltrate in turn passes through cartridges containing a cultured human cell line and is then returned through another catheter back to the patient.

It is hoped that the cells contained in the device may provide some of the vital functions that a normal, healthy liver does, such as metabolizing toxins and producing beneficial proteins.

Despite the best that medicine can offer, chances are not always good that patients in fulminant hepatic failure will survive even the shortest wait for donor organs. Having a means of temporary support for these patients could buy them precious time and may even allow their livers to recover, noted Peter Linden, M.D., D.M.D., associate professor of critical care medicine at the University of Pittsburgh School of Medicine , critical care director of the liver transplant intensive care units at the University of Pittsburgh Medical Center and principal investigator for the Pittsburgh study site.

Development of an artificial liver is a daunting challenge because of the many complex functions that the liver performs. But the need is urgent, as more than 2,000 patients needing liver transplants die on the national waiting list each year. This number could be reduced if we had an artificial liver to support some of these critically ill patients, added George V. Mazariegos, M.D., associate professor of surgery at the University of Pittsburgh's Thomas E. Starzl Transplantation Institute .

Of the more than 80,000 patients awaiting organ transplants in the United States, about 17,000 are in need of livers. At any given time, approximately 5 percent of these patients are patients in acute liver failure who are not expected to live beyond seven days without transplants.

Patients with fulminant hepatic failure who are eligible for the study will be randomized to undergo experimental treatment with the device in addition to standard treatment or to receive standard treatment alone. Patients randomized to the device will undergo experimental treatment 24 hours a day until successful liver transplantation or spontaneous recovery of liver function occurs. Treatment with the ELAD would not be expected to go beyond 10 days.