October 4 , 2002

Four days before he was to celebrate his 49th birthday, Kevin Fitzmaurice was brought to the MGH Emergency Department with acute liver failure. Usually patients with this condition have few options for survival except liver transplantation, but receiving an organ can take weeks – if an organ becomes available at all. While in a coma, Fitzmaurice was evaluated by Winfred Williams, MD, director of the MGH Interventional Nephrology Renal and Transplantation Units. Williams approached the family about enrolling Fitzmaurice as a clinical trial candidate for a new liver support system. Soon, Fitzmaurice became the first person in New England to be treated with a revolutionary artificial liver machine that kept him alive for two days while he waited for a liver transplant.

The ELAD (extracorporeal liver-assist device) is a machine designed to support a patient with acute liver failure 24 hours a day for up to 10 days while the patient waits for an organ to become available or while the liver regenerates. ELAD is manufactured by VitaGen Inc. and is being tested in a clinical trial at the MGH and five other U.S. hospitals.The MGH trial is under the direction of Williams. Within hours of being placed on the machine, Fitzmaurice became more responsive and alert. Two days later an organ became available, and a liver transplantation was successfully completed. "It's remarkable. I thank God every day," said Fitzmaurice at an MGH press conference Sept. 26. "I feel like I have been given a new lease on life."

Based on the same technology used in the kidney dialysis machine, the ELAD features two-chambered, hollow-fiber cartridges containing immortalized human liver cells, which are grown from a cell line owned by VitaGen. The patient's blood is pumped through the device, and the plasma is separated out and passed through the cartridges in which liver function is carried out. The treated blood then is returned to the patient.

"The clear improvement in Mr. Fitzmaurice's clinical status happened quickly, bringing him back from a state of virtual coma," said Williams. "It truly was remarkable and exceeded even my own expectations."

Fitzmaurice is the 14th person to have successfully been treated by ELAD; 11 patients were treated in the initial Phase 1 trial and 3 in the current Phase 2 trial.

"To me, the ELAD represents the most significant advance in a quest for a liver dialysis machine in my 30 years of practice," said Benedict Cosimi, MD, chief of MGH Transplant Surgery, who performed Fitzmaurice's transplant. "I was skeptical, but pleasantly surprised at how well Kevin responded to the ELAD machine."

According to the United Network for Organ Sharing, approximately 21,000 patients in the United States currently are waiting for a liver transplant. Each year, approximately 2,000 Americans die waiting for a liver to become available.

Fitzmaurice, left, with Williams and ELAD machine.