July 31, 1998 Researchers at the University of North Carolina at Chapel Hill are the first on the East Coast to test the safety and efficacy of a bioartificial liver.
Just days after Circe Biomedical announced that the U.S. Food and Drug Administration had approved phase II/III clinical trials for its bioartificial liver support system HepatAssist(TM), UNC enrolled its first patient in the study.
"The patient was referred to us by Dr. John Gilliam at Wake Forest University Baptist Medical Center," said Dr. Jeffrey Fair, assistant professor of surgery and principal investigator at UNC. "He did an excellent job assessing the patient, determining that she would be a good candidate for this study, and then educating her family about this clinical trial."
The patient, a 45-year-old woman from Winston-Salem, NC, is the first person east of the Mississippi to receive HepatAssist(TM)therapy and the third person in the United States to be enrolled in this phase II/III clinical trial.
"I had just received a letter from UNC about this study," explained gastroenterologist Dr. John H. Gilliam III. "I was glad to hear that someone in the state has a bioartificial liver because it's very badly needed." Currently, UNC is the only center in North Carolina with access to this technology and the only institution on the East Coast participating in this pivotal trial; additional centers in the region may soon be enrolled.
The HepatAssist(TM)liver support system is designed to temporarily provide essential liver function for patients with acute liver failure. The primary goal of this study is to determine whether the HepatAssist(TM)liver support system provides a "bridge" to liver transplant or to regeneration and recovery.
The HepatAssist(TM)liver support system may increase the survival rate of patients waiting for a liver transplant by extending the "bridge" time until an organ match can be found, improve survival rate after transplantation, or support non-transplant candidates until their own liver can regenerate and heal.
Another goal is to compare the effects of standard surgical intensive care with daily bioartificial liver support treatments to standard surgical intensive care alone.
"All patients with acute liver failure who are admitted to the surgical intensive care unit at UNC will be screened for entry into this study," said Fair, who is also the surgical director of the abdominal transplant program in the UNC Comprehensive Transplant Center. "Those meeting the eligibility criteria and accepted into the study will then be randomly assigned to one of two groups ? either the group that receives standard surgical intensive care with daily HepatAssist(TM)treatments or the group that receives standard surgical intensive care alone."
"When we called about enrolling this patient in the study, we didn't know which group she would be assigned to," said clinical trial coordinator Jane Salm. "We were very excited when she was assigned to the group to receive the HepatAssist(TM) treatment." Salm added that it is the collaborative and multidisciplinary effort of many physicians, nurses, and lab technicians that makes it possible for UNC to provide its patients with this kind of treatment.
The HepatAssist(TM)liver support system is an extracorporeal treatment which resembles a dialysis machine. During treatment, the patient's plasma is circulated through a cartridge containing thousands of hollow fiber membranes surrounded by living, sterile pig liver cells (hepatocytes). The patient's own plasma cells may be detoxified by oxygen-rich hepatocytes, which are capable of performing many of the metabolic functions of a healthy liver. One treatment session lasts seven hours; treatments can be administered at eight hour intervals for up to 14 days.
Fair estimates that 30 patients from UNC will participate in this phase II/III clinical trial over the next year. Other UNC researchers involved in this study include Drs. David Gerber and Mark Johnson, both assistant professors of surgery, and Steven Zacks, clinical assistant professor of medicine.
In addition to UNC, other U.S. sites participating include: Cedars-Sinai Medical Center in Los Angeles; Mayo Clinic in Rochester, MN; Oregon Health Sciences Center in Portland; Rush-Presbyterian Medical Center in Chicago; University of Alabama at Birmingham Medical Center; University of California at San Francisco Medical Center; and University of Colorado Health Services Center in Denver.
Each year, more than 40,000 people die from liver disease. In 1997, approximately 4,100 patients underwent liver transplantation while an estimated 1,000 died awaiting a donor organ. Currently, there are more than 10,000 patients on the liver transplant waiting list.
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