Device Uses Human Liver Cells to Assist Organ's Functions
Acute Liver Failure (ALF) Patients Treated as Part of Ongoing Clinical Trials at NewYork-Presbyterian Hospital/Columbia University Medical Center
May 26, 2009
The first artificial organ for liver patients that uses immortalized human liver cells, the Extracorporeal Liver Assist Device, or ELAD®, is a bedside system that treats blood plasma, metabolizing toxins and synthesizing proteins just like a real liver does.
NewYork-Presbyterian Hospital/Columbia University Medical Center is currently one of only a small number of hospitals in the U.S. offering this therapy to acute liver failure patients as part of ongoing clinical
"These studies are looking at how well the system can extend patients' lives until a liver transplant becomes available. We're also interested to see if it can relieve the burden on the patient's liver enough so that it can regenerate and regain some of its function," says Dr. Robert Brown, site principal investigator, chief of the Division of Abdominal Organ Transplantation, and director of the Center for Liver Disease and Transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center. Dr. Brown is also the Frank Cardile Professor of Medicine and Pediatrics (in Surgery) at Columbia University College of Physicians and Surgeons.
The ongoing studies look at whether ELAD liver support improves survival compared with standard medical therapy. Patients are randomly assigned to receive either standard medical therapy plus the ELAD system, or standard medical therapy alone. Patients eligible for the study have life-threatening acute liver failure, often due to an infection. Another trial open to patients with liver failure due to drug overdose without underlying liver disease is expected to begin enrollment later this year.
The current trials expand on prior results from Phase 1 and 2 trials in the U.S. and U.K., and a pivotal, randomized, controlled clinical trial at two sites in China during 2006 and 2007. In the latter study, 69 patients with hepatitis B or C who had suffered ALF were treated with either ELAD or standard therapy. Thirty-day transplant-free survival rates were statistically higher in the ELAD group compared with the control.
Artificial livers have been attempted since the 1960s. Because previous designs didn't use human liver cells, they couldn't adequately filter toxins or create chemicals essential to metabolism and blood-clotting.
With the ELAD system, four 12-inch cartridges containing cells derived from human liver cells and fibers are mounted on a standard blood-pumping unit. The patient's blood plasma flows inside of hollow fibers to allow appropriate two-way transfer of metabolites across the fiber membrane.
Liver transplantation is limited by the supply of donor livers. According to the United Network for Organ Sharing (UNOS), there were approximately 6,500 liver transplants performed in 2007; however, there are more than 16,000 patients on the waiting list. Each year only about one-third of those who need a donor liver will receive one, and many patients die while waiting.
Acute liver failure afflicts more than 30,000 Americans each year, including those with chronic liver diseases like hepatitis, as well as those whose livers were damaged, such as by taking too much acetaminophen pain medicine. If not treated effectively and promptly — usually by transplantation — patients experience organ failure, bleeding, coma and death. When a donor organ isn't available or if the patient is too sick for surgery, ELAD could be their only option.
ELAD is manufactured by Vital Therapies Inc. of San Diego, sponsors of the current clinical trial.
For more information, patients may call 866-NYP-NEWS.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The Medical Center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians and Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit www.cumc.columbia.edu.
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments — more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/The Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons.