ROCHESTER, MINN. - Mayo Clinic is one of two medical centers in the Midwest, and the only center in Minnesota, to participate in clinical tests of a new device designed to keep liver transplant candidates alive until organs are available.
The device is a bioartificial liver support system similar to a kidney dialysis machine. The technology utilizes pig liver cells to process and metabolize waste products. Treatment allows the liver to rest, and in some cases, it reduces or even eliminates the need for transplantation.
With the help of the new bioartificial liver, principle investigator, Scott Nyberg, M.D., Ph.D., hopes Mayo Clinic can help more people get the transplants they need. "It can take seven to ten days for an organ to arrive, but patients with acute liver failure may only last two days," says Dr. Nyberg. "We hope this research will show whether or not this new technology can keep patients alive longer."
In addition to acting as a bridge for patients waiting for transplants, the device will support people who need a second transplant because the first one failed.
The new technology showed promising results in the first phase of tests conducted by Circe Biomedical, Inc. In the first phase of testing, 38 patients were treated successfully. Of that number, 32 were transplanted and six recovered without needing a transplant.
In this second phase of testing patients will be randomized so that half will use the device and half will receive standard intensive care. Patients involved in the study must meet certain criteria. They must have acute, sudden onset liver failure, and have no history of chronic liver disease.
Researchers are testing the device on patients who were healthy, and suddenly, within two months, developed severe liver failure due to causes including viral infection and drug toxicity.
Liver disease results in 40,000 deaths in the United States each year. Of those deaths, 1,400 patients die waiting for liver transplants, often because the organs are not available. Currently, there are 14,000 people on liver transplant waiting lists. Doctors perform approximately 4,000 liver transplants annually.
Dr. Nyberg says the study will evaluate survival and recovery rates of study participants. Thus far, three patients have been treated with the device at Mayo Clinic as part of the clinical trial.
It is estimated that 150 people will participate in the multi-center clinical trial over two years. The clinical trial includes ten sites in the United States, including Mayo Clinic in Rochester, Minnesota, and nine sites in Europe. The U.S. Food and Drug Administration is monitoring the research. The device was developed by Circe Biomedical, Inc., Lexington, Mass.
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