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Temple University Hospital Using Investigational "Bio-Artificial" Liver

Temple University Hospital is the first in Philadelphia, and the tri-state region, to use an investigational "bio-artificial" liver that can potentially replicate the organ's complex functions by passing a patient's blood through an external device containing live liver cells.

The investigational device, called an ELAD (Extracorporeal Liver Assist Device)®, may help patients with liver failure become healthy enough for transplant, or, possibly, extend the lives of those who aren't able to receive a transplant.

Temple successfully used the "bio-artificial" liver on a female patient on Sunday, February 7, according to Santiago J. Munoz, MD, Medical Director of Temple University Hospital's Liver Transplantation Program and the site's Principal Investigator for the Phase II/III clinical trial (Temple IRB# 12662). 

If proven successful, ELAD® therapy can help doctors address one of the main challenges of liver failure – keeping the patient healthy enough to undergo transplant surgery until a compatible donor organ can be found. In cases where the liver damage is less severe, the hope is that an ELAD® intervention may be able to take some of the load off the liver, enabling it to regenerate on its own.

Unlike kidney failure, in which patients can maintain organ function through dialysis, no comparable intervention has been successfully developed for the liver because of the complex series of functions the organ carries out.

"The idea behind the ELAD® has existed for more than two decades," said  Munoz. "Earlier devices did little more than pass blood through a filter, which, at most, could only attempt to clean the blood. For the first time, new technology allows us to use actual living cells to not only remove toxins, but also perform higher liver functions such as the synthesis of proteins."

The ELAD® is connected to a patient via a major blood vessel, such as the femoral vein in the leg or the jugular vein in the neck. Blood is processed through a series of four cartridges containing about a pound (15.455 oz./440 grams) of human liver cells, which can perform the liver's intricate functions outside the patient's body.

The liver is the body's main processing center. Its principal functions include converting food into energy, producing thousands of essential proteins, and cleansing the blood of toxins.

The ELAD's® specialized cells were originally harvested from a liver cancer tumor, because, unlike ordinary liver cells, these "immortal cells" have the ability to reproduce indefinitely while still retaining their functionality. The cells are shielded from the patient by a series of membrane filters, which have been designed to allow only the patient's blood and liver by-products to pass through.

Temple is one of 17 sites in the United States actively enrolling patients in this clinical trial – and one of only two in the tri-state area to participate.

The ELAD® trial is being sponsored by Vital Therapies, Inc., the private company that also developed the proprietary ELAD® technology.

For more information about the ELAD® trial, please call (215) 707-6644.

Date Published: Tuesday, March 23, 2010

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