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Please Note: The technology listed below is not available to the public at this time. This technology is in the early stage of research and requires further development before it is ready for the marketplace. The VA is currently in the process of identifying potential companies who may be interested in licensing and/or further developing the technology through Cooperative Research and Development Agreements (CRADA). Through cooperative research initiatives such as these, it is our hope and goal that commercial products will be fully developed and made available to benefit veterans and others.  

VA TECHNOLOGY OPPORTUNITY BRIEF

Method for Identifying Preferred Liver-Transplant Donors

(#00-070)

OPPORTUNITY:
The Department of Veterans Affairs (VA) is seeking a commercial partner to license or further develop this technology through a Cooperative Research and Development Agreement (CRADA) to expedite bringing it to market.

BACKGROUND:
Approximately 5,000 liver transplants are performed each year, and it is estimated that nearly 1,700 prospective transplant recipients died in 2001 while waiting for a liver for transplantation. Currently more than 18,000 people are waiting for a liver transplant.  

The number of organ transplants in the United States increased 5.4 percent from 1999 to 2000, according to the Transplant News Network. Part of this increase is attributable to liver transplants, the need for which is expected to be driven primarily by the growing number of cases of hepatitis C. The Centers for Disease Control and Prevention estimates that 3.9 million Americans have been infected with the hepatitis C virus (HCV) and that 2.7 million of them are chronically infected. With thousands of liver transplants performed annually in the United States, identifying predictors of poor outcome will likely have great clinical implications. 

As the demand for donor organs continues to grow faster than the supply, it is critical to optimize survival results following transplantation. Although several studies of transplant recipients have identified specific factors associated with a poor outcome, it is unknown to what extent genetic differences in donor organs contribute to a poor outcome. Therefore, a genetic-based method is needed to identify preferred transplant donors whose livers will increase the likelihood of a successful outcome. 

TECHNOLOGY OVERVIEW:
Following liver transplantation, a number of factors play a role in determining the long-term success of the operation. One of the greatest challenges to a patient's long-term survival is the recurrence of underlying diseases. Hepatitis C-related liver failure is the leading complication for liver transplant recipients, and the majority of them will develop some evidence of recurrent hepatitis C in their new livers.  

The VA has identified a genetic-based method for determining predictors of poor outcomes of liver transplantations. The agency discovered that the genetic makeup of the donor liver, by virtue of the nature and magnitude of its response to recurrent infection, predicts the outcome of a transplant operation. Specifically, the VA learned that if a patient receives a liver expressing a single mutation with a gene, which encodes an inflammatory factor (TNF), a variant found in approximately 20 percent to 25 percent of the general population, the likelihood of that patient developing severe recurrent hepatitis C infection is greater than 50 percent. This finding might influence donor selection and help identify patients who might benefit from alternative approaches. 

TECHNICAL MERIT:
The VA study was the first to demonstrate that patients receiving a donor organ expressing the non-wild type allele for the tumor-necrosis factor gene had a significantly greater chance of developing severe recurrence of hepatitis C infection within their allografts.  

PATENT STATUS:
Federal Register: August 31, 2001 (Vol. 66, No. 170) p. 46065
US patent issued on January 18, 2005 (6,844,156)

FOR MORE INFORMATION CONTACT:
Saleem Sheredos
Program Manager
Technology Transfer Program
Veterans Affairs
Office of Research & Development (12TT)
5th Floor
103 South Gay Street
Baltimore, MD 21202
202-380-5080
Fax 410.962.2141
e-mail: saleem.sheredos@va.gov
Last Updated - Wednesday, July 18, 2007 8:55 AM