The trial is evaluating whether VTI's biological cellular therapy product, ELAD®, can prevent deterioration of liver function and improve the survival of patients with acute-on-chronic liver failure.

If successful, the resulting data will provide the basis for a Biological License Application in the USA, a Marketing Approval Application in Europe and a marketing approval application in Saudi Arabia. For a full listing of clinical trial sites and further information on the trial, please go to www.clinicaltrials.gov.

The SILVER protocol enrolls subjects with chronic liver disease who have been hospitalized as a result of an event, such as an infection or an episode of bleeding, which has caused deterioration of their liver function (i.e. acute-on-chronic liver failure). The trial is designed to explore whether the use of ELAD in this setting can prevent continued deterioration of liver function and improve survival.

ELAD is a biologic liver support system using a proprietary line of allogeneic human liver cells originally derived from a human liver tumor and refined by cell experts. The cells are stable and immortal, can be grown in unlimited quantities and retain their hepatocyte (liver cell) characteristics.

Approximately one pound of cells is used for each treatment. The cells are grown in specially designed cartridges at VTI's plant in San Diego, transported to the hospital and used to treat the patient's plasma outside the body for up to ten days.