Bioartificial Human Liver Therapy Trial Progressing
Vital Therapies Enrolls First Patients in Expansion of its U.S. Clinical Trial in Europe
Vital Therapies, Inc. (VTI) announced that the first two subjects have been enrolled at King's College Hospital in London in the expansion of its silver (Stabilization In LiVER failure) clinical trial in Europe. The trial is evaluating whether VTI's biological cellular therapy product, ELAD(R), can prevent deterioration of liver function and improve the survival of patients with acute-on-chronic liver failure (ACLF).
The SILVER trial is an open label, multi center, controlled, randomized trial. To date, 29 subjects have been enrolled at 11 U.S. sites and one U.K. site at King's College Hospital, a major European centre for the treatment of complex liver disease. Several other sites will soon be open for enrollment in the U.K.,Denmark and Saudi Arabia. More than 20 sites should eventually enroll a total of 80 or more patients in a 1:1 treated-to-control ratio. If successful, the resulting data will provide the basis for a Biological License Application (BLA) in the U.S., a Marketing Approval Application (MAA) in Europe, and a marketing approval application in Saudi Arabia.
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 (acute-on-chronic liver failure, ACLF). The trial is designed to explore whether the use of ELAD in this setting can prevent continued deterioration of liver function, called progression, and thus improve survival. The trial design uses a well-established measure of liver function called the MELD score to define the status of liver function. Treatment with ELAD, along with standard of care, is compared with standard of care alone. The time to either death or deterioration of liver function by a prespecified amount is measured. It is postulated that the use of ELAD may extend the time to progression and improve survival in this rapidly progressing patient population.
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 several leading cell experts. The cells are stable, immortal, can be grown in unlimited quantities and retain their hepatocyte (liver cell) characteristics. About 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.
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