Vital Therapies, Inc (VTI), announced that the first subject has been enrolled in a pivotal trial of its ELAD human cell-based liver assist system at California Pacific Medical Center (CPMC) in San Francisco. Todd Frederick, director of Liver Support Services, is the principal investigator for the trial at CPMC.
It is anticipated that up to 20 leading academic liver centers in the United States and Europe will take part in the SILVER (Stabilization In LiVER disease) study. The SILVER protocol allows for enrolment of patients with chronic liver disease who have recently suffered an acute event leading to moderate to severe liver failure, as measured by the Model for End Stage Liver Disease score (MELD). MELD score is widely accepted as an indicator of liver function.
The SILVER Trial is focusing on stabilization of liver disease so patients can either recover with their own liver intact or live long enough for a liver transplant. Liver transplantation is the only therapy proven to affect survival of liver failure patients. However the shortage of donor livers and the high cost of transplantation create a need either to support regeneration of the patient's own liver or to maintain sufficient liver function until a transplant organ becomes available. This study evaluates whether ELAD can provide this support.
More than 120 patients have so far been treated with ELAD in six clinical trials in the United States, United Kingdom and China. An application for approval to market ELAD in China was filed in September 2007 after a pivotal clinical trial in China. This application is under review by China's SFDA.
VTI is also operating a compassionate use program with cost recovery in the United States, United Kingdom and Singapore.
Vital Therapies is a privately held, venture backed company, with cell culture facilities in San Diego, California and a wholly owned subsidiary in Beijing, China.
California Pacific Medical Center is one of the largest private, community based, not-for-profit, teaching medical centers in California and is a Sutter Health affiliate.