Liver-Assist Device Utilizes Human Liver Cells

A new system based on human liver cells can provide metabolic function and be a bridge to transplant or recovery for patients with severe liver failure.

The extracorporeal liver-assist device (ELAD) system, under development by Vital Therapies (San Diego, CA, USA), provides important metabolic support for patients with severe liver failure, thereby enabling a bridge to recovery or transplant depending on the type and severity of liver failure. The key to the performance of ELAD is its utilization of a proprietary human hepatocyte cell line, C3A, an immortalized cell line that can be grown, stored, and shipped worldwide.

The system is made up of four cartridges containing C3A cells that function like a normal human liver by metabolizing toxins and removing waste products while delivering essential proteins back into the plasma. These cartridges are incorporated into a blood-pumping system at the patient's bedside and enable continuous patient treatment for up to 12 days.

Vital Therapies announced that it has received guidance from the U.S. Food and Drug Administration (FDA) that will allow the company to begin shipment of the ELAD cartridges to China. Allowance to ship the cartridges was the final step required for pivotal clinical trials set to begin in China in early 2006. The company has already conducted Phase 1 and 2 clinical trials with ELAD in the United States and the United Kingdom.

"Liver disease is a major medical problem in China, and there's an overwhelming and unmet need for new therapies,” said Professor Duan Zhong-Ping, M.D., of the Beijing Artificial Liver Treatment & Training Center and vice president of the Beijing YouAn Hospital (Beijing, China). "I see many patients in our hospital every month whose lives are threatened by liver disease, and a good percentage of these patients die even with the mechanical artificial liver treatment available here today. We desperately need a new option.”




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