Vital Therapies, Inc. ELAD Extracorporeal Liver Assist Device


	CLINICAL TRIALS

	Clinical Trials
	Clinical Advisory Board - USA
	Clinical Advisory Board - China
	Past Clinical Investigators

clinical trials

The ELAD^® System is regulated as a biologic by the CBER division of the FDA, assisted by CDRH.

Four clinical trials of the ELAD^® System have been conducted. Two initial trials were completed under an IDE from the US FDA, one at Baylor College of Medicine and the other at King’s College in London. A phase I trial and a phase II trial have been conducted under an IND from the US FDA at twelve different clinical sites in the US and UK.

A total of 52 patients have been treated with the ELAD^® System in the four studies. While the total number of critically ill patients treated with the product is relatively small the following observations can be made:

The product demonstrated safety.

Various clinical endpoints suggest a difference between the treated and control patients. There were a greater number and percentage of patients on the ELAD^® System therapy going on to transplant and fewer in which further treatment was deemed futile.

The investigators who participated in the Phase I and II trials are enthusiastic about the potential of the ELAD^® System and are anxious to participate in the next clinical trial.

VTI was recently invited to seek approval for ELAD^® in China by one of the leading liver disease hospitals in Beijing. Liver disease in China is a serious problem with over 150 million carriers of Hepatitis B/C virus, 25 million symptomatic patients and 400,000 deaths per year, as confirmed by a custom IMS market study. VTI is currently conducting a pivotal clinical trial in China which will be used to secure approval to market ELAD^® in China and to provide more safety data for US registration.