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.

 

 

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