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The DIALIVE device will be used to help patients with a severe liver condition called acute-on-chronic liver failure (ACLF). The condition often causes multi-organ failure, and many patients don’t survive.
DIALIVE works by removing toxins from patients’ blood and by exchanging ‘dysfunctional’ albumin for healthy albumin. This allows the patient time for their liver to recover and regenerate so it can start functioning on its own.
A previous Europe-wide study showed the device is safe and offered benefit. The study indicated that for those treated with DIALIVE, ACLF was resolved approximately twice as frequently and, significantly, more rapidly than those on standard treatments.
Globally ACLF affects up to 3.7 million patients with liver cirrhosis (scarring) each year, including around 1.9m patients where the disease has progressed even further. Depending on severity, about 40 - 80% of patients die within 28 days.
The trial will recruit about 70 of the sickest patients – those with multiple organ failure following liver disease and who have a high risk (between 40 - 80%) of dying unless they receive a liver transplant.
Those patients selected at random to receive DIALIVE will receive up to seven sessions of treatment over a ten-day period.
Leading the study as co-principal investigators are Prof Banwari Agarwal and Dr Rohit Saha at the RFH.
Dr Rohit Saha said: "This trial has the potential to be life-changing for hundreds of thousands of patients with acute-on-chronic liver failure. If successful, we will transform the way we manage liver failure globally."
Professor Rajiv Jalan, based at UCL and RFH, who co-invented the DIALIVE device, said: “This is extremely important news for patients within the UK and beyond with ACLF whose current treatment options are severely limited.
“Our goal is to demonstrate that we can resolve ACLF more often and/or faster than standard of care, and thereby improve a patient’s chances of survival and reduce their time in hospital.”
A £2.2 million clinical research grant from the National Institute of Health and Care Research (NIHR) will fund the trial, which will take place across in more than 10 hospitals in the UK. The results are expected in 2027. Once the trial concludes, if proved to be effective, it could be approved for routine use across the NHS.
The trial is the latest step on a long journey for RFH and UCL researchers and their partners, that began with the identification of ACLF in 2001 as a distinct clinical syndrome that occurs in patients with cirrhosis. The intellectual property for the technology was patented by UCL in 2009 and licensed to a spin-out company, Yaqrit. Pre-clinical testing was supported by grants from the Medical Research Council and Department of Health and Social Care. The previous human safety trial was made possible by an EU Horizon 2020 grant.
Additional co-principal investigators include Prof Jalan at University College London (UCL), Dr Sameer Patel at Kings College Hospital, London, and Dr Mansoor Bangash at the Queen Elizabeth Hospital, Birmingham.
Image: L- R Prof Rajiv Jalan and Prof Banwari Agarwal
