Researchers have completed the first successful in-patient trial of liver dialysis.
The DIALIVE device, invented by researchers at UCL’s Institute for Liver and Digestive Health, was found to be safe and effective, research suggests.
According to a new study, the device is associated with substantial improvement in the severity of symptoms and organ function in a greater proportion of patients with acute-on-chronic liver failure (ACLF), when compared with patients receiving standard of care.
The next step would be a larger clinical trial, which if successful could see DIALIVE approved for clinical use within the next three years.
Dialysis is a technique to clean the blood of harmful substances, more familiar in the treatment of those with reduced or no kidney function.
Patients on kidney dialysis must undergo treatment for several hours each day in order to live.
However, due to the liver’s regenerative qualities, researchers expect liver dialysis will be able to provide longer term benefits after a short stint of treatment lasting several days.
It is estimated that across the world there are around 100 million people living with cirrhosis of the liver and 10 million who have cirrhosis plus an additional complication.
Around three million of those individuals have ACLF, a condition that can cause liver function to suddenly decline, placing individuals at high risk of short-term death.
The UK sees around 15,000 ACLF patients each year whose treatment costs the NHS in the region of £100,000 per patient, without improving their risk of death, the experts suggest.
Dr Banwari Agarwal, chief investigator of the DIALIVE trial from the Royal Free Hospital and honorary associate professor at the UCL Division of Medicine, said: “It gives me enormous pleasure to see the promise of this novel liver dialysis device for the treatment of acute-on-chronic liver failure.
“The intervention has the potential to transform the care provided to the ever-increasing number of patients and their families suffering from the effects of living with what is essentially a terminal illness for many.
“It has the potential to transform the therapeutic options available to clinicians across the world for patients with ACLF.”
The liver is a complex organ that performs more than 500 functions, including removal of harmful substances from the blood and absorbing nutrients.
One of its roles is to produce large quantities of a protein called albumin, which travels around the body acting as a sort of ‘mobile liver’ that absorbs unwanted substances.
However, when its function is seriously reduced, such as through alcohol abuse, obesity or viral infection, less albumin is produced.
In ACLF, its function is also seriously impaired – liver cells die and the gut begins to leak bacteria into the bloodstream, which can cause an inappropriate immune response and multiorgan failure.
Researchers say the study is the first-in-human randomised, controlled clinical trial of a liver dialysis device.
In total, 32 patients were treated with DIALIVE or standard of care for up to five days and the outcomes were recorded at days 10 and 28.
According to the findings, DIALIVE treatment was associated with faster reversal of ACLF compared with standard of care, with ACLF resolving in about twice the number of patients.
The treatment also led to a significant reduction in endotoxins, which are released when bacteria die, and improved albumin function.
The study further found that despite receiving as little as three days’ treatment, patients whose ACLF resolved remained in remission for 28 days afterwards.
Professor Rajiv Jalan, UCL Institute for Liver and Digestive Health, part of the UCL Division of Medicine, inventor of DIALIVE and co-founder of Yaqrit, said: “As academics it can be difficult to define a disease then translate this knowledge into a clinical solution that makes a real difference to people’s lives.
“So the results of the DIALIVE trial are an emotional moment, which wouldn’t have been possible without scientific collaboration between the UK, European colleagues and funding from the European Commission.
“My hope is that within a few years we will start to fulfil the urgent unmet need for treating acute-on-chronic liver failure and improve outcomes for patients.”
The study, conducted by researchers from UCL, the Royal Free Hospital, UCL spin-out Yaqrit and collaborators, is published in The Journal of Hepatology.