Liver dialysis device is ‘safe and effective’ in trial

A ‘potentially transformative’ clinical trial of liver dialysis has been completed successfully in the UK, it was announced today.

Researchers from UCL, the Royal Free Hospital, UCL spin-out Yaqrit and their collaborators say if a larger clinical trial proves successful, the DIALIVE device, invented by researchers at UCL’s Institute for Liver and Digestive Health, could be approved for clinical use within the next three years.

The trial – the first-in-human randomised, controlled clinical trial of a liver dialysis device – was found to be safe and it was associated with a substantial improvement in the severity of symptoms and organ function in more patients with acute-on-chronic liver failure (ACLF) compared with patients receiving standard of care.

A total of 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.

The results, published in the latest edition of The Journal of Hepatology, showed DIALIVE treatment was associated with quicker reversal of ACLF compared with standard of care, with ACLF resolving in about twice the number of patients. This was also associated with significant impact on the mechanisms underlying the development of ACLF.

DIALIVE treatment led to a significant reduction in endotoxins and improved albumin function, while there were improvements in the biomarkers of systemic inflammation, such as cytokines, endothelial function and markers of cell death.

With as little as three days’ treatment, patients whose ACLF resolved remained in remission for 28 days afterwards.

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 next step will be to conduct a larger trial with more patients.

Professor Rajiv Jalan, of UCL Institute for Liver and Digestive Health and inventor of DIALIVE, 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.”

Agarwal B, Bañares Cañizares R, Saliba F et al. Randomized, Controlled Clinical Trial of the DIALIVE Liver Dialysis Device versus Standard of Care in patients with Acute on Chronic Liver Failure. The Journal of Hepatology 1 June 2023.



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