London: A novel dialysis device developed for treating severe liver failure has shown to be safe and effective, according to results of the first in-patient trial, led by researchers including those of Indian-origin.
Acute-on-chronic liver failure (ACLF) occurs in 30 per cent of hospitalised cirrhosis patients, leading to over one million deaths worldwide each year. Currently the only potential treatment for this condition is liver transplantat, which is available to very few patients
The new DIALIVE device was found to be safe and was associated with substantial improvement in the severity of symptoms and organ function in a greater proportion of patients with ACLF, when compared with patients receiving standard of care.
In the trial, 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 showed that DIALIVE treatment was associated with significantly faster reversal of ACLF compared with standard of care, with ACLF resolving in about twice the number of patients.
DIALIVE treatment also led to a significant reduction in endotoxins, which are released when bacteria die, and improved albumin function.
"It gives me enormous pleasure to see the promise of this novel liver dialysis device for the treatment of acute-on-chronic liver failure," said Dr Banwari Agarwal, Chief Investigator of the DIALIVE trial from the Royal Free Hospital, UK.
"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," said Agarwal, also the Associate Professor at the University College London.
Further, the trial results also showed improvements in biomarkers of systemic inflammation, such as cytokines, endothelial function and markers of cell death. Despite receiving as little as three days' treatment, patients whose ACLF resolved remained in remission for 28 days afterwards.
The next step will be a larger clinical trial, which if successful could see DIALIVE approved for clinical use within the next three years, said researchers at UCL's Institute for Liver and Digestive Health, who invented the device.
Worldwide, it is estimated that 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.