National Health Service is to test a potentially life-saving new treatment for a fatal liver disease that causes the body's vital organs to fail.
Thirteen major hospitals will use the device, which purifies patients' blood contaminated with toxins resulting from acute-chronic liver failure (ACLF).
ACLF is a severe and difficult-to-treat form of liver disease associated with obesity, alcohol and hepatitis, in which patients suddenly deteriorate and must be admitted to the intensive care unit. Three out of four victims are diagnosed only when the disease has already become life-threatening.
Seven out of 10 people with the disease die within 28 days, and few of them are eligible for liver transplantation, which is the only existing way to reverse ACLF.
Seventy-two seriously ill patients will take part in a randomized controlled trial of the device, called Dialive, starting early next year. Doctors involved say it “brings new hope” and could reduce the disease's high death rate.
If successful, it could become the first form of liver dialysis in global medicine. Dialive aims to aid healing by removing dysfunctional albumin (a protein produced by the liver) and replacing it with clean, functional albumin.
The Liver Intensive Care System works in a similar way to what happens during hemodialysisa long-established treatment for people whose kidneys have stopped working properly.
Patients are hooked up to a Dialive device while it removes harmful substances from their blood, which helps their liver and other organs recover and increases their chances of survival.
Trial participants will already be suffering from failure of two or more organs. They will undergo treatment sessions on days one, two and three, and then up to four more during the first 10 days.
“Our goal is to demonstrate that we can address life-threatening ACLF more often and faster than standard care, and thereby impact both patients' hospital stays and chances of survival,” said Rajeev Jalan, a senior liver specialist and co-principal investigator of the study who founded Yakritmedical innovation company that developed this device.
“These are seriously ill patients with multiple organ failure and a high risk of death, so there is an urgent need for effective treatment not only here but throughout the world.
“Dialive clears the blood of toxins that accumulate in the body due to the liver not working, and therefore prevents further damage and allows the liver to regenerate,” added Jalan, professor of hepatology at University College London (UCL).
Yaqrit is a UCL spin-out company that specializes in developing new medicines and devices to treat severe liver diseases, which are on the rise globally as a result of soaring obesity, alcohol abuse and hepatitis infections.
An estimated 2 million people in the UK suffer from some form of liver disease, and the incidence rate has quadrupled in the last 50 years. About 60,000 of them suffer from cirrhosis of the liver, severe inflammation and scarring that puts them at risk of death. Liver disease kills more than 12,000 people a year.
The government-funded National Institute for Health and Care Research (NIHR) is funding the £2.2 million study after previous smaller scale study In 2023, a safety and efficacy study found that Dialive showed promise for the treatment of ACLF.
Ten of the 15 patients treated experienced a change in ACLF compared with five of the 15 who received standard treatment alone. Dialive patients also recovered faster than others.
Dr Rohit Saha, a consultant at the Royal Free Hospital in London and another co-principal investigator of the study, said: “Many [patients with ACLF] dying because their bodies become trapped in a destructive cycle of inflammation that current treatments cannot reverse.
“Dialive…offers new hope that could put this disease into remission and give us a new path forward for our sickest liver patients for the first time in decades.”
King's and University College London hospitals in the capital and Queen Elizabeth Hospital in Birmingham will be the first three of 13 teaching hospitals to enroll patients.
“Every year thousands of people are admitted to NHS hospitals with ACLF and there are three possible outcomes: transplant, death or recovery.
Dr Mansour Bangash, Queen Elizabeth's consultant and principal investigator, said: “If we can help more patients recover with new devices such as Dialive, while fighting major infections, then we can improve survival rates, stabilize their health and ensure they are in the best possible condition for a transplant-free future.”
The NIHR said it was covering the cost of the trial because, if it works, the device could mean patients with severe liver disease will no longer need a liver transplant.
Professor Mike Lewis, Scientific Director for Innovation, said: “Acute chronic liver failure is a dangerous and often fatal condition. The only available treatment for it is transplantation, which is not always possible or the organ available.
“If the NIHR-funded Dialive trial is successful, it will bring huge benefits to patients by providing treatments for ACLF that will save lives and shorten hospital stays. This research, funded at its best by taxpayers, makes treatment available on the NHS when it is needed.”
