Pig livers to be used for treatment? FDA approves clinical trial for treatment of patients with chronic liver failure

eGenesis, a biotechnology company developing human-compatible organs for patients with organ failure, along with its partner OrganOx, a medical technology company, announced the clearance received by the U.S Food and Drug Administration (FDA) for the treatment of patients with acute-on-chronic liver failure.

FDA has given clearance for the investigational new drug (IND) application for EGEN-5784, a human-compatible, genetically engineered porcine liver, used in combination with the OrganOx extracorporeal liver cross-circulation (ELC) system.

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Who is eligible?

This procedure is done for patients with acute-on-chronic liver failure (ACLF) suffering from decompensated liver function in the intensive care setting, as per eGenesis. 

What is extracorporeal liver cross-circulation (ELC)?

With the aim of supporting the functionalities of a liver, a liver graft, either from a donor or a genetically modified pig, is circulated outside the human body. 

According to NBC News, an estimated 35,000 people in the U.S. are hospitalised each year due to liver issues and the death rates are as high as 50 per cent as many are not eligible for a liver transplant or can't get a match in time.

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Through the procedure, experts hope to support the function of a patient’s decompensated liver, in a way that may allow for the potential recovery of the patient’s native liver, or provide sufficient time to receive a liver transplant.

According to eGenesis, as a part of the Phase 1 trial, up to twenty (20) patients with ACLF (Grade 2 to Grade 3) and hepatic encephalopathy (≤ Grade 3) and ineligible for transplant will be enrolled across multiple U.S. centers. The trial will study the safety, performance, and clinical activity of the EGEN-5784 liver in combination with the OrganOx ELC system in these patients.

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