Scientists will soon test whether livers from a gene-edited pig could treat people with sudden liver failure – by temporarily filtering their blood so their own organ can rest and maybe heal.
The first-of-its-kind clinical trial has been cleared by the US Food and Drug Administration (FDA), according to pig producer eGenesis, which announced the step Tuesday with its partner OrganOx.
It’s the latest step in attempts to use gene-edited pig organs to save human lives.
Liver disease accounts for about one in every 25 deaths worldwide. In the US, the death toll is more than 66,000 per year, while across the European Union nearly 86,000 people died from cirrhosis and other chronic liver diseases in 2021.
There are few treatment options for people with sudden liver failure – which is less common and typically emerges in people with no pre-existing disease – and death rates are as high as 50 per cent.
Many patients don't qualify for a liver transplant or can't get a match in time.
The new study, which is expected to get underway later this spring, is a twist on the quest for animal-to-human organ transplants. Researchers won't transplant the pig liver but instead will attach it externally to study participants.
The liver is the only organ that can regenerate, but the question is whether having the pig's liver filter the patient's blood for several days could give it that chance.
In experiments with four deceased bodies, that “bridge” attempt showed the pig liver could support some functions of a human liver for two or three days, said Mike Curtis, CEO of eGenesis, which genetically modifies pigs so their organs are more human-like.
The trial will enroll up to 20 patients in intensive-care units who don't qualify for a liver transplant, he said.
A device made by Britain’s OrganOx, currently used to preserve donated human livers, will pump participants' blood through the pig liver.
