In a world first, surgeons have transplanted two kidneys from a genetically modified pig into a human, with hopes that the ‘game-changing’ approach could help solve the organ shortage crisis.
The kidneys worked for more than three days during the experiment on a brain-dead patient, Jim Parsons, who was already on artificial life support with acute kidney injury and no prospect of recovery.
Senior author Dr Jayme Locke, of the University of Alabama at Birmingham (UAB), said: "This game-changing moment in the history of medicine represents a paradigm shift and a major milestone in the field of xenotransplantation, which is arguably the best solution.
"We have bridged critical knowledge gaps and obtained the safety and feasibility data necessary to begin a clinical trial in living humans with end-stage kidney failure disease."
Pig heart valves are already used widely in humans, and earlier this month, 57-year-old David Bennett became the first person in the world to get a pig heart.
Xenotransplantation – in which organs from animals are put into humans – has been a huge goal for scientists over the years, and now Locke and her colleagues have used a novel pre-clinical model to answer critical safety questions.
Locke said: "This human preclinical model is a way to evaluate the safety and feasibility of the pig-to-non-human primate model, without risk to a living human.
"Our study demonstrates major barriers to human xenotransplantation have been surmounted, identifies where new knowledge is needed to optimise xenotransplantation outcomes in humans, and lays the foundation for the establishment of a novel preclinical human model for further study."
The family of 57-year-old Parsons – who was a registered organ donor – gave permission for the four-hour procedure to go ahead at the Legacy of Hope Donor Recovery Centre.
The kidneys filtered blood and urine, and were not immediately rejected – remaining viable until the study was ended 77 hours after transplant.
Parsons had wanted to allow his organs to help others upon his death, but they were not suitable. Instead, he was maintained on a ventilator to keep his body functioning, before his kidneys were removed and replaced with the pig’s.
Locke said: "Mr Parsons and his family allowed us to replicate precisely how we would perform this transplant in a living human.
"Their powerful contribution will save thousands of lives, and that could begin in the very near future.
"Mr Parsons' gift honours his legacy and firmly establishes the viability, safety and feasibility of this preclinical model. Because of his gift, we have proposed this to be known as 'The Parsons Model.'”
Parsons' ex-wife Julie O'Hara, and their children, Ally, David and Cole, made the decision, along with his sisters and mother.
O'Hara said: "Jim was a never-met-a-stranger kind of guy who would talk to anyone and had no enemies - none.
"Jim would have wanted to save as many people as he could with his death, and if he knew he could potentially save thousands and thousands of people by doing this, he would have had no hesitation.
"Our dream is that no other person dies waiting for a kidney, and we know that Jim is very proud that his death could potentially bring so much hope to others."
With kidney disease killing more people each year than breast or prostate cancer, Locke believes a ‘radical solution’ is needed for the organ supply crisis, saying the domestic pig is a ‘promising organ source’.
Locke described the initial results – which were reported in the American Journal of Transplantation – as ‘encouraging’, saying the kidneys ‘turned beautiful and pink’ and started making urine within 23 minutes.
The recipient's abnormal creatinine levels - a metabolic indicator of kidney function - returned to normal after the transplant.
The success of the experiment paves the way for a Phase 1 clinical trial at the university for patients with end-stage kidney failure.
In the US, nearly 107,000 people are waiting for organ transplants, most needing a kidney – with waiting times averaging three-to-five years.
There are about 7,000 on the list in the UK, over half of whom are in need of a kidney. Last year, more than 470 people died while waiting for an organ.
The Food and Drug Administration in the US has approved the use of genetically-modified pigs for this type of research, while the NHS Blood and Transplant says matching more human donors remains the priority for now.
A spokesperson said: "There is still some way to go before transplants of this kind become an everyday reality.
"While researchers and clinicians continue to do our best to improve the chances for transplant patients, we still need everyone to make their organ donation decision and let their family know what they want to happen if organ donation becomes a possibility."
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