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US surgeons successfully test pig kidney transplant in human patient

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NEW YORK, Oct. 19 (Reuters) – For the first time, a pig kidney has been transplanted into a human without triggering immediate rejection by the recipient’s immune system, a potentially major breakthrough that could potentially help alleviate a severe shortage of human organs to be transplanted. .

The procedure performed at NYU Langone Health in New York City involved using a pig whose genes had been altered so that its tissues no longer contained a molecule known to trigger almost immediate rejection.

The recipient was a brain-dead patient with signs of kidney dysfunction whose family consented to the experience before she was taken off life support, researchers told Reuters.

For three days, the new kidney was attached to her blood vessels and kept outside her body, allowing researchers to access it.

The results of the transplanted kidney function tests “looked pretty normal,” said transplant surgeon Dr. Robert Montgomery, who led the study.

The kidney was producing “the amount of urine you would expect” from a transplanted human kidney, he said, and there was no evidence for the early and vigorous rejection seen when unmodified pig kidneys are transplanted. in non-human primates.

The recipient’s abnormal creatinine level – an indicator of poor kidney function – returned to normal after the transplant, Montgomery said.

In the United States, nearly 107,000 people are currently waiting for an organ transplant, of which more than 90,000 are waiting for a kidney, according to the United Network for Organ Sharing. Wait times for a kidney are on average three to five years.

Researchers have been working for decades on the possibility of using animal organs for transplants, but have been stuck on how to avoid immediate rejection by the human body.

Montgomery’s team hypothesized that removing the pig’s gene for a carbohydrate that triggers rejection – a sugar molecule, or glycan, called alpha-gal – would prevent the problem.

The genetically modified pig, nicknamed GalSafe, was developed by the Revivicor unit of United Therapeutics Corp (UTHR.O). It was approved by the United States Food and Drug Administration in December 2020, for use as a food for people with allergies to meat and as a potential source of human therapeutics.

Medical products developed from pigs would still require specific FDA approval before being used in humans, the agency said.

Other researchers wonder if GalSafe pigs can be sources of everything from heart valves to skin grafts for human patients.

NYU’s kidney transplant experiment should pave the way for trials in patients with end-stage kidney disease, possibly within the next two years, said Montgomery, himself a heart transplant recipient. These trials could test the approach as a short-term solution for critically ill patients until a human kidney is available, or as a permanent transplant.

The current experiment involved a single transplant and the kidney was only left in place for three days, so any future trials are likely to uncover new hurdles that will need to be overcome, Montgomery said. The participants would likely be patients with a low chance of receiving a human kidney and a poor prognosis on dialysis.

“For many of these people, the death rate is as high as for some cancers, and we are not shy about using new drugs and doing new trials (in cancer patients) when it could give them a few months. . more life, ”said Montgomery.

Researchers worked with medical ethicists, legal and religious experts to examine the concept before asking a family for temporary access to a brain-dead patient, Montgomery said.

Reporting by Nancy Lapid; Editing by Michele Gershberg and Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

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2/ https://www.reuters.com/business/healthcare-pharmaceuticals/us-surgeons-successfully-test-pig-kidney-transplant-human-patient-2021-10-19/

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