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By LAURAN NEERGAARD, AP Medical Writer
WASHINGTON (AP) â The first clinical trial is getting underway to see if transplanting pig kidneys into people might really save lives.
United Therapeutics, a producer of gene-edited pig kidneys, announced Monday that the studyâs initial transplant was performed successfully at NYU Langone Health.
Itâs the latest step in the quest for animal-to-human transplants. A second U.S. company, eGenesis, is preparing to begin its own pig kidney clinical trial in the coming months. These are the first known clinical trials of what is called xenotransplantation in the world.
To protect the study participantâs identity, researchers arenât releasing information about when the NYU surgery was performed or further patient information.
NYUâs Dr. Robert Montgomery, who led the transplant team, told The Associated Press his hospital has a list of other patients interested in joining the small trial, which will initially include six people. If all goes well, it could be expanded to up to 50 as additional transplant centers join.
The Food and Drug Administration is allowing the rigorous studies after a series of so-called âcompassionate useâ experiments, with mixed results. The first two gene-edited pig kidney transplants were short-lived.
Then doctors began working with patients who badly needed a kidney but werenât as sick as prior recipients. At NYU, an Alabama womanâs pig kidney lasted 130 days before she had to return to dialysis. The latest record, 271 days, was set by a New Hampshire man transplanted at Massachusetts General Hospital; he also is back on dialysis after the pig organ began declining and was removed last month. Others known to be living with a pig kidney are another Mass General patient and a woman in China.
âThis thing is moving in the right directionâ as doctors learn from each patientâs experience, NYUâs Montgomery said. He noted the ability to resume dialysis also gives a safety net.
More than 100,000 people, most needing kidneys, are on the U.S. transplant list, and thousands die waiting. As a potential alternative, scientists are genetically altering pigs so their organs are more humanlike, less likely to be immediately attacked and destroyed by peopleâs immune system.
United Therapeuticsâ trial is testing pig kidneys with 10 gene edits, âknocking outâ pig genes that trigger early rejection and excessive organ grown and adding some human genes to improve compatibility.
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