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FDA Planning to Allow Clinical Trials of Pig Organ Transplants

Move could be an important step in effort to ease the shortage of human donor organs


While transplanting a genetically modified pig heart into a human without immediate rejection by the patient’s body brought doctors a step closer to solving the organ shortage, the procedure remains controversial for some.


By Amy Dockser Marcus and Liz Essley Whyte, WSJ

Updated June 30, 2022 5:31 pm ET



The Food and Drug Administration is devising plans to allow clinical trials testing the transplantation of pig organs into humans, a person familiar with the matter said.


If the agency follows through, the trials could be a key step in an effort to ease the deadly shortage of human donor organs. The planning comes in the wake of a handful of experimental surgeries involving the transplantation of pig organs into a critically ill man and in brain-dead patients.


It is unclear when the trials would begin, the person said, adding that proposals from researchers would be handled case by case.



Surgeons transplanting a genetically modified pig heart into a patient in Baltimore early this year.

PHOTO: UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE/EPA/SHUTTERSTOCK

Several research groups have recently sought guidance from the FDA on how to begin clinical trials or plan to seek the agency’s approval to launch trials, including those at the University of Alabama at Birmingham and the University of Maryland Medical Center in Baltimore.


Clinical trials allow for the study of larger numbers of patients, robust data collection and strict safety monitoring. In this case, they would likely involve a small number of hospitals with experience with pig-organ transplants, according to transplant doctors.


Doctors at the University of Maryland Medical Center in January transplanted a genetically modified pig heart into David Bennett, a critically ill, 57-year-old handyman from Hagerstown, Md., to extend his life. Mr. Bennett died two months later.


The Maryland researchers received a special FDA emergency authorization to perform the experimental surgery.


About 20 days after the surgery, the heart transplanted into Mr. Bennett was found to harbor a pig virus, researchers reported in June in the New England Journal of Medicine. Whether the virus caused or contributed to Mr. Bennett’s death remains under investigation, the researchers said, adding that they felt clinical trials of pig-to-human organ transplantation should begin despite the uncertainty.


The University of Maryland researchers said the agency had previously asked them to conduct additional studies involving baboons before attempting a clinical trial. The scientists are moving forward with those animal studies while seeking FDA guidance about what additional steps might be necessary to open human trials, said Dr. Muhammad M. Mohiuddin, professor of surgery at the University of Maryland School of Medicine and one of the doctors involved in Mr. Bennett’s surgery.


Researchers at the University of Alabama at Birmingham plan to seek FDA approval to launch a clinical trial, according to Dr. Jayme Locke, director of the university’s Heersink School of Medicine’s Comprehensive Transplant Institute.


The Alabama program reported earlier this year that it had transplanted pig kidneys into the body of a brain-dead person, with the organs producing urine before the experiment was stopped.


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Researchers at NYU Langone Transplant Institute are also interested in pursuing clinical trials, said Dr. Robert Montgomery, the director. “We are on the path to clinical trials,” he said.


Transplant doctors and FDA officials discussed possible regulatory requirements for interspecies transplantation, or xenotransplantation, at a two-day public advisory committee meeting convened by the agency Wednesday. The officials raised concerns that pig viruses might be transmitted not only to pig organ recipients but also to their friends and family members as well as the transplant teams.


Allan Kirk, a Duke University School of Medicine transplant surgeon who spoke at the meeting, said existing screening technology could help ensure that donor pigs are free of viruses. As is the case with transplants of human organs, there is no guarantee that pig organs would be pathogen-free, Dr. Kirk said, adding that clinical trials would allow for better oversight and data collection.


More than 100,000 people in the U.S. are on the national waiting list for kidneys, livers, hearts and other organs, according to the United Network for Organ Sharing, a nonprofit that under contract with the federal government helps allocate organs.


Despite efforts to increase the number of donor organs, more than 6,000 people die each year while waiting to get a new organ.


Write to Amy Dockser Marcus at amy.marcus@wsj.com and Liz Essley Whyte at liz.whyte@wsj.com


Appeared in the July 1, 2022, print edition as 'FDA Set To Allow Pig-Organ Testing in Humans'.



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