Next Step Planned in Pig-Organ Transplants

"As part of long-term efforts to address the shortage of lifesaving organs, scientists plan to extend the duration of studies in which genetically modified pig organs are transplanted into brain-dead individuals.

The move could provide crucial data to help launch clinical trials of animal-to-human transplants in living patients -- but it also raises ethical and scientific challenges for the doctors and families involved.

Scientists at NYU Langone Health in New York City plan to study how pig kidneys function in brain-dead individuals for a period of two-to-four weeks, according to Robert Montgomery, director of the NYU Langone Transplant Institute.

In the U.S., brain death is defined as the irreversible cessation of all brain function, even if heart and lung activity can be maintained with machines. The planned NYU research would keep brain-dead individuals on mechanical ventilation for significantly longer than previous research.

In four earlier studies at NYU, families and a university research oversight committee agreed to let scientists study pig hearts and pig kidneys in their loved ones' bodies for up to 72 hours.

The organs came from pigs that had undergone gene edits designed to make them more suitable for transplantation in people.

That research team had chosen the shorter time period to gather information about whether the human immune system would immediately reject the pig organs, and to avoid delaying the families' mourning process, Dr. Montgomery said.

Previous research involving transplanting pig organs into baboons showed that the pig organs can fail in the first few days after transplantation.

Pig-to-baboon organ transplants also have indicated another risky period, at 14 to 30 days after transplant, Dr. Montgomery said.

Studying pig-organ transplants in brain-dead humans during the 14-to-30 day window could provide crucial information about the human immune system and offer a better model than baboons, Dr. Montgomery said.

A spokeswoman for the Food and Drug Administration said data from studies involving the brain-dead could be useful in helping advance the goal of starting clinical trials testing pig organs in people.

Family members say they are certain that Alva Capuano, one of two brain-dead individuals at NYU who received a pig heart over the summer, would have wanted to participate in the study and help advance organ donation. Ms. Capuano herself was the recipient of a kidney donated by her son. "I think it would be important to her to be helpful in any way to save another life," said Tim Capuano, her son.

More than 100,000 people in the U.S. are on the national waiting list for organs, according to the United Network for Organ Sharing, a nonprofit that, under contract with the federal government, helps allocate organs. More than 6,000 people die every year while waiting.

Even so, making the decision to donate Ms. Capuano's body for the pig-heart study "was monumentally hard on the entire family," said Richard Capuano, her husband of over 40 years. "Even though we realized she had already died and wasn't coming back, there is still a respirator on and there is still a heartbeat. Psychologically it plays a game with you."

Research with brain-dead individuals can be controversial in part because of deeply rooted social, cultural and religious traditions about respect for the dignity of the dead and handling of their bodies, said Rebecca Pentz, a professor and bioethicist at Winship Cancer Institute and Emory University School of Medicine. She was a co-author of ethics guidelines for research on the brain-dead, published in 2005, that recommended studies be limited to one day, unless there were valid scientific reasons for going longer. "I can't imagine we can ask a family to do this for four weeks," Dr. Pentz said.

Jayme Locke, director of the Heersink School of Medicine Comprehensive Transplant Institute at the University of Alabama at Birmingham and lead surgeon on three pig-kidney studies in brain-dead individuals, said she thinks longer studies can yield important science.

James Parsons, a 57-year-old carpenter from Huntsville, Ala., who was found to be brain-dead after a motorcycle accident, participated in a pig-kidney transplant study at UAB. Julie O'Hara, Mr. Parsons's former wife, said the family conducted a celebration of his life while the study was still under way, so family and friends could begin mourning. Ms. O'Hara said the family would have allowed the study to continue longer if the scientists requested it. "Jim's soul was gone. He was no longer present in his body," Ms. O'Hara said." [1]

1. U.S. News: Next Step Planned in Pig-Organ Transplants
Marcus, Amy Dockser. 
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 29 Aug 2022: A.3.