won Food and Drug Administration approval in 2020 to be used as a source of food, and a potential source for human therapeutics. The FDA determined there was no detectable level of alpha-gal across multiple generations of the pigs.
David Ayares, president and chief scientific officer of Revivicor, holds a package of frozen meat during an interview at the company’s offices in Blacksburg, Va., on May 30, 2024. (AP Photo/Shelby Lum)David Ayares, president and chief scientific officer of Revivicor, holds a package of frozen meat during an interview at the company’s offices in Blacksburg, Va., on May 30, 2024. (AP Photo/Shelby Lum)
But where does organ transplantation come in? There aren’t enough donated human organs to go around so researchers are— and that same alpha-gal sugar is a big barrier. It causes the human immune system to immediately destroy a transplanted organ from an ordinary pig. So the first gene that Revivicor inactivated as it began genetically modifying pigs for animal-to-human transplants was the one that produces alpha-gal.While xenotransplants still are experimental, Revivicor’s
won Food and Drug Administration approval in 2020 to be used as a source of food, and a potential source for human therapeutics. The FDA determined there was no detectable level of alpha-gal across multiple generations of the pigs.Revivicor, a subsidiary of United Therapeutics, isn’t a food company — it researches xenotransplantation. Nor has it yet found anyone in the agriculture business interested in selling GalSafe pork.
Still, “this is a research pig that FDA approved so let’s get it to the patients,” is how Ayares describes beginning the shipments a few years ago.
Revivicor’s GalSafe herd is housed in Iowa and to keep its numbers in check, some meat is periodically processed in a slaughterhouse certified by the U.S. Agriculture Department. Revivicor then mails frozen shipments to alpha-gal syndrome patients who’ve filled out applications for the pork.“Lisa helped bring us closer to realizing a future where someone does not have to die for another person to live,” Montgomery said. “She will forever be remembered for her courage and good nature.”
Back in April, the 54-year-old Pisano told The Associated Press that she knew the pig kidney might not work but “I just took a chance. And you know, worst case scenario, if it didn’t work for me, it might have worked for someone else.”Pisano was the second patient ever to receive a kidney from a gene-edited pig. The first,
received his transplant at Massachusetts General Hospital and died in early May, nearly two months later. His doctor has said he died of preexisting heart disease, not as a result of the transplant.More than 100,000 people are on the U.S. transplant waiting list, most who need a kidney, and thousands die waiting. Several biotech companies are genetically modifying pigs so their organs are more humanlike, less likely to be destroyed by people’s immune systems.