The surgery performed on January 7, 2022, marked the first time a pig organ had been transplanted into a living human. The patient received a genetically modified pig heart, survived the operation, and was on the path to recovery.
Before the surgery on a living patient, in 2021, surgeons at NYU Langone Health in New York had experimentally transplanted genetically modified pig kidneys into two brain-dead individuals. The transplanted kidneys were not rejected after transplantation and functioned normally while the brain-dead bodies were maintained on ventilators.
Most research up to that point had been conducted on primates. However, researchers hoped that this genetically modified pig heart transplant would become a starting point for clinical xenotransplantation—transplanting animal organs into humans—and help overcome existing barriers.
The researchers had submitted an application to the U.S. Food and Drug Administration (FDA) to conduct clinical trials of pig heart transplantation in humans, but it was rejected. According to Dr. Muhammad Mohiuddin, the surgeon leading the research team at the University of Maryland, the FDA was initially concerned about ensuring that the pigs came from a medical-grade facility and wanted the team to transplant pig hearts into 10 baboons before moving on to human trials.
However, 57-year-old patient David Bennett gave Mohiuddin’s team the opportunity to perform the transplant under special authorization. Bennett had been dependent on a heart-lung machine for nearly two months and could no longer have his blood pumped effectively because of an irregular heartbeat. He was also ineligible to receive a human heart transplant due to a history of not following medical treatment instructions.
Given the patient’s life-threatening condition, the FDA authorized the research team to transplant a genetically modified pig heart into Bennett. The surgery went smoothly, and the transplanted heart functioned very well, Dr. Mohiuddin said.
The surgical team would continue to monitor Bennett’s immune responses and heart function. Dr. Mohiuddin also stated that the research team would continue working toward controlled clinical trials and might apply for permission to perform similar surgeries if other patients urgently needed organ transplantation.