The surgery performed on January 7, 2022 marked the first time in history that a pig organ was transplanted into a living human being.
The patient, who received a gene-edited pig heart, survived the operation and initially showed signs of recovery.
Before this live human surgery, in 2021, surgeons at NYU Langone Health in New York had transplanted gene-edited pig kidneys into two brain-dead individuals. The kidneys were not rejected and functioned normally while the bodies were maintained on ventilators.
Most xenotransplantation research to date had been conducted on primates. However, researchers hoped that this successful gene-edited pig heart transplant would pave the way for clinical animal-to-human organ transplantation and help overcome current barriers.
Researchers had previously submitted an application to the U.S. Food and Drug Administration (FDA) to begin clinical trials of pig-to-human heart transplantation, but the request was denied.
According to Dr. Muhammad Mohiuddin, the lead surgeon of the xenotransplantation program at the University of Maryland, the FDA was initially concerned about ensuring that donor pigs were sourced from approved medical-grade facilities and requested that the team first perform 10 pig-to-baboon heart transplants before moving to humans.
However, 57-year-old David Bennett gave Mohiuddin’s team an exceptional opportunity.
Bennett had relied on a heart-lung bypass machine for nearly two months and could no longer maintain circulation due to severe arrhythmias. He was also ineligible for a human donor heart because of a history of non-compliance with medical treatment.
Facing imminent death, the FDA granted emergency authorization for the team to transplant the gene-edited pig heart into Bennett.
The surgery was smooth, and the transplanted heart functioned well afterward, Dr. Mohiuddin reported.
The surgical team monitored Bennett’s immune response and heart performance closely.
Dr. Mohiuddin stated that the research team will continue controlled clinical trials and may seek approval to perform additional xenotransplant procedures for patients in critical need of organ transplantation.