The surgery performed on January 7, 2022 marked the first time in history that a pig organ was transplanted into a human.
The patient, who received a gene-edited pig heart, survived the operation and initially showed signs of recovery.
Prior to this live human surgery, in 2021, surgeons at NYU Langone Health in New York tested gene-edited pig kidney transplants on two brain-dead individuals. The transplanted kidneys were not rejected and functioned normally while the bodies were maintained on ventilators.
Most research in xenotransplantation had previously been conducted on primates. However, scientists hope that this successful gene-edited pig heart transplant will serve as an important step toward clinical trials of animal-to-human organ transplantation, helping to overcome longstanding scientific and ethical barriers.
Researchers had 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, lead surgeon of the xenotransplantation program at the University of Maryland, the FDA was initially concerned about ensuring that donor pigs were sourced from certified medical-grade facilities and recommended that the team perform 10 pig-to-baboon heart transplants before moving to human subjects.
However, 57-year-old David Bennett gave Mohiuddin’s team an exceptional opportunity. Bennett had depended on a heart-lung bypass machine for nearly two months and could no longer sustain circulation due to severe arrhythmias. He was also not eligible for a human donor heart because of past noncompliance with medical treatment.
Given the life-threatening condition of the patient, the FDA granted emergency authorization for the team to transplant the gene-edited pig heart into Bennett.
The surgery proceeded smoothly, and the transplanted heart functioned well afterward, Dr. Mohiuddin reported.
The surgical team monitored Bennett’s immune response and heart function closely.
Dr. Mohiuddin stated that the research team would continue controlled clinical trials and may seek approval for additional xenotransplant procedures for patients in urgent need of organ replacement.