The surgery performed on January 7, 2022 marked the first time a pig internal organ was transplanted into a human. The patient who received a gene-edited pig heart survived the operation and was initially on the path to recovery.
Before this operation in a living patient, surgeons at NYU Langone Health in New York had already experimented in 2021 by transplanting gene-edited pig kidneys into two brain-dead individuals. The transplanted kidneys were not rejected and functioned normally while the brain-dead bodies were maintained on ventilatory support.
Most previous research had been conducted in non-human primates. However, researchers hoped that this gene-edited pig heart transplant would serve as a starting point for clinical animal-to-human organ transplantation, helping overcome current barriers in the field.
The researchers had submitted an application to the U.S. Food and Drug Administration (FDA) to begin a clinical trial of pig-to-human heart transplantation, but the request was rejected. According to Dr. Muhammad Mohiuddin, the lead surgeon of the research team at the University of Maryland, the FDA was initially concerned about ensuring that the pigs came from a proper medical-grade facility and wanted the team to perform pig heart transplants on 10 baboons before moving on to human transplantation.
However, David Bennett, a 57-year-old patient, gave Mohiuddin’s team a special opportunity to proceed directly with a human transplant. Bennett had been dependent on a heart-assist machine for nearly two months and could no longer receive adequate circulatory support because of severe abnormal arrhythmias. He was also not eligible for a human donor heart, due to a history of not complying with medical treatment instructions. Given that he was facing possible death, the FDA granted the research team emergency authorization to transplant a gene-edited pig heart into Bennett.
The surgery was successful, and the transplanted heart functioned very well, according to Dr. Mohiuddin. The surgical team planned to continue closely monitoring Bennett’s immune response as well as the function of the transplanted heart. Dr. Mohiuddin also said that the team would continue controlled clinical research and might apply to perform additional similar procedures if other patients in urgent need of transplantation became available.