The Food and Drug Administration is devising plans to allow clinical trials testing the transplantation of pig organs into humans, a person familiar with the matter said.
If the agency follows through, the trials could be a key step in an effort to ease the deadly shortage of human donor organs. The planning comes in the wake of a handful of experimental surgeries involving the transplantation of pig organs into a critically ill man and in brain-dead patients.
Transplant doctors and FDA officials discussed possible regulatory requirements for interspecies transplantation, or xenotransplantation, at a two-day public advisory committee meeting convened by the agency [June 29]. The officials raised concerns that pig viruses might be transmitted not only to pig organ recipients but also to their friends and family members as well as the transplant teams.
Allan Kirk, a Duke University School of Medicine transplant surgeon who spoke at the meeting, said existing screening technology could help ensure that donor pigs are free of viruses. As is the case with transplants of human organs, there is no guarantee that pig organs would be pathogen-free, Dr. Kirk said, adding that clinical trials would allow for better oversight and data collection.
