The agency plans to handle proposals from researchers involving pig organ transplants on a case by case basis. Research groups at the University of Alabama at Birmingham and Baltimore-based University of Maryland Medical Center have recently sought FDA guidance on how to launch such trials, the Journal reported.
The plans come amid a series of recent experimental surgeries involving the transplant of pig organs into humans. In January, a surgical team at Baltimore-based University of Maryland performed the first transplant of a genetically modified pig heart in a 57-year-old patient with end-stage heart disease after receiving special “compassionate use” authorization from the FDA. The patient died March 8. Several factors may have contributed to the patient’s death, including a common pig virus called cytomegalovirus.
During a June 29 meeting, FDA officials and transplant physicians gathered to discuss potential regulatory requirements for xenotransplantation. Officials have raised concerns about pig viruses being transmitted to organ recipients, as well as to their close contacts.
Transplant surgeons said existing screening technology can help determine whether donor pigs harbor viruses, and that as with human organs, there is no way to guarantee pig organs would be pathogen-free.
