US regulatory agency signals willingness to allow first xenotransplant trials.
The heart recipient recovered from the surgery, and his body did not reject the genetically modified organ, but he died two months later. Physicians later found traces of porcine cytomegalovirus in the pig heart and now think that the pathogen might have contributed to the man’s death. An investigation is under way.
Fishman says it’s thought that the virus doesn’t infect human cells, but it has been linked with reduced survival times for non-human primates that received pig organsEven though the heart-transplant recipient died, the surgery represents an enormous accomplishment, Kirk says. The science of xenotransplantation, he says, has advanced to the point that there is an answer to the biggest question — can a pig organ support life in a human who would otherwise die? And the answer is yes.
The high-profile transplants have “increased public awareness of the field” and have “made this an optimal time for public conversation” and clinical trials, said Wilson Bryan, director of the FDA’s Office of Tissues and Advanced Therapies in Silver Spring, Maryland, at the meeting.But there are still many questions that must be answered before xenotransplantation can become standard clinical practice.
Other panellists discussed whether it would be possible to develop a standard ‘package’ of immunosuppressive drugs for humans, and genetic modifications for pigs, to ensure success. Fishman said that there probably won’t be one package that works for everyone. Instead, it will need to be tailored on the basis of the organ being transplanted and the recipient’s condition, as is done in human-to-human organ transplants.
Researchers at the University of Alabama at Birmingham and the University of Maryland Medical Center in Baltimore have signalled their desire to begin xenotransplant clinical trials soon. The FDA hasn’t publicly indicated what it will do with the advice collected during the meeting, but
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