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FDA approved pig to human transplant experiment fails

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Details have been released of the death of a 57-year-old man at Maryland Hospital, just two months after undergoing a highly experimental transplant procedure.

David Bennett Sr. who died last March required a heart transplant due to what his doctors confirmed as heart failure and irregular heartbeat.

Bennet Sr. was deemed ineligible for a human heart by his doctors, citing his history of not complying with medical instructions requiring the strict use of immune-suppressing medicines, or the alternative of an implanted heart pump.

Doctor Bartley Griffith, of the University of Maryland School of Medicine, performed the 7-hour long experimental surgery on 7 January 2022. Dr. Griffith told Associated Press that the Food and Drug Administration (FDA) had authorized the surgery under compassionate use rules for emergency situations.

Bennet Sr. underwent the procedure to have his heart replaced with one of a genetically edited pig. The animal heart had been modified to remove the pig genes that trigger the hyper-fast rejection with the addition of human genes to help the patient’s body accept the organ.

Dr. Griffith said despite being terribly ill, his patient (Mr Bennet) had been recovering following surgery but woke one-morning showing symptoms similar to infection.

Doctors at the University attempted to pinpoint the cause of Bennet’s deteriorating condition by conducting a series of tests. He was given a course of antibiotics, antiviral medications, and immune-boosting treatments. But despite efforts, Griffith said the transplanted pig heart became swollen, filling with fluid and blood, and ceased to function.

While doctors reported the transplanted pig heart had passed testing by the FDA, the team located viral DNA inside the pig heart (porcine cytomegalovirus). Dr. Griffith said “What was the virus doing, if anything, that might have caused the swelling in his heart? Honestly, we don’t know.”

The scientific director of the University’s xenotransplant program told Associated Press more sophisticated testing is under development to “make sure we don’t miss these kinds of viruses.

CBS News reported last March that the gene-edited pigs used in the experiments were provided by Revivicor, a subsidiary of United Teraputics, one of several biotech companies in the running to develop suitable pig organs for potential human transplant.

While all other previous pig-to-human transplants have failed; largely due to patient’s accelerated bodily rejection of animal organs; Maryland doctors remain hopeful that valuable insights they have gained might help to persuade the FDA to allow clinical trials for other gene-edited organs.

In a statement by David Bennet Jr. released by the University of Maryland School of Medicine, he said, “We are grateful for every innovative moment, every crazy dream, every sleepless night that went into this historic effort,” adding “We hope this story can be the beginning of hope and not the end.”

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