Pressure mounts on FDA to expand pig-to-human organ transplant research

In January, doctors at the University of Maryland School of Medicine made history by successfully transplanting a pig heart into a human. The 57-year-old patient may have died two months later from complications of the experimental procedure, but the case has inspired scientists from across the medical field to urge the FDA to expand the scope and scope of human-to-pig transplant research. During a two-day conference in late June, FDA policy advisors and medical professionals discussed the future of xenotransplantation, and “most participants agreed that human trials are needed to answer the most pressing research questions,” it said Nature.

We’ve been stuffing pig organs into sick people since the early 1800s, but technology has made rapid advances over the past few decades, thanks in part to the advent of CRISPR technology and more potent immunosuppressive drugs. In 2017, researchers created the first human-pig hybrid embryo and developed a solution to potential interspecies viral infections. As of January 2022, genetically engineered pig kidneys have been implanted into brain-dead donor recipients with great success.

“Our goal is not to do a one-time thing, but to advance the field to help our patients,” said Dr. Jayme Locke, Chief Surgeon of the Kidney Study and Director of the UAB Incompatible Kidney Transplant Program the NYT. “What a wonderful day it will be when I can go to the clinic knowing I have a kidney for everyone waiting to see me.”

Humans have also performed numerous experimental pig organ transplants in primates such as baboons. But to do this safely and consistently with humans, researchers need to test the techniques on humans, said Caroline Zeiss, a veterinarian at the Yale School of Medicine Nature. For example, doctors found traces of porcine cytomegalovirus (PCMV) in the heart transplant patient who died earlier this year and believe it may have played a role in his death, but will not know for sure without further testing that it is a primate model – those that cannot be replicated in primates.

Researchers are only looking at “small, focused” clinical trials with “appropriately selected patients,” said Allan Kirk, a transplant surgeon at Duke University School of Medicine Nature. Researchers must answer a number of fundamental questions before the technology can be widely deployed, as well as determine the right mix of breeding and genetic manipulation needed to ensure the recipient’s body doesn’t reject them.

And while the decisions made during last week’s meeting may not have an immediate impact on the agency’s current stance on xenotransplantation, changes are reportedly afoot. That WSJ spoke to a “person familiar with the matter” in late June who claims the FDA is planning organ transplant trials in pigs to alleviate the shortage of transplantable human organs (*angrily shakes fist on seatbelt*). There is no word on when such trials would begin as they will be treated on a case-by-case basis, the source said.

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