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 when they successfully transplanted a pig's heart into a human. The 57-year-old patient may have died two months later due to complications from the experimental procedure, but the case has inspired medical scientists to appeal to the FDA to expand the scope and scale of research on human-porcine transplantation. During a two-day conference in late June, FDA policy advisers and healthcare professionals discussed the future of xenotransplantation and "most attendees agreed that human trials are needed." to help answer the most pressing research questions,” according to Nature.

Since the turn of the 19th century, we have been injecting pig organs into sick people, but the technology has made rapid advances in recent decades, in part due to the advent of CRISPR technology and immunosuppressants more powerful. In 2017, researchers created the first human-pig hybrid embryo and developed a solution to potential cross-species viral infections. Since January 2022, successfully implanted genetically modified pig kidneys in brain-dead donor recipients.

"Our goal is not to have a one-time treatment, but to advance the field to help our patients," said Dr. Jayme Locke, lead kidney study surgeon and program director of UAB incompatible kidney transplant. the NYT. "What a wonderful day it will be when I can walk into the clinic and know I have a kidney for anyone waiting to see me."

Humans have also performed many experimental transplants of pig organs into primates like baboons. But to do so safely and consistently with humans, researchers will need to test the techniques on humans, Caroline Zeiss, a veterinary specialist at the Yale School of Medicine, told 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 they won't know for sure without further testing than a primate model - those that cannot be replicated in primates.

Researchers are only considering "small, targeted clinical trials" with "appropriately selected patients," Allan Kirk, a transplant surgeon at Duke University School of Medicine, told Nature. > Researchers will need to answer a number of fundamental questions before the technology can be used widely, as well as determining the right mix of breeding and genetic tinkering needed to ensure recipients' bodies won't reject them.

And while the decisions made at last week's meeting would not immediately impact the agency's current position on xenotransplantation, changes are reportedly afoot. The WSJ spoke in late June with a "person familiar with the matter" who claims the FDA plans to initiate pig organ transplant trials in an effort to ease the shortage of tr ...