FDA Set To Allow Pig-Organ Testing in Humans

"The Food and Drug Administration (FDA)  is devising plans to allow clinical trials testing the transplantation of pig organs into humans, a person familiar with the matter said.

If the agency follows through, the trials could be a key step in an effort to ease the deadly shortage of human donor organs. The planning comes in the wake of a handful of experimental surgeries involving the transplantation of pig organs into a critically ill man and in brain-dead patients.

It is unclear when the trials would begin, the person said, adding that proposals from researchers would be handled case by case.

Several research groups have recently sought guidance from the FDA on how to begin clinical trials or plan to seek the agency's approval to launch trials, including those at the University of Alabama at Birmingham and the University of Maryland Medical Center in Baltimore.

Clinical trials allow for the study of larger numbers of patients, robust data collection and strict safety monitoring. In this case, they would likely involve a small number of hospitals with experience with pig-organ transplants, according to transplant doctors.

Doctors at the University of Maryland Medical Center in January transplanted a genetically modified pig heart into David Bennett, a critically ill, 57-year-old handyman from Hagerstown, Md., to extend his life. Mr. Bennett died two months later.

The Maryland researchers received a special FDA emergency authorization to perform the experimental surgery.

About 20 days after the surgery, the heart transplanted into Mr. Bennett was found to harbor a pig virus, researchers reported in June in the New England Journal of Medicine. Whether the virus caused or contributed to Mr. Bennett's death remains under investigation, the researchers said, adding that they felt clinical trials of pig-to-human organ transplantation should begin despite the uncertainty.

The University of Maryland researchers said the agency had previously asked them to conduct additional studies involving baboons before attempting a clinical trial. The scientists are moving forward with those animal studies while seeking FDA guidance about what additional steps might be necessary to open human trials, said Dr. Muhammad M. Mohiuddin, professor of surgery at the University of Maryland School of Medicine and one of the doctors involved in Mr. Bennett's surgery.

Researchers at the University of Alabama at Birmingham plan to seek FDA approval to launch a clinical trial, according to Dr. Jayme Locke, director of the university's Heersink School of Medicine's Comprehensive Transplant Institute.

The Alabama program reported earlier this year that it had transplanted pig kidneys into the body of a brain-dead person, with the organs producing urine before the experiment was stopped.

Transplant doctors and FDA officials discussed possible regulatory requirements for interspecies transplantation, or xenotransplantation, at a two-day public advisory committee meeting convened by the agency Wednesday. The officials raised concerns that pig viruses might be transmitted not only to pig organ recipients but also to their friends and family members as well as the transplant teams." [1]

 

For a long time in Lithuania, there is silence here. Neither do we know how to raise pigs today, nor do we know how to treat people. Lithuanian biotechnology is in Stone Age. The Russian KGB taught us how to produce restriction enzymes. Well, we produce.

 

1. U.S. News: FDA Set To Allow Pig-Organ Testing in Humans
Marcus, Amy Dockser; Whyte, Liz Essley. 
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 July 2022: A.3.