11 July 2022

Xenotransplantation will not be canceled

The US plans to allow organ transplantation from animals

Svetlana Maslova, Hi-tech+

The American regulator FDA signals its readiness to allow the first clinical trials of xenografts, writes Nature. Experts agree that such studies are necessary to clarify all questions about the use of donated animal organs for human needs and, ultimately, to make the procedure a routine practice.

In the USA alone, more than 100 thousand people are on the waiting list for organ transplantation, but there are catastrophically not enough donors. For many years, scientists have been hoping that xenotransplantation will be able to solve this problem. To date, the results of several procedures where animal organs were transplanted to humans are known. The last unique heart transplant operation, after which the 57-year-old patient lived for two months, had the greatest impact on the speed of decision-making.

The man had incurable heart failure and doctors at the University of Maryland managed to get permission from the FDA to perform an operation using a heart from a genetically modified pig. At that time, the state of health did not allow applying for a heart transplant from a human donor or using auxiliary mechanical systems. The man died for an unexplained reason two months after the operation, although all this time it seemed that he was recovering quickly. So far, the effect of cytomegalovirus in the pig's heart as a potential cause of death is being studied.

From a scientific point of view, the operation was a breakthrough and allowed us to obtain invaluable information that the GM heart of a pig is able to function in the human body while its immune system is suppressed to the required level.

Earlier in 2021, other scientists transplanted GM kidneys from a pig to deceased people - they had no noticeable brain function, but the body was on artificial ventilation. The scientists noted that the transplanted kidneys functioned normally for 54 hours and were able to excrete urine.

Last week, FDA officials, scientists and doctors discussed what it would take to study xenotransplantation in pilot clinical trials. The participants of the meeting agreed that such studies are necessary to clarify all the pitfalls of interspecific transplantation and bring the technology closer to clinical practice.

Probably, in the near future, individual research groups will receive permission to conduct small targeted clinical trials with the participation of strictly selected volunteers.

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