Scientists at the University of Maryland Medical Center have successfully transplanted the heart of a genetically modified pig into humans. This was the patient’s only chance to stay alive. The success of the project could mean opening up new opportunities for thousands of people who have been waiting for organ transplants for years. For the emergence of new technology in Russia, a change in regulation will be required, the expert believes.

David Bennett was admitted to a Maryland hospital about six weeks ago. He was diagnosed with life-threatening arrhythmia. Then he was connected to a heart-lung machine.

Due to arrhythmia, Mr. Bennett could not have an arterial pump (artificial heart) implanted, and he could not get on the lists for heart transplantation from another person, since he did not fit the selection criteria. In addition, given that thousands of patients in the United States die every year while waiting for their turn for donor organs, the man had no other options but to wait for death in a hospital bed.

However, the specialists of the University of Maryland Medical Center suggested that the 57-year-old patient get a pig’s heart instead of a human heart – in fact, a scientific experiment that has never been carried out before and the consequences of which are not known to anyone. David Bennett agreed.

“For me, the choice was between death and this transplant,” Bennett said on the eve of the operation. “I understand that this is a step into the unknown, but for me this is the last chance.”

According to the university’s website, the operation was carried out on January 7. It can already be considered successful, as three days later Bennett is doing well, and the pig heart transplant did not cause immediate rejection by the patient’s immune system.

But the final conclusions about the success of the operation can only be made after it becomes clear how long a man will be able to live with a foreign heart. Scientists already have negative experience in this area – the story of little Stephanie Faye Bockler, who was born on October 14, 1984 with left heart syndrome.

These are several heart defects at once, which usually lead to the death of a newborn in a few days. But the girl’s parents were then offered a baboon heart transplant. The operation took place under the guidance of organ transplant specialist Leonard Bailey on October 26.

On the one hand, the results of the operation were impressive – the child survived and lived for two more weeks, that is, longer than any of the adults who had previously tried to have an animal heart transplanted. On the other hand, the alien heart was rejected pretty soon, and the girl died on November 15.

This incident sparked a wave of controversy over the admissibility of such operations. As a result, such operations were almost banned by the US authorities, and to carry them out, you must obtain a special permit from the Food and Drug Administration. This permission was obtained by specialists from the University of Maryland on New Year’s Eve.

In order not to repeat the fate of Faye Boclair’s experimental operation, scientists ordered a genetically modified pig from Revivicor. Three genes responsible for the rapid rejection of pig organs by humans have been removed from the donor pig. Instead, six human genes were inserted into her genome, responsible for the immune perception of the pig’s heart. Finally, another gene was removed from the pig to prevent overgrowth of heart tissue.

Thus, in total, the scientists made ten unique changes to the donor pig’s gene.

Along with conventional anti-rejection drugs, which are designed to suppress the immune system and prevent the body from rejecting a foreign organ, the scientists also used an experimental drug from Kiniksa Pharmaceuticals.

As a result, scientists managed to ensure that Bennett’s body did not reject the alien heart – at least immediately. As noted in a statement from the university, doctors will continue to monitor the condition of David Bennett over the next few weeks.

“This operation is a real breakthrough that brought us one step closer to solving the problem of organ shortages. Donated human hearts are simply not enough to meet the needs of a long list of potential recipients, ”said Bartley Griffith, MD, who directly transplanted a pig’s heart into a patient.

According to the OrganDonor.gov website, in the United States alone, about 100,000 people expect organ donor transplants, and about 6,000 patients die every year without waiting for their turn.

Yaroslav Ashikhmin, a cardiologist and advisor to the General Director of the International Medical Cluster Foundation (Skolkovo), who is engaged in biotechnology, emphasizes that the achievement of American specialists is a major breakthrough in medicine and a potential Nobel Prize. However, he said, it is important to see if all is well with the patient in the long term.

“So far, the results indicate a good engraftment of the organ. If there is no rejection for a long time, then this is a coup. But this is also the way to ensure that medicine is stratified. Just imagine, somewhere they will receive an additional pig’s heart, and in our country there is a monstrous lack of hearts. The Shumakovsky center, Novosibirsk, is actively working, but in general across the country the need is not just not closed, we have a minimum of operations, “the expert told Kommersant.

Mr. Ashikhmin claims that there are specialists in Russia who could produce such technologies, but there are also a number of barriers.

“The problem is that money doesn’t reach those who work with their hands. They end up on equipment, on anything, anything. Besides, the Russian legislation does not allow to do practically anything. The third problem with ordering reagents from abroad. In addition, the certification system in Russia is catastrophically outdated. A laboratory that makes a genetically modified heart cannot meet the standards of a laboratory where blood tests for cholesterol and glucose are done, ”says Yaroslav Ashikhmin.

He emphasizes that serious regulatory changes are needed in Russia: “Otherwise, imagine when Rospotrebnadzor and Roszdravnadzor will allow the export of genetically modified pigs for human heart transplantation, if now we cannot import genetically modified soybeans?”

Kirill Sarkhanyants, Natalia Kostarnova

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