Two brain dead people receive pig heart transplants

Two brain-dead patients in the US have received gene-edited pig heart transplants, as scientists work to improve testing for swine viruses on pig organs and collect data that will help launch clinical trials on the transplant. Organ transplantation from animals to humans.

New process

Scientists at NYU Langone Health (based in New York City), where the studies took place in June and July, say pig hearts were airlifted from a facility hundreds of miles away. and transplanted into two recently brain-dead people, Lawrence Kelly, 72, and Alva Capuano, 64.

Kelly worked as a welder in Beaver Meadows, Pennsylvania, and Capuano was a teacher in New York City.

Mr. Kelly was driving alone when he suffered a heart attack, his fiancée Alice Michael said. Ms. Capuano, who received a kidney transplant from her son years ago, suffered a heart attack while at home, her husband - Richard Capuano - confirmed.

Both were later declared brain dead by doctors and maintained on breathing tubes. Their family has agreed to donate the body to science for research.

In the US, brain death is defined as the irreversible cessation of all brain function, even if heart and lung activity can be maintained mechanically.

The studies by experts at NYU Langone Health focus on collecting data on how the pig's heart works, as well as implementing a range of new strategies to test for and prevent transmission of the virus in pigs.

This is an area that has long been of interest to the US Food and Drug Administration (FDA), and the level of concern increased even further after the death of a man in Maryland who received a pig heart transplant in January. was later found to have a swine virus in it.

In the study, the scientists used a novel infectious disease protocol designed to help ensure that the swine virus was not passed on to study subjects who received modified pig heart transplants or groups of pigs. health care providers participating in the experiments.

According to Nader Moazami, director of heart transplant surgery at NYU Langone Health, who leads the pig heart surgery procedure, the pig hearts were not immediately rejected by the recipient's body and functioned during the three-day study period. . The data has not been published or has not been peer-reviewed.

The NYU Langone facility used to study pig hearts will only be used for future xenotransplant studies, according to the doctor leading the study.

The ability of swine virus in internal organs to cause serious infection or viral infection in recipients and their family members, friends, healthcare providers, and the wider community, is considered one of the major risks in the field of xenotransplant, or interspecies transplants.

This problem arose after the transplant of David Bennett, a 57-year-old man from Hagerstown, Maryland. Mr. Bennett received a gene-edited pig heart transplant at the University of Maryland Medical Center in Baltimore. The transplant is intended to prolong the life of a seriously ill man. This person passed away in March, 60 days after the transplant surgery.

An ultrasound image of a pig's heart after being transplanted into Mr. Bennett.

In-depth study of swine viruses

The FDA, which regulates xenotransplant transplants, placed prevention of zoonotic disease transmission at the top of the agenda during a two-day public advisory committee meeting on xenotransplant convened. practice last month.

The FDA is planning to allow clinical trials to test pig organ transplants into humans, a source familiar with the matter said.

The push for xenotransplant transplants stems from an ongoing shortage of human organs. More than 100,000 people in the US are on the nation's transplant waiting list, according to the United Network for Organ Sharing, a nonprofit that contracts with the federal government to help distribute organs. Accordingly, more than 6,000 people die each year while waiting for an organ transplant.

The pig heart transplant study was conducted at NYU Langone Health.

At the FDA advisory committee session, scientists discussed which diseases in pigs should be tested before transplanting animal organs into humans. In addition to porcine CMV - the virus found in Mr. Bennett's pig's heart - the scientists proposed testing for several common swine viruses, such as porcine lymphatic herpesvirus and porcine circovirus, as well as viruses. Pig endogenous - or PERVs - are found in the genomes of all pigs.

The gene-edited pigs used in two pig heart studies at NYU and in an emergency transplant procedure in Maryland came from Revivicor Inc., a company based in Blacksburg, Virginia.

Scientists have developed their own tests for the swine virus in organ recipients, and are developing a test to determine if a pig has been exposed to CMV even without the virus. Sapna Mehta, Director of Transplant Infectious Diseases Program and Clinical Director of NYU Langone Transplant Institute.

In addition to concerns about the common swine virus, scientists are also worried about the potential risk of unidentified animal viruses, Dr. Mehta said.

Blood sample storage

The expert said blood samples were taken from two individuals who received pig heart transplants and from members of the medical team involved in the study. These samples are being archived so that if new swine viruses are identified years from now, researchers can test them and track down anyone who may have been exposed.

Transplant infectious disease experts are putting together a 'white paper' that suggests ways to monitor the potential for viral infection in pigs and transplant recipients, said Dr Jay Fishman, Transplant Infectious Disease Program Manager graft and host injury at Massachusetts General Hospital.

Muhammad M. Mohiuddin, a professor of surgery at the University of Maryland School of Medicine and one of the doctors involved in Bennett's surgery, said scientists continue to study Bennett's case to understand the role he played. of the swine virus in the heart transplanted in this person's death.

Doctors at NYU Langone Health prepared pig hearts for transplant last week.

The scientists went back to the blood samples they stored and used more sensitive tests, which can detect the presence of the virus, Dr. Mohiuddin said. They also re-examined samples from baboons that received pig hearts and picked out some previous viral infections that had been missed in the experiments.

The new data will be part of their discussions with the FDA later this summer to seek guidance from the agency on what additional steps may be needed to open human trials, Dr. .

In the NYU experiments, a special research oversight board at NYU reviewed and approved the procedures, and the researchers conducted them only after consulting with the New York State Department of Health. York, said implant surgeon Moazami.

As a precaution against any possible infection, the operating room, equipment and instruments used in the pig heart study will only be used for future xenotransplant studies, Dr. Moazami said. He further noted that these steps are necessary because the potential transmissibility of the swine virus is also a public health issue.

'If this can be applied to a large number of patients around the world, it is the only way for the public to trust the process,' he stressed.