US FDA likely to fine-tune clinical trials for pig-to-human organ transplant

The procedure, known as xenotransplantation, dates back to the 17th century, when there were attempts to use animal blood for blood transfusions. Nature explained that due to the lack of organs from humans, scientists began to look at non-human primates like monkeys, chimpanzees and baboons, and even pigs.

Experiments in pigs have shown more positive results as their organs can be compared to those of humans.

While few such procedures were performed in the past year, no formal human xenotransplant trials have been conducted.

Most agency officials and physicians agree that human trials are needed to help answer some of the most pressing research questions about interspecies transplants, the report said.

Information is also needed regarding the breed of pig most suitable for growing transplant organs, and how co-occurring health conditions, such as diabetes, may affect transplant success.

“Human trials will help answer many questions, including what is the best cocktail of immunosuppressive drugs to help humans accept pig organs to their bodies, and how physicians can manage the risk of that.” Transplanted organs can harbor the pig virus,” added Carolyn Zeiss, a veterinary specialist at Yale University.

An increasing number of people awaiting organ transplants are also pushing the need for tests. In the US alone, more than 100,000 people are waiting for organ transplants. Researchers have long hoped that xenotransplantation could help meet demand and, therefore, save lives.

“We have people dying every day waiting for organs,” said Jay Fishman, a specialist in transplant infectious disease at Massachusetts General Hospital in Boston, who attended the FDA meeting.

In September 2021, a study published in the American Journal of Transplantation showed the transplantation of two kidneys of a gene-edited pig into a brain dead patient. The kidneys functioned normally for 54 hours after the test and appeared to be producing urine.

Again in October, doctors at NYU Langone Health, New York, performed a similar surgery.

In January this year, a critically ill person in Maryland, US, became the first person to get a pig heart. However, he died two months later due to a porcine virus, a preventable infection that has been associated with a devastating effect on transplants.

Even though the heart-transplant recipient died, the surgery represents a major achievement, Alan Kirk, a transplant surgeon at Duke University in the US, was quoted as saying.

The high-profile transplant has “raised public awareness of the field” and “made it an optimal time for public conversation” and clinical trials, according to the FDA’s Office of Tissue and Advanced Medicine in Silver Spring, Maryland. Director Wilson Bryan said. I am in the meeting

Companies such as Revivcor in Blacksburg, Virginia, owned by United Therapeutics, have been breeding pigs for use in xenotransplantation.

The report says they are exploring the right combination of genetic modifications for their pigs to help ensure that humans’ immune systems accept organs from animals.

“These companies have been creative in making these pigs; hopefully they will conduct creative tests,” FDA investigator Deborah Hersh said at the meeting.

Disclaimer: This story is auto-aggregated by a computer program and is not created or edited by FreshersLIVE.Publisher : IANS-media

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