Surgeons at Massachusetts General Hospital in Boston made history last Saturday with Richard Suleiman. He announced Thursday that he has become the first survivor to receive a genetically engineered kidney from a pig.
Dr. Winfred Williams, a nephrologist and deputy chief of nephrology at Massachusetts General Hospital, said Suleiman, 62, whose kidneys were failing and was on dialysis, spent four hours on Saturday preparing for a pig kidney transplant. He reportedly underwent surgery.
“This is a truly groundbreaking milestone,” William said. “If the kidneys continue to function well and this is successful, I think it will be a breakthrough in many areas.”
The first successful pig kidney transplant into a living recipient is a milestone in the field of so-called xenotransplantation, or animal-to-human transplantation, and is a milestone for the tens of thousands of people in the United States on waiting lists for organ transplants. It can give people hope. , as well as countless others around the world.
More than 100,000 people in the United States are on the transplant waiting list, including those in need of a kidney, according to the United Network for Organ Sharing, a nonprofit organization that manages the nation's organ transplant system. It is said to include approximately 90,000 people.
However, xenotransplantation still carries significant risks.was there There have been two pig-to-human heart transplants in the United States. In both cases, the patients had only two months to live.
Suleiman's surgery was five days ago. He is still recovering at Massachusetts General, but Williams said doctors hope to send him home this weekend unless complications arise.
So far, Williams said, there is no sign that the body's immune system is rejecting the kidney.
“His blood pressure and vital signs are very stable,” he said. “He appears to be on the path to an almost complete recovery.”
Still, doctors are working around the clock taking samples of Suleiman's blood, looking for signs of the dangerous virus that is believed to have killed the man who received the first genetically engineered heart from a pig in 2022.
The question still remains how long the kidneys will last.
“It is important to know whether the xenograft will ultimately be a bridge, meaning it will survive for a short period of time until a human allograft is found, or whether it will be what we call a destination, meaning it will survive. It's going to be very interesting because this person will live the rest of their lives,'' said Dr. Jamie Locke, a transplant surgeon at the University of Alabama at Birmingham Hersink School of Medicine.
Still, “this is a game-changer,” Locke said.
Just once for now
Xenotransplantation is not approved by the Food and Drug Administration. Although touted as a potential solution to the global organ shortage, the procedure could be years away from widespread use as more data is needed.
“What we really want to do is participate in the first clinical trial, where we have multiple patients receiving xenotransplants and several sites participating, to really test our hypothesis and see how safe this is. “We can see how effective it is,” said Dr. Robert Montgomery, director of New York University's Langone Transplant Institute.
Suleiman's transplant was done under the FDA's Compassionate Use Program, which allows patients with serious, life-threatening conditions to receive experimental treatments when there are no other options available.
“This is a one-time transplant,” says Karen Maschke, a researcher at the Hastings Center, a bioethics research institute. He researches ethical, regulatory, and policy issues surrounding the use of new biomedical technologies.
Although Suleiman was unique in being selected for a pig kidney transplant, his condition was not unique. Approximately 800,000 people in the United States have kidney failure and require dialysis, which is often a time-consuming process for patients.
Suleiman received a kidney transplant from a deceased human donor in 2018 after undergoing dialysis for seven years. However, last year the transplant showed signs of failure and her dialysis was restarted.
Williams said putting Suleiman back on the waiting list for a new kidney was an option, but that would require a six- to seven-year wait, during which time it was unclear whether Suleiman would survive. Mr. Williams had his doubts.
“He was in a dire straits,” Williams said.
Dr. Leonardo Riera, chief kidney transplant physician at Massachusetts General Hospital, suggested a pig kidney transplant as another option, Williams said, and Suleiman agreed, adding that he was frustrated with dialysis.
“Our hope is that dialysis will become obsolete,” Riera said at a press conference Thursday.
Riera said the hospital obtained the genetically engineered kidney from EGenesis, a pharmaceutical company based in Cambridge, Massachusetts.
He said the kidney contained a total of 69 gene edits, 10 of which were done to reduce the risk of rejection. His other 59 edits were made to lower the risk of virus transmission.
Pig kidneys are about the same size as human kidneys and “under a microscope, they look exactly like human kidneys,” Riera said. “However, gene editing based on differences between humans and pigs from 80 million years ago has made it possible to have more compatible kidneys.”
Dr. Tatsuo Kawai, the surgeon who performed the surgery, said the operating room erupted in applause when people learned the transplant was a success.
“As soon as blood flow to the kidneys was restored, the kidneys immediately turned pink and started producing urine,” Dr. Kawai said. “It was the most beautiful kidney I've ever seen.”