Surgeons Transplant Pig Kidney Into a Patient, a Medical Milestone

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Surgeons Transplant Pig Kidney Into a Patient, a Medical Milestone​

The man continues to improve, doctors said. Organs from genetically engineered pigs one day may make dialysis obsolete.

Surgeons hunch over a patient during an operation.

Surgeons performed the world’s first genetically modified pig kidney transplant into a living human at Massachusetts General Hospital on March 16.Credit...Michelle Rose/Massachusetts General Hospital, via Agence France-Presse — Getty Images

By Roni Caryn Rabin

March 21, 2024Updated 11:28 a.m. ET

Surgeons in Boston have transplanted a kidney from a genetically engineered pig into an ailing 62-year-old man, the first procedure of its kind. If successful, the breakthrough offers hope to hundreds of thousands of Americans whose kidneys have failed.

So far, the signs are promising.

Kidneys remove waste products and excess fluid from the blood. The new kidney began producing urine shortly after the surgery last weekend and the patient’s condition continues to improve, according to physicians at Massachusetts General Hospital, known as Mass General. He is already walking the halls of the hospital and may be discharged soon.

The patient is a Black man, and the procedure may have special significance for Black patients, who suffer high rates of end-stage kidney disease.

A new source of kidneys “could solve an intractable problem in the field — the inadequate access of minority patients to kidney transplants,” said Dr. Winfred Williams, associate chief of the nephrology division at Mass General and the patient’s primary kidney doctor.

If kidneys from genetically modified animals can be transplanted on a large scale, dialysis “will become obsolete,” said Dr. Leonardo V. Riella, medical director for kidney transplantation at Mass General. The hospital’s parent organization, Mass General Brigham, developed the transplant program.

Over 800,000 Americans have kidney failure and require dialysis, a procedure that filters toxins from the blood. Over 100,000 are on a waiting list to receive a transplanted kidney from a living or dead human donor.

In addition, tens of millions of Americans have chronic kidney disease, which can lead to organ failure.

While dialysis keeps people alive, the gold-standard treatment is an organ transplant. Thousands of patients die annually while waiting for a kidney, however, because there is an acute shortage of organs. Just 25,000 kidney transplants are performed each year.

Xenotransplantation — the implantation of an animal’s organ into a human — has for decades been proposed as a potential solution that could make kidneys much more widely available. But the human immune system rejects foreign tissue, causing life-threatening complications, and experts note that long-term rejection can occur even when donors are well matched.


In recent years, scientific advances including gene editing and cloning have edged xenotransplants closer to reality, making it possible to modify animal genes to make the organs more compatible and less likely to be rejected by the immune system.

The kidney came from a pig engineered by the biotech company eGenesis, which removed three genes involved in potential rejection of the organ. In addition, seven human genes were inserted to enhance human compatibility. Pigs carry retroviruses that may infect humans, and the company also inactivated the pathogens.

In September 2021, surgeons at NYU Langone Health in New York attached a kidney from a genetically modified pig to a brain-dead man and watched as it began to function and make urine. Shortly afterward, scientists at the University of Alabama at Birmingham announced they had performed a similar procedure with similar results.

Surgeons at the University of Maryland have twice transplanted hearts from genetically modified pigs into patients with heart disease. While the organs functioned and the first did not appear to be rejected, both of the patients, who had advanced disease, died shortly afterward.

(Patients who agree to these cutting-edge experimental treatments are usually extremely ill and have few options available; often they are too sick to qualify for the waiting list for a precious human organ or are not eligible for other reasons.)

The transplant patient in Boston, Richard “Rick” Slayman, a state transportation department supervisor, had suffered from diabetes and hypertension for many years, and had been under treatment at Mass General for over a decade.

After his kidneys failed, Mr. Slayman was on dialysis for seven years, eventually receiving a human kidney in 2018. But the donated organ failed within five years, and he developed other complications, including congestive heart failure, Dr. Williams said.

When Mr. Slayman resumed dialysis in 2023, he experienced severe vascular complications — his blood vessels were clotting and failing — and he needed recurrent hospitalization, Dr. Williams said.

Mr. Slayman, who kept working despite his health problems, faced a long wait for another human kidney, and “he was growing despondent,” Dr. Williams said. “He said, ‘I just can’t go on like this. I can’t keep doing this.’ I started to think about extraordinary measures we could take.”

“He would have had to wait five to six years for a human kidney. He would not have been able to survive it,” Dr. Williams added.

When Dr. Williams asked Mr. Slayman about receiving a pig’s kidney, Mr. Slayman had many questions but eventually decided to proceed.

“I saw it not only as a way to help me, but a way to provide hope for thousands of people who need a transplant to survive,” he said in a statement provided by Mass General.

Mr. Slayman’s new kidney seems to be functional, so far, and he has been able to stop dialysis. The new pig kidney is making urine and filtering out creatinine, a waste product.

Other measures are also improving daily, his doctors said. Doctors will continue to monitor Mr. Slayman for signs of organ rejection.

“He looks like his own self. It’s remarkable,” Dr. Williams said.

The surgery was not without critics. Xenotransplantation raises the prospect of still greater exploitation of animals and may introduce new pathogens into human populations, said Kathy Guillermo, senior vice president at People for the Ethical Treatment of Animals.

“Using pigs as a source of spare parts is dangerous to the human patients, deadly for the animals and may bring about the next pandemic,” she said. “It’s impossible to eliminate, or even identify, all the viruses that pigs carry. Researchers need to focus on cleaning up the organ donation system and leave the animals alone.”

The four-hour operation was carried out by a team of surgeons, including Dr. Tatsuo Kawai, director of the Legorreta Center for Clinical Transplant Tolerance at Mass General, and Dr. Nahel Elias.

The procedure was performed under a Food and Drug Administration protocol known as a compassionate use provision, which is granted to patients with life-threatening illness who might benefit from an unapproved treatment. New drugs to suppress the immune system and prevent rejection of the organ were also used under the protocol.

“He’s remarkably courageous to step forward,” Dr. Williams said of Mr. Slayman. “Hats off to him. He’s making a huge contribution with this.”

A correction was made on

March 21, 2024

:

An earlier version of this article misstated the kidney’s function regarding creatinine. The kidney removes the substance from the blood; the organ does not create creatinine.
 

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First person to receive a genetically modified pig kidney transplant dies almost 2 months later​

Richard “Rick” Slayman had the transplant at Massachusetts General Hospital in March at the age of 62.

animal to human transplant genetically modified organ

A genetically modified pig kidney is prepared for surgery into Rick Slayman in March.Michelle Rose / Mass General

May 12, 2024, 5:02 AM EDT / Source: The Associated Press

By The Associated Press

The first recipient of a genetically modified pig kidney transplant has died nearly two months after he underwent the procedure, his family and the hospital that performed the surgery said Saturday.

Richard “Rick” Slayman had the transplant at Massachusetts General Hospital in March at the age of 62. Surgeons said they believed the pig kidney would last for at least two years.

The transplant team at Massachusetts General Hospital said in a statement it was deeply saddened by Slayman’s passing and offered condolences to his family. They said they didn’t have any indication that he died as a result of the transplant.

The Weymouth, Massachusetts, man was the first living person to have the procedure. Previously, pig kidneys had been temporarily transplanted into brain-dead donors. Two men received heart transplants from pigs, although both died within months.

Slayman had a kidney transplant at the hospital in 2018, but he had to go back on dialysis last year when it showed signs of failure. When dialysis complications arose requiring frequent procedures, his doctors suggested a pig kidney transplant.

In a statement, Slayman’s family thanked his doctors.

“Their enormous efforts leading the xenotransplant gave our family seven more weeks with Rick, and our memories made during that time will remain in our minds and hearts,” the statement said.

They said Slayman underwent the surgery in part to provide hope for the thousands of people who need a transplant to survive.

“Rick accomplished that goal and his hope and optimism will endure forever,” the statement said.

Xenotransplantation refers to healing human patients with cells, tissues or organs from animals. Such efforts long failed because the human immune system immediately destroyed foreign animal tissue. Recent attempts have involved pigs that have been modified so their organs are more humanlike.

More than 100,000 people are on the national waiting list for a transplant, most of them kidney patients, and thousands die every year before their turn comes.
 

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A U.S. farm breeds pigs for human kidney transplants​

Agence France-Presse

December 17, 2024 11:16AM ET

A U.S. farm breeds pigs for human kidney transplants

Young genetically altered pigs walk past a ball in their pens at the Revivicor research farm in Blacksburg, Virginia on November 20, 2024 (Andrew Caballero-Reynolds/AFP)

by Ulysse BELLIER

On a farm in the southern U.S. state of Virginia, David Ayares and his research teams are breeding genetically modified pigs to transplant their organs into human patients.

Revivicor, the biotech company Ayares leads, is at the forefront of xenotransplantation research -- the implantation of animal organs into humans -- which aims to solve a chronic organ shortage that has thousands of Americans dying each year.

It was on this farm that Revivicor bred a pig whose kidney was recently transplanted into patient Towana Looney, according to an announcement made Tuesday by a New York hospital.

"It's just an exciting time," Ayares told AFP during a recent tour of the research farm.

The pigs are genetically modified to make their organs less likely to be rejected by patients' immune systems.

"These pigs are not typical farm pigs," said Ayares, as he cradled several pink piglets in his arms. "Millions of dollars have gone into the production of these genetics, and so they're very high-value animals."

The kidneys may one day sell for $1 million.

For more than 20 years, Revivicor in Blacksburg, Virginia has been conducting research to turn pig-to-human transplantation from science fiction to life-saving medical care.

In the United States alone, more than 100,000 people are on the transplant list and thousands die every year waiting, most often for a kidney, according to health authorities.


- 'Little room for recognition' -​




AFP For more than 20 years, Revivicor, in Blacksburg, Virginia, has been conducting research to turn pig-to-human transplantation from science fiction to life-saving medical care

Since 2021, several US surgeons have successfully transplanted genetically modified pig kidneys and hearts into humans, most of them supplied by Revivicor. Another key provider is the biotech firm eGenesis.

The first trials were carried out on brain-dead people, before the procedure was attempted on a handful of seriously ill patients.

While those patients died within weeks of the operation, the animal organs they received were not immediately rejected by their immune systems, which scientists hailed as a promising sign.

In a dark laboratory several kilometers away from the research farm, Todd Vaught, head of cell biology at Revivicor, has his eyes glued to a microscope.

With a pipette, he pierces a pig egg to remove its DNA and replace it with cells that have "all the instructions needed to make a genetically modified pig."

A few hours later, the edited eggs are implanted into sows. Four months later new litters are born.

While xenotransplantation research is happening in various parts of the world, the United States is a clear leader in the field.




AFP Scientist Anneke Walters sorts through oocytes -- cells in the ovaries -- being prepared for genetic modification

French sociologist Catherine Rene criticized what she characterizes as mistreatment of the pigs as merely vessels for organs destined for humans.

"Ultimately, there is very little room for recognition of the donor animal, of the gift that is made," Rene told AFP.

Ayares disagreed.

"Hundreds of millions of pigs are used every year as food," Ayares said. "I would argue that this is a much higher calling for that pig organ to be used for transplantation."


- Million dollar price tag -​




AFP DNA is removed from an oocyte before being injected with genetic modifications at the Revivicor Laboratories, in Blacksburg, Virginia, on November 22, 2024

The first line of pigs developed by Revivicor carried only one genome edit meant to deactivate the animal's production of a substance that causes people to reject the transplanted organ.

The second has 10 modified genes, six of which come from human DNA in order to improve biological compatibility.

It is with this second line of pigs that United Therapeutics (UT), Revivicor's parent company, is thinking big.

In March, the publicly traded company opened another medical facility near Blacksburg where, in a brand-new operating room, pigs' kidneys will be removed and prepared for transfer to the receiving patient.

The rest of the pig will be discarded.

Spokesman Dewey Steadman said the facility has "rigorous controls" in place to prevent any infection of the 200 animals being kept there.

The company's goal is to begin several years of clinical studies on patients in 2025 and, if the Food and Drug Administration gives the green light, to begin full-scale production of genetically modified pigs in 2029.




AFP The surgical room at a United Therapeutics facility in Christiansburg, Virginia, is designed to operate on specially genetically altered pigs

UT is already planning to invest billions of dollars into building more and bigger facilities.

The company is considering selling kidneys for around $1 million each, which is close to the cost of 10 years of dialysis for patients in the United States, according to Steadman.

Making pig kidneys available to a large number of patients will not be an easy task in the United States, which lacks universal health care.

But Ayares hopes that with health insurance, "the patient is not bearing a million dollars... price tag."
 

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'Blessed': US Woman Sees Second Chance In Life After Pig Kidney Transplant​




By Issam AHMED
December 17, 2024


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ADDS quote from National Kidney Foundation

Towana Looney donated a kidney to her mother in 1999 only for the remaining one to fail years later due to pregnancy complications.

Now, the 53-year-old from Alabama has become the latest recipient of a gene-edited pig kidney -- and is currently the only living person in the world with an animal organ transplant, New York's NYU Langone hospital announced Tuesday.

"I'm overjoyed, I'm blessed to have received this gift, this second chance at life," Looney said during a press conference, held three weeks after the procedure.

Xenotransplantation, transplanting organs from one species to another, has long been a tantalizing yet elusive scientific goal. Early experiments on primates faltered, but recent advances in gene editing and immune system management have brought the dream closer to reality.

Pigs have emerged as the ideal donors: they grow quickly, produce large litters and are already part of the human food supply.

Advocates hope this approach can help address the severe organ shortage in the United States, where more than 100,000 people are waiting for transplants, including over 90,000 in need of kidneys.

Looney had been living with dialysis since December 2016 -- eight grueling years. High blood pressure caused by preeclampsia had taken its toll, leaving her with chronic kidney disease.

Despite receiving priority on transplant waiting lists as a living donor, her search for a compatible kidney was a frustrating dead end. Her unusually high levels of harmful antibodies made rejection almost inevitable, and as her body lost viable blood vessels to support dialysis, her health declined.

Out of options, Looney applied to join a clinical trial for pig kidney transplants, and finally underwent the seven-hour surgery on November 25.

Asked how she felt afterward, Looney's joy was infectious. "I'm full of energy, I've got an appetite... and of course, I can go to the bathroom. I haven't been going in eight years!" she laughed, adding that she plans to celebrate at Disney World.

Jayme Locke, a surgeon on the transplant team, described the results with awe. "The kidney functioned essentially exactly like a kidney from a living donor," she said, adding that Looney's husband saw a rosiness in her cheeks for the first time in years.

"That is the miracle of transplantation."

Looney's surgery is the third time a gene-edited pig kidney has been transplanted into a human who is not brain dead.

Rick Slayman, the first recipient, died in May, two months after his procedure at Massachusetts General Hospital. The second, Lisa Pisano, initially showed signs of recovery following her surgery at NYU Langone, but the organ had to be removed after 47 days, and she passed away in July.

Looney, however, was not terminally ill before the transplant, noted Robert Montgomery, who led the surgery. Each case, he emphasized, provides critical lessons for refining the techniques.

The kidney was provided by biotech company Revivicor, which breeds genetically modified herds in Virginia. A Massachusetts-based company, eGenesis, provided the kidney for Slayman.

Looney's organ has 10 genetic edits to improve compatibility with the human body -- an advance over Revivicor's earlier efforts that used kidneys with a single gene edit and included the pig's thymus gland to help train the host's immune system and prevent rejection.

Montgomery, a pioneer in the field who performed the world's first gene-edited pig organ transplant in a brain-dead patient in 2021, said both methods are likely to enter clinical trials "probably by this time next year, or even sooner."

"This is a watershed moment for the future of transplantation," said Kevin Longino, CEO of the National Kidney Foundation. The nonprofit's polling shows that patients and families favor faster clinical trial progress, believing the risk of inaction outweighs the uncertainties of xenotransplantation.

Looney was discharged December 6 to a nearby New York City apartment. Though her high antibody levels remain a concern, doctors are monitoring her closely using wearable technology and are trying a novel drug regimen to prevent rejection.

Periodic hospital visits may still be required, but the team remains optimistic she can return home in three months.
 
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