A 53-year-old Alabama woman with kidney failure who waited eight years for an organ transplant has received a kidney harvested from a genetically modified pig, NYU Langone Health surgeons announced on Tuesday.
The patient, Towana Looney, went into surgery just before Thanksgiving. She was in better health than others who have received porcine organs to date and left the hospital 11 days after the procedure.
But Ms. Looney returned on Friday for a series of intravenous infusion treatments. Even before the transplant, she had high levels of antibodies that made it difficult to find a compatible human donor kidney.
The case will be closely watched by the transplant community, as success could speed initiation of a clinical trial, bringing pig transplants closer to reality and helping to solve the organ-supply shortage.
Since the transplant, Ms. Looney has been off dialysis, doctors said, and her blood pressure, stubbornly high for decades despite a cocktail of medications, is now controlled.
The kidney she received started making urine even before she woke from surgery, and blood tests show it is clearing creatinine, a waste product, from her body.
In an interview last week, before she was readmitted to the hospital, she was a bundle of energy.
“I’ve never felt better,” said Ms. Looney, of Gadsden, Ala., describing how easy it had become to do household chores or whip up a meal, arduous undertakings when she was on dialysis.
“I used to do one task, sit down and take a rest, then go do another task. Now I multitask!”
Her appetite, dimmed for years by the nausea that often accompanies dialysis, also came roaring back, and Ms. Looney can eat full meals, not just dabble with soup, she said. (She favors hospital food, an oddity she attributes to many years spent in hospitals.)
She was already planning trips — Disney World is high on the list — that she can now make without worrying about finding dialysis services while she travels.
The next few weeks are critical, said Dr. Robert Montgomery, director of the NYU Langone Transplant Institute.
Dr. Montgomery co-led the surgery with Dr. Jayme Locke, a transplant surgeon who applied two years ago for approval from the Food and Drug Administration to perform the operation for Ms. Looney.
At the time, Dr. Locke was director of the Incompatible Kidney Transplant Program at the University of Alabama at Birmingham.
Finding a compatible human kidney for Ms. Looney was a challenge because the antibodies in her blood, Dr. Locke said, adding, “This was in many ways her only option.”
More than 100,000 Americans with severe organ disease or organ failure are on waiting lists for a human donor organ. The vast majority — over 90,000 — are waiting for a kidney.
But there is an acute shortage of all types of organs. Fewer than 30,000 kidneys, harvested from dead donors or in some cases provided by live donors, are transplanted each year.
Patients on waiting lists represent only a fraction of the more than 550,000 who are on dialysis. Many patients don’t qualify for waiting lists, which screen candidates carefully because organs are in such short supply.
Even those who do qualify often see their health deteriorate while they are on dialysis; only about half survive longer than five years.
Black patients, like Ms. Looney, make up 35 percent of those on dialysis, despite representing only 13.5 percent of the population, partly because of risk factors like high rates of hypertension, diabetes and heart disease.
If animals could be successfully genetically modified so that their organs are less likely to provoke a fierce immune response in the human body, they might be a significant source of vital organs for people in need of transplants.
Ms. Looney is the fifth patient to receive an organ from a genetically modified pig in the United States since 2022, and just the third to receive a kidney. (Two men have received porcine hearts; both died shortly afterward.)
The experimental procedure was approved by the Food and Drug Administration under its expanded access or compassionate use program, which allows unapproved products to be used when patients have life threatening conditions.
The kidney came from a pig with 10 genetic edits. It was provided by Revivicor, a subsidiary of United Therapeutics Corporation, one of at least two companies now producing genetically modified pigs for organ transplantation.
The four earlier patients who received so-called xenotransplants, or an organ from an animal, were much sicker, and their treatment options were limited. The previous organ recipients died within months.
Richard Slayman, 62, of Weymouth, Mass., was the only other recipient who was able to leave the hospital after his surgery. But he had congestive heart failure and died of an apparent cardiac event less than two months after the surgery.
Ms. Looney was healthy enough to be on a waiting list for a human donor kidney and was actually highly ranked, because she had been an organ donor herself. She had given a kidney to her mother in 1999, which gave her precedence.
She was in her 20s at the time and healthy. But when she was pregnant with her second child, in 2002, Ms. Looney developed a life-threatening disorder called pre-eclampsia that left her with uncontrollable high blood pressure after the birth.
High blood pressure damages the kidneys. By 2016, doctors told Ms. Looney that she had to start dialysis, and a social worker convinced her to join the waiting list the following year.
Ms. Looney had seen a television newscast about the early research into the use of porcine organs for humans, and she was captivated by the idea.
“I went to my dialysis social worker and said, ‘You call whoever you need to call and find out how I can get into this program,’” Ms. Looney said.
Over the next few years, she discovered that the odds of finding a compatible human donor kidney were extremely low. She carried unusually high levels of harmful antibodies, which made it likely her immune system would reject an organ.
About two years ago, Dr. Locke contacted Ms. Looney. Dr. Locke was intent on finding better solutions for patients with kidney failure, which is rampant in Alabama and disproportionately affects the state’s Black residents.
It was the beginning of a conversation that spanned nearly two years while the physician sought special F.D.A. permission to do the xenotransplant on Ms. Looney, who was eager to get started.
“I said, ‘OK, where do I sign?’” Ms. Looney recalled.
“But she said, ‘This is new territory. This is new ground. I don’t know what might happen, and a lot of things could go wrong here.’ I said, ‘OK, when are we going to do it?’ And she went through all the if’s and and’s and what might happen again.”
The dialogue continued on and off for months. “We talked every day, and every day we talked she said, ‘Are you sure?’ And I said, ‘I’m positive. My mind is made up,’” Ms. Looney said.
Last month, while Ms. Looney was sitting in her dialysis chair during her morning treatment, her phone rang. It was Dr. Locke, who asked, “How do you feel about flying up to New York?”
Dr. Locke explained that she would do the surgery with Dr. Montgomery, the mentor who trained her.
“I said, ‘But what about Christmas? What about Thanksgiving?’ ” Ms. Looney said.
“She said, ‘It is going to be the best Christmas present you ever got.’ I said, ‘Yes, ma’am, it is.’”
