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A 53-year-old woman is free from dialysis after receiving a gene-edited pig kidney transplant at NYU Langone Health, on Tuesday.

The 7-hour surgery was performed on November 25, marking the third time that a kidney from a gene-edited pig has been transplanted into a living human. Recipient Towana Looney, of Alabama, is currently the only individual in the world living with a pig organ and was the first to receive a pig kidney with 10 gene edits.

Looney received the UKidney developed by Revivicor under the leadership of Robert Montgomery, MD, DPhil, director of the NYU Langone Transplant Institute, and Jayme Locke, MD, MPH, director of the Division of Transplantation at the U.S. Health Resources and Services Administration.

The pig kidney had gene edits removing three immunogenic antigens (Gal, Sda, and Neu5Gc) and a porcine growth hormone receptor, plus six human transgenes added to reduce the likelihood of rejection.

"This kidney is remarkable," said Locke. "Right after reperfusion, it began making urine. It functioned essentially exactly like a kidney from a living donor. Her creatinine fell by more than 50% within 24 hours and normalized very quickly. She has normal kidney function today, now 3 weeks out."

"I think this is going to be a good indication of how things are going to go and for people who are in better shape but still don't have really any chance of receiving a human kidney transplant," Montgomery said.

Following an 11-day postsurgical observation period at NYU, Looney was discharged to a nearby apartment on December 6 and now returns to the hospital every day for evaluation. She also wears a health tracker to monitor her physical activity, heart rate, and blood pressure. Looney is expected to return home to Alabama in 3 months.

"I want to go to Disney World," Looney said when asked at a press conference what she wants to do next. "I'm overjoyed ... I am full of energy. Got an appetite I've never had in 8 years. I can go to the bathroom. It's like I can feel the blood pumping through my veins. You can put your hand on my fistula and feel it buzzing. I could put my hand on this kidney and feel it buzzing. It's so strong."

Looney had entered the press conference hooked up to an IV pole, which Montgomery pointed out was to provide her additional medication prompted by recent biopsy results "in order to prevent a rejection from happening."

After donating a kidney to her mother in 1999, Looney developed preeclampsia during pregnancy, leading to high blood pressure, the development of chronic kidney disease, and subsequently kidney failure. She started dialysis in 2016 and was given priority on the transplant waiting list as a living donor. But she remained on the transplant waiting list for almost 8 years after it proved arduous to find a match due to her high levels of antibodies from prior conditions.

Currently, an estimated 104,000 people are on the transplant waiting list -- 90,400 of whom are waiting for a kidney.

The field of xenotransplantation has been advancing recently with the hope that non-human organs can prove to be a viable solution to the organ shortage crisis.

In March, a 62-year-old man with end-stage kidney disease received the world's first successful transplant of a gene-edited pig kidney at Mass General Transplant Center in Boston. Montgomery's team later performed the first-ever combined mechanical heart pump and gene-edited pig kidney transplant surgery in a living patient in April. Both recipients died within a few months of transplant.

Montgomery noted that these two patients are not necessarily predictive of what Looney's outcome will be.

"The last patient we transplant had both heart failure and kidney failure and was really probably days or weeks away from dying and the intention there was just to try to extend life," he explained. "Towana is in much better shape physically. Her disease has not extended to the point where she was at high risk for dying very soon. But she had no clear pathway to a transplant. Rather than waiting for her to develop all of the different comorbidities and problems that people who are on chronic dialysis for long periods of time develop, we caught her at a time when she was starting to lose access for dialysis to her blood vessels."

Looney's procedure was performed under the FDA's expanded access program, also known as "compassionate use," for patients with a potentially fatal condition. Montgomery said he expects more patients like her to be treated through compassionate use in the near future, and that clinical trials will begin "by this time next year or even sooner."

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