Last month, Towana Looney became the fifth American to get a gene-edited pig organ. Her operation marks the third time a kidney from a gene-edited pig has been transplanted into a living human. Previous transplants have been for people who were brain dead or at high danger of death within months.
Looney’s steady recovery has sparked hope that one day pig kidneys could help alleviate the ongoing organ shortage.
She told the Associated Press, “It’s like a new beginning. The energy I had was amazing. To have a working kidney — and to feel it — is unbelievable.”
Looney’s need for a kidney stems from a long medical history. She gave a kidney to her mother in 1999, but she suffered damage to her remaining kidney due to high blood pressure during pregnancy. Although kidney failure is unusual in living donors, individuals who do have it are given priority on the transplant waiting list, according to experts.
The Alabama woman was unable to find a match because she had grown antibodies that were abnormally able to attack another human kidney. Tests revealed that she would reject any kidney donated by donors.
She later learned about pig kidney studies at the University of Alabama at Birmingham and approached Dr. Jayme Locke, who would be her original surgeon after being a UAB transplant specialist at the time.
Locke filed an FDA application in April 2023, requesting an emergency experiment under guidelines that apply to persons like Looney who had no other options. The FDA did not agree immediately.
Rather, two sicker patients at NYU and Massachusetts General Hospital received the first kidney transplants from gene-edited pigs last spring. They both suffered from severe heart conditions.
The Boston patient made enough progress to stay at home for about a month before passing away from an unexpected cardiac arrest that was thought to be unrelated to the pig kidney. NYU’s patient died after suffering heart issues that destroyed her pig kidney and forced its removal.
Looney was beginning to feel worse on dialysis but, according to Locke, hadn’t developed heart disease or other health issues. She also wasn’t deterred by the negative results of the two sicker patients.
The 53-year-old reasoned that even if her new organ failed, surgeons could still learn from it. She told AP, “You don’t know if it’s going to work or not until you try.”
In the end, the FDA approved her transplant at NYU, where Locke worked with NYU Langone Health’s Dr. Robert Montgomery, who oversaw the extremely experimental process for the transplant on November 25.
Blacksburg, Virginia-based Revivicor gave Looney a new kidney from a pig that had 10 gene modifications. The kidney turned a healthy pink and started to produce urine just a few minutes after Montgomery stitched it into place.
On December 6, Looney was released from the hospital, where she resumed daily check-ups prior to her medication readmission. She wore monitors to track her heart rate, blood pressure, and other physiological processes. Doctors examine her bloodwork and other tests, comparing them to previous animal and human studies in the aim of detecting irregularities early on.
Montgomery observed, “A lot of what we’re seeing, we’re seeing for the first time.”
When questioned about the next steps, Montgomery said he’s confident there will be more patients like Looney through the FDA’s extended access or compassionate use program, and clinical trials would begin “probably by this time next year, or even sooner.”
“Our challenge is to learn how to support these kidneys for longer periods of time so that they become a reasonable alternative for this scarce, highly rationed supply of human organs,” Montgomery added.
Although Looney was released from the hospital just eleven days after the operation to continue her recuperation in a nearby apartment, she was readmitted this week for a brief stay while her medication was adjusted.
Doctors predict she will return to Alabama in three months. If the pig kidney failed, she could start dialysis again.
In a press conference on Tuesday, she said that she feels “blessed” to have received “a second chance at life.”
“I want to give courage to those on dialysis,” she remarked. “It’s not easy, and it’s not the only option. There’s hope,” she said, according to Good Morning America.