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aAn Alabama woman is free from dialysis and in better health after surgeons at NYU Langone Health performed a gene-edited pig kidney transplant last month. The surgery represents the latest promising advance in an emerging surgical practice that is being held out as a solution to the organ supply crisis.
Twana Rooney, 53, donated her kidney to her mother in 1999, but a few years later she developed kidney failure after complications during her pregnancy caused high blood pressure. Less than 1 percent of living donors develop kidney failure, but those who need a transplant are given higher priority on the waiting list. By December 2016, she had to start dialysis treatment to remove excess fluid and waste from her bloodstream. She was put on the kidney transplant candidate list in early 2017, but finding a suitable match proved nearly impossible. Because of the abnormally high levels of harmful antibodies in her blood, a catastrophic transplant rejection was likely. She remained on the transplant waiting list for nearly eight years, gradually losing access to blood vessels to support dialysis.
Given his worsening condition from long-term dialysis and the low likelihood of finding a match after years of searching, Rooney entered the Food and Drug Administration's Expanded Access Program, also known as Compassionate Youth. Based on this, permission was granted to receive 10 gene-edited pig kidneys. The program allows patients to use investigational drugs outside of clinical trials if they develop a life-threatening condition.
Xenotransplantation remains a new frontier in surgery, and there are challenges to overcome. But Rooney is the healthiest he's been in eight years. “It's a blessing,” Rooney said. “I feel It's like I've been given another chance in life. I can't wait to travel again and spend more quality time with my family and grandchildren. ”
Rooney's surgery marks the third time a gene-edited pig kidney has been transplanted into a living human. She was the first person to receive a kidney from a pig with 10 gene edits and is currently the only person in the world living with pig organs.
“We must protect at all costs the heroes who gave the gift of life to others,” said Robert Montgomery, MD, H. Leon Pachter Professor of Surgery, who led the operation. ) said. Dean of New York University Grossman School of Medicine surgery;Director of the Langone Transplant Institute, New York University; “Towana represents the culmination of the progress we have made in xenotransplantation since her first surgery in 2021. She has become a beacon of hope for those battling kidney failure. At this moment New York University Langone, who was involved in the realization of All the doctors, researchers, nurses, administrators and perioperative care team at Luss are so happy for her and proud of what they have done to improve Twana's life through this wonderful treatment. I couldn't be more proud of this scientific achievement.”
Twana Rooney's health has improved since receiving a gene-edited pig kidney transplant at NYU Langone Health, marking a major breakthrough in addressing the organ supply crisis. Rooney, who had been on dialysis for nearly eight years due to kidney failure, received permission to receive a pig kidney under the FDA's Compassionate Use Program.
At home in Alabama, Rooney was originally treated by Jamie Locke, MD, MPH, a transplant surgeon who led the revolution in xenotransplantation while attending the University of Alabama at Birmingham (UAB). Dr. Locke has launched an FDA expanded access application for Looney, which will receive kidneys from pigs with 10 gene edits. At UAB, Dr. Locke conducted several studies to verify whether this organ performs the same life-sustaining functions as the human kidney, thereby providing critical data to the FDA for approval of the emergency application. I was able to.
Dr. Locke worked with her longtime mentor, Dr. Montgomery, to make Rooney's xenotransplant possible. Additionally, Dr. Locke was recently appointed to a new transplant leadership position as Director of the Transplant Division at the U.S. Health Resources and Services Administration.
There are nearly 104,000 people on the transplant waiting list, of which more than 90,400 are waiting for a kidney transplant. According to the Centers for Disease Control and Prevention, more than 1 in 7 adults in the United States, or about 35.5 million people, have chronic kidney disease. The National Institutes of Health estimates that about 808,000 of these people have end-stage kidney disease, but only about 27,000 will receive a kidney transplant in 2023.
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About the procedure
Rooney's surgery is the latest in a series of similar surgeries known as xenotransplants, which involve transplanting organs between species.
The kidney was transplanted into Rooney's lower abdomen on November 25, 2024, at NYU Langone Health in New York City, after a seven-hour surgery co-directed by Dr. Montgomery and Dr. Locke. The organ, known as UKidney, came from a gene-edited pig developed by Revivicor Inc., a subsidiary of United Therapeutics Corporation. The 10 gene edits included removal of three immunogenic antigens (Gal, Sda, and Neu5Gc) and the porcine growth hormone receptor. Six human transgenes were added to increase the compatibility of the gene-edited pig kidney with the human recipient and reduce the chance of rejection. Gene editing, pig breeding, and production of clinical trial UKidney used in this procedure were performed by United Therapeutics and Revivicor. No other unapproved devices or drugs were used in this procedure.
After 11 days of postoperative observation by the New York University Langone Transplant Institute team, Rooney was discharged from the hospital on December 6 and moved into an apartment in New York City. she plans to visit the hospital every day evaluation. As part of acute antibody hypersensitivity treatment, you may be given periodic inpatient medications while your immune system adapts to the new organ.. She plans to return to her home in Alabama within three months.
“Twana is an inspiration. Her journey to achieving a life-sustaining kidney transplant was long and filled with countless obstacles, but she never wavered. She, her family, and the community It is nothing short of miraculous for society to see hope for a future restored that has been out of reach for so long,” Dr. Locke said. “Transplants are one of the few treatments that can cure complex diseases overnight, but there are too few organs to provide a cure to everyone who needs it. NYU Langone Health is a leader in excellence. Towana is the only survivor with a functioning xenograft. Her commitment to innovation is evident, as evidenced by her care team, and we couldn't be more proud of our NYU Langone Health team. The thought that we might be able to solve the organ shortage crisis for others suffering from cancer evokes a very welcome emotion: pure joy.”
Additional xenotransplant investigators included Adam Griesemer, MD; Jeffrey M. Stern, MD. Bonnie E. Ronze, MD. Nicole M. Ali, MD. Sapna Mehta, MD. Vasishta Tatapudi, Maryland. Arajita Mattoo, MD; Edward Y. Skolnik, MD. Dr. Massimo Mangiola;Philip M. Sommer, MD; Finaleti Zervaugh, MD, and Henry J. Newman, MD. Anoma Nellore, MD. Elaina P. Weldon, MSN, NP;Karen Kalil, Pharm.D. Dr. Jacqueline Kim. Ian S. Jaffe; Imad Aljaban, MD; Tal Eitan, MD. Rebecca Esker, Pharm.D. Nikki Lawson, RN. Cecilia Deterville, Mississippi. Dr. Jeff D. Bouquet;Brendan Keating, Ph.D. Dr Simon Williams. Ming Wu, MD; Dr. Ramin Herati; harvey pass maryland; Vinita Kumar, MD; Megan Sykes, MD, director of the Columbia Center for Translational Immunology, and Alexandre Loupy, MD, director of the Paris Institute for Transplantation and Organ Regeneration.
Members of the xenotransplantation team at New York University Langone Transplant Institute
Credit: Joe Carotta
NYU Langone Health is supported by financial support provided to United Therapeutics and the Xenograft Research Initiative to Kidney UK, and by Alexion Pharmaceuticals Inc., which provided ultomiris (also known as ravulizumab-cwvz) to help prevent kidney rejection. Thank you very much. Ultomiris, which is approved for the treatment of certain rare diseases, was made available for use in this experimental procedure through a collaborative research agreement and a compassionate use exception approved by the FDA. As part of Apellis Pharmaceuticals' Compassionate Use Program, the company offered Empaveli, also known as Pegcetacoplan, as an off-label treatment to prevent organ rejection.
Advances in xenotransplantation
This complex intervention was carried out by the New York University Langone Transplant Institute and was the seventh human xenotransplantation directed by Dr. Montgomery, who has spent much of his career researching innovative approaches to expanding organ supply. It will be surgery. On September 25, 2021, he performed the world's first gene-edited pig-to-human organ transplant on a neurologically deceased patient with a beating heart. A similar procedure was carried out on November 22, 2021.
Surgeons at NYU Langone then performed two 10 gene-edited pig heart transplants in the summer of 2022 in neurologically deceased individuals. Last year, a 61-day study of gene-edited pig kidney xenotransplants in recently deceased men showed optimal performance with standard-of-care immunosuppression. In April 2024, Lisa Pisano underwent the first-ever surgery to combine a heart pump transplant with a gene-edited pig kidney transplant. She later died in hospice care on July 7 due to difficulty weaning herself off hospital medications that were being used to maintain blood pressure sufficient to support the xenogeneic kidney.
“This next step in xenotransplantation would not have been possible without the generosity and altruism of those who have participated in our research thus far,” Dr. Montgomery said. “Twana's case portends possible clinical trials under the guidance of the FDA to determine whether these organs are safe as a new sustainable organ source for people in need.”
About New York University Langone Transplant Institute
New York University Langone Transplant Institute has the highest quality kidney and lung transplant programs in the nation, according to high-quality federal data, but its heart and liver transplant programs have the lowest survival rates in the nation. Distinguished in its success in removing patients from waiting lists faster. The institute performs an average of more than 600 organ transplants each year. NYU Langone's Heart, Kidney, Liver, Lung, and Pancreas Transplant Program is approved by the Centers for Medicare and Medicaid Services (CMS) and meets the rigorous quantity, process, quality, and survival outcome requirements of CMS regulations. means fulfilled.
About NYU Langone Health
NYU Langone Health is a world-class, patient-centered, integrated academic medical center rooted in a culture of excellence in patient care, education, and research. Vizient Inc. has ranked New York University Langone the No. 1 comprehensive academic medical center in the nation for the third consecutive year. US News & World Report Nine of its clinical specialties were recently ranked in the top five in the country. NYU Langone provides comprehensive medical services at six inpatient facilities, the Perlmutter Cancer Center, and more than 300 outpatient facilities in the New York region and Florida. With revenue of $14.2 billion this year, the system also includes two medical schools in Manhattan and Long Island and a large research company.
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