In an unprecedented procedure, a terminally ill patient received a gene-edited pig kidney transplant and also became the first patient in the world to be surgically implanted with a mechanical heart pump.
Surgeons at NYU Langone Health in New York City performed the surgery in two stages, the first being the implantation of a heart pump. The second transplant, which took place a few days later, included a genetically modified pig kidney to prevent rejection and a pig thymus gland, which produces white blood cells that help the immune system fight disease.
The patient, 54-year-old Lisa Pisano from New Jersey, had heart failure and end-stage renal disease, New York University Langone College said Wednesday. The hospital said she was not a candidate for a heart or kidney transplant because of several chronic conditions, including being on dialysis.
In addition, Pisano has high levels of antibodies that are harmful to human tissue, making it difficult to find a match for a human kidney transplant, the hospital said. However, these antibodies were not harmful to the organs of the gene-edited pigs.
“All I want is the chance to live a better life,” Pisano said in a statement. “After being ruled out for a human transplant, I knew I didn't have much time left. Doctors told me I might be approved for a gene-edited pig kidney transplant. I thought about it and consulted it with my family and my husband.
Lisa Pisano and her granddaughter Olivia Pisano had heart and kidney failure. She was not a candidate for a transplant due to several chronic conditions. However, the FDA cleared Pisano to donate the LVAD and genetically engineered pig kidneys.
Courtesy of Lisa Pisano and family.
The New York University team said they believe this is the first documented case of a patient fitted with a mechanical heart pump receiving any kind of organ transplant. Additionally, the hospital said this is the second time a gene-edited pig kidney has been transplanted into a living human, and the first to be combined with a thymus gland.
The first case occurred last month when a surgical team at Massachusetts General Hospital connected blood vessels and ureters in a pig's kidneys to those of Richard Suleiman, a 62-year-old man living with end-stage renal disease. According to the hospital, he is continuing to make a good recovery.
Pisano's two surgeries were performed by different surgical teams about nine days apart. The first, on April 4, involves the surgical insertion of a device called a left ventricular assist device (LVAD), which helps pump blood from the lower left ventricle to the rest of the body.
NYU Langone says it is typically used in patients who are waiting for a heart transplant or are not eligible for one. The hospital added that without the LVAD, Pisano would only have days or weeks to live.
Doctors say patients with end-stage kidney disease typically cannot receive an LVAD, but a new approach using gene-edited pig kidneys helped get her surgery approved.
“Without the possibility of a kidney transplant, she would not have been an eligible candidate for an LVAD, as the mortality rate for patients undergoing dialysis using a heart pump is high,” said the Department of Heart and Lung Transplantation. Director Dr. Nader Moazami said. Mechanical Circulatory Support, Department of Cardiothoracic Surgery, New York University Grossman School of Medicine. He was one of the doctors who performed the LVAD surgery.
“This unique approach marks the first time in the world that LVAD surgery has been performed on a dialysis patient planning a kidney transplant. The measure of success is the chance for a better quality of life, and we believe that Lisa will continue to Give more time. Spend time with your family,” Moazami continued.
Doctors say a single genetic modification has been made in the pig's kidneys to “knock out” a gene that produces a sugar known as alpha-gal. According to research, Removal of alpha-gal could prevent rejection of xenotransplanted and non-human organs.
“By using pigs with a single genetic modification, we can better understand how one important stable change in the genome can play a role in making xenotransplantation a viable option. I understand,” said Dr. Robert Montgomery, who led the transplant operation and is the division's chief. He is a professor of surgery and director of New York University's Langone Transplant Institute, said in a statement.
“Because these pigs are fertile and do not require cloning like more complex gene editing, this is a sustainable and scalable solution to organ shortages. If you want to start saving quickly, fewer modifications and fewer drugs may be the answer,'' Montgomery said.
Daughter Brittany Harville and Lisa Pisano_1 Lisa Pisano, 54, became the first person to undergo surgery that combines a heart pump with a pig kidney transplant. Photo: Ms. Pisano (right) and her daughter Brittany Havill (left), undated.
Courtesy of Lisa Pisano and family.
Pisano's two-step procedure required clearance from New York University Langone's Institutional Review Board and approval from the Food and Drug Administration. “Compassionate Use” ProgramThis often allows the use of nontraditional methods when a patient has a serious or life-threatening condition.
The xenotransplant was performed on April 11, and Pisano continues to make a good recovery, the hospital said.
Last year, researchers at NYU Langone Health in New York Citycarried outA two-month study of a genetically engineered pig kidney that was transplanted into a 58-year-old man declared brain dead with the consent of his family. The research team observed only mild rejection, which required increased immunosuppressant medication to reverse the rejection.
Experts have expressed hope that being able to transplant animal organs into human patients will help in the future organ supply.
The agency says more than 103,000 men, women and children are currently on transplant waiting lists nationwide.Management of medical resources and services (HRSA), an agency of the Department of Health and Human Services. According to HRSA, 17 people die every day waiting for a transplant, and someone is added to the transplant list every eight minutes.
Dr. Jeffrey Stern, assistant professor of surgery at New York University's Grossman School of Medicine, and Dr. Robert Montgomery, chief of surgery and director of the NYU Langone Transplant Institute, are preparing gene-edited pig kidneys with thymus glands. The transplant will take place in Pisano on April 12, 2024, at NYU Langone Health's Kimmel Pavilion.
Joe Carotta, NYU Langone Health
Additionally, many donor organs, including kidneys, are needlessly discarded each year. research result.If this type of kidney transplant proves effective and safe, it may someday become a reality.Eliminate the need for dialysis According to the National Kidney Foundation, more than 500,000 people in the United States need a kidney to survive.
“It's incredible to think about the scientific achievements that led to our ability to save Lisa's life and what we as a society are going to do for everyone who needs life-saving organs.” Montgomery said.
But edited animal organs raise questions about whether they will function long-term, whether they are safe, and whether animals can be raised ethically for human organ transplantation.
