In a significant medical breakthrough, genetically modified pig kidneys have demonstrated “life-sustaining kidney function” during a planned seven-day clinical study for the first time. This achievement is a critical step in addressing the worldwide crisis of a shortage of kidney donor organs.
The pioneering research took place at the University of Alabama at Birmingham, advancing the field of xenotransplantation – the transplantation of organs from one species to another. This breakthrough offers hope for addressing end-stage kidney disease, similar to human-to-human kidney transplants.
Director of UAB’s Comprehensive Transplant Institute and lead author of the paper, UAB transplant surgeon scientist Jayme Locke, MD, said, “It has been truly extraordinary to see the first-ever preclinical demonstration that appropriately modified pig kidneys can provide normal, life-sustaining kidney function in a human safely and be achieved using a standard immunosuppression regimen.”
“The kidneys functioned remarkably over the course of this seven-day study. We were able to gather additional safety and scientific information critical to our efforts to seek FDA clearance of a Phase I clinical trial in living humans and hopefully add a new, desperately needed solution to address an organ shortage crisis responsible for tens of thousands of preventable deaths each year,” she said.
The peer-reviewed findings, recently published in JAMA Surgery, describe the groundbreaking pre-clinical human research conducted on a recipient who experienced brain death. This research was carried out by the team at the Locke and Heersink School of Medicine.
It follows a groundbreaking xenotransplant study performed 19 months ago at the University of Alabama, where genetically modified pig kidneys were successfully transplanted into a recipient following brain death.
The pre-clinical human brain death model developed at the University of Alabama can assess the safety and feasibility of pig-to-human kidney xenografts, or transplants, without any risk to a living human. This model is named after transplant pioneer Jim Parsons, who, like the latest patient, generously donated his body to advance xenotransplant kidney research.
A Crucial Need
The need for viable kidney donor organs is critical, with kidney disease claiming more lives annually than breast or prostate cancer. Over 90,000 individuals are currently on the transplant waiting list, while more than 800,000 Americans live with kidney failure, and tragically, 240 Americans on dialysis lose their lives each day. The wait for a deceased donor kidney can stretch up to a decade, resulting in almost 5,000 people dying each year while awaiting a kidney transplant.
Here are Some of the Key Details From This Groundbreaking Study:
The research subject, a 52-year-old individual with hypertension and stage 2 chronic kidney disease, had both of their native kidneys removed, a dialysis was discontinued. They then received a crossmatch-compatible xenotransplant with two 10 gene-edited pig kidneys, known as UKidney.
Remarkably, the transplanted pig kidneys began producing urine within just four minutes of re-perfusion and generated more than 37 liters of urine within the first 24 hours. Throughout the entire seven-day study, the pig kidneys functioned as they would in a living human. Furthermore, they remained viable at the study’s conclusion.
“In the first 24 hours these kidneys made over 37 liters of urine. It was really a remarkable thing to see,” said Dr. Locke.
Biopsies of the pig kidneys taken during the study revealed normal histology without any signs of red blood cell destruction, low platelet counts, or organ damage due to microscopic blood clots in capillaries or small arteries.
Advancements in gene editing of pigs have reduced the risk of immune rejection, making organ transplants from pigs to humans a possibility. Pigs have a natural lifespan of 30 years, are easily bred, and possess organs of similar size to humans. Extensive testing of genetically modified pig kidneys has been conducted in non-human primates.
The addition of the University of Alabama’s preclinical human research model, known as the Parsons Model, has provided crucial insights into the safety and effectiveness of pig kidneys in human transplant recipients.
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