NEW STUDY : PIG KIDNEYS DEMONSTRATE ‘ LIFE-SUSTAINING KIDNEY FUNCTION ’ FOR THE FIRST TIME IN A HUMAN
NEW STUDY : PIG KIDNEYS DEMONSTRATE ‘ LIFE-SUSTAINING KIDNEY FUNCTION ’ FOR THE FIRST TIME IN A HUMAN
For the first time in a human , genetically modified pig kidneys provided “ life-sustaining kidney function ” during the course of a planned sevenday study , all while using current standard-of-care immunosuppression drugs .
The peer-reviewed findings from a study conducted in February 2023 , published in JAMA Surgery in August , extend another pioneering UAB Medicine preclinical human research model study in a recipient experiencing brain death . The study also advanced the science and promise of xenotransplantation as a therapy to potentially cure end-stage kidney disease – just as a human-to-human allotransplant can – and addresses the critical worldwide kidney organ shortage crisis .
“ 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 ,” said UAB transplant surgeon scientist Jayme Locke , M . D ., MPH , director of the UAB Comprehensive Transplant Institute ( CTI ) within the UAB Heersink School of Medicine and lead author of the JAMA Surgery paper . “ 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 .”
Another step forward The published findings are another major xenotransplant achievement by Dr . Locke and her UAB CTI team . They come 19 months after 2022 ’ s groundbreaking , peer-reviewed , and published UAB xenotransplant research study , in which genetically modified pig kidneys were successfully transplanted into a recipient after brain death .
The research has now taken another significant step forward . The study was conducted using the Parsons Model , a preclinical human brain death model developed at UAB to evaluate the safety and feasibility of pig-to-human kidney xenografts , or transplants , without risk to a living human . It is named for transplant pioneer Jim Parsons , an organ donor whose family generously donated his body to advance xenotransplant kidney research . Parsons ’ gift led to the first clinical-grade pig kidney xenograft transplant into a human and helped pave the way for future pig kidney-to-living human transplantation . The current research also was conducted in a person who indicated to his family that he wanted his body donated for research upon his death .
The 52-year-old study subject for this research , not named at the request of his family , lived with hypertension and stage 2 chronic kidney disease , which affects more than one in seven U . S . adults , or an estimated 37 million Americans . As part of this study , the subject had both of his native kidneys removed and dialysis was stopped , followed by crossmatchcompatible xenotransplants with 10 gene-edited pig kidneys , or UKidney™ .
The transplanted pig kidneys made urine within four minutes of reperfusion and produced more than 37 liters of urine in the first 24 hours . The pig kidneys continued to function as they would in a living human for the entirety of the seven-day study . Also , the kidneys were still viable at the time the study was concluded , with a final serum creatinine of 0.9mg / dL and a creatinine clearance of 200 milliliters per minute . Creatinine clearance is the volume of blood plasma cleared of creatinine per unit . Creatinine is a waste product that comes from the normal wear and tear on muscles of the body . By comparison , when the study began and before the pig kidneys were transplanted , the study subject ’ s creatinine measured at 3.9 mg / dL when his native kidneys were removed and dialysis was stopped . Healthy creatinine levels are 0.7-1.2 mg / dL .
The pig kidneys were serially biopsied throughout the course of the study . Biopsies showed normal histology by light microscopy , without evidence of any destruction of red blood cells , low platelets , or organ damage due to the formation of microscopic blood clots in capillaries or small arteries .
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