INNOVATION
INNOVATION
How long is it expected to take for necessary approvals to be granted ? The timeline depends on interactions with the FDA and the IRB about a clinical path forward . “ We feel that we should pursue the fastest and safest path forward to bring these groundbreaking technologies to patients in need ,” Dr . Locke says . “ We are hopeful that we can begin the Phase I clinical trial in humans soon .”
ABOUT THE XENO STUDY
The peer-reviewed research is a study of ambitious scope and great significance , given that more than 800,000 Americans are living with kidney failure . Most never make it to the waiting list , and far too few human organs are available to put a dent in that number .
Are there any potential dangers of using an animal organ in a human , and is the process sanitary ? This is a sanitary process , as the pigs are raised in a pathogen-free facility . Additionally , the modification of the pig ’ s genes makes their organs less likely to be rejected by human recipients . The risk of infections like porcine retrovirus ( a pig virus that may be transmitted to humans ) is considered to be very low . “ Revivicor pig lines are bred to be free of PERV C , so we see little chance of a PERV A x PERV C recombination event infecting human patients ,” Dr . Locke says . “ The FDA , going back 10 years , has embraced this as sufficient .”
Dialysis can sustain patients for some time , but transplantation offers a longer and better quality of life for the few who can get it . Each stage of this decedent xenotransplant study approximated the steps that might be taken in a Phase I clinical trial :
• The kidneys were removed from a donor pig housed at a pathogenfree , surgically clean facility . The kidneys were then stored , transported , and processed for implantation , just as human kidneys are .
• Before surgery , the brain-dead recipient and donor animal underwent a crossmatch compatibility test to determine whether the genetically modified pig kidney and its intended recipient were a good tissue match . A crossmatch is done for every human-to-human kidney transplant ; however , this pig-to-human tissue match test was developed at UAB and marked the first time a prospective crossmatch has been validated between the two species .
• The pig kidneys were placed in the exact anatomic locations used for human donor kidneys , with the same attachments to the renal artery , renal vein , and the ureter that carries urine from the kidney to the bladder .
• The brain-dead recipient received standard immune-suppression therapy used in human-to-human kidney allotransplantation .
The study was conducted to meet the standards directly comparable to those that would apply to a Phase I human clinical trial , mirroring every step of a standard transplant between humans . It included IRB and Institutional Animal Care and Use Committee approval ; a tissue compatibility confirmation before starting the operations ; the standard procedures of human-to-human transplants for removing , preserving , transporting , and transplanting the kidneys into a human ; and giving the recipient standard immunosuppression therapy .
12 UAB CTI Report