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Wide-eyed piglets rushing to check out the visitors to their unusual barn just might represent the\u00a0future<\/a>\u00a0of organ transplantation \u2013 and there\u2019s no rolling around in the mud here.<\/p>\n The\u00a0first gene-edited pig organs<\/a>\u00a0ever transplanted into people came from animals born on this special research farm in the Blue Ridge mountains \u2013 behind locked gates, where entry requires washing down your vehicle, swapping your clothes for medical scrubs and stepping into tubs of disinfectant to clean your boots between each air-conditioned barn.<\/p>\n \u201cThese are precious animals,\u201d said David Ayares of Revivicor Inc., who spent decades learning to clone pigs with just the right genetic changes to allow\u00a0those first audacious experiments<\/a>.<\/p>\n The biosecurity gets even tighter just a few miles away in Christiansburg, Virginia, where a new herd is being raised \u2013 pigs expected to supply organs for formal studies of animal-to-human transplantation as soon as next year.<\/p>\n This massive first-of-its-kind building bears no resemblance to a farm. It\u2019s more like a pharmaceutical plant. And part of it is closed to all but certain carefully chosen employees who take a timed shower, don company-provided clothes and shoes, and then enter an enclave where piglets are growing up.<\/p>\n Behind that protective barrier are some of the world\u2019s cleanest pigs. They breathe air and drink water that\u2019s better filtered against contaminants than what\u2019s required for people. Even their feed gets disinfected \u2013 all to prevent them from picking up any possible infections that might ultimately harm a transplant recipient.<\/p>\n \u201cWe designed this facility to protect the pigs against contamination from the environment and from people,\u201d said Matthew VonEsch of United Therapeutics, Revivicor\u2019s parent company. \u201cEvery person that enters this building is a possible pathogen risk.\u201d<\/p>\n The Associated Press got a peek at what it takes to clone and raise designer pigs for their organs \u2013 including a $75 million \u201cdesignated pathogen-free facility\u201d built to meet Food and Drug Administration safety standards for xenotransplantation.<\/p>\n Thousands of Americans each year\u00a0die waiting<\/a>\u00a0for a transplant, and many experts acknowledge there never will be enough human donors to meet the need.<\/p>\n Animals offer the tantalizing promise of a ready-made supply. After decades of failed attempts, companies including Revivicor,\u00a0eGenesis<\/a>\u00a0and Makana Therapeutics are engineering pigs to be more humanlike.<\/p>\n So far in the U.S. there have been four \u201ccompassionate use\u201d transplants, last-ditch experiments into dying patients \u2014 two hearts and two kidneys. Revivicor provided both hearts and one of the kidneys. While the four patients died within a few months, they offered valuable lessons for researchers ready to try again in people who aren\u2019t quite as sick.<\/p>\n Now the FDA is evaluating promising results from experiments in donated human bodies and awaiting results of additional studies of pig organs in baboons before deciding next steps.<\/p>\n They\u2019re semi-custom organs \u2014 \u201cwe\u2019re growing these pigs to the size of the recipient,\u201d Ayares noted \u2014 that won\u2019t show the wear-and-tear of aging or chronic disease like most organs donated by people.<\/p>\n Transplant surgeons who\u2019ve retrieved organs on Revivicor\u2019s farm \u201cgo, \u2018Oh my god that\u2019s the most beautiful kidney I\u2019ve ever seen,\u2019\u201d Ayares added. \u201cSame thing when they get the heart, a pink healthy happy heart from a young animal.\u201d<\/p>\n The main challenges: how to avoid rejection and whether the animals might carry some unknown\u00a0infection risk.<\/a><\/p>\n The process starts with modifying genes in pig skin cells in a lab. Revivicor initially deleted a gene that produces a sugar named\u00a0alpha-gal<\/a>, which triggers immediate destruction from the human immune system. Next came three-gene \u201cknockouts,\u201d to remove other immune-triggering red flags. Now the company is focusing on 10 gene edits \u2014 deleted pig genes and added human ones that together lessen risk of rejection and blood clots plus limit organ size.<\/p>\n They clone pigs with those alterations, similar to how Dolly the sheep was created.<\/p>\n Twice a week, slaughterhouses ship Revivicor hundreds of eggs retrieved from sow ovaries. Working in the dark with the light-sensitive eggs, scientists peer through a microscope while suctioning out the maternal DNA. Then they slip in the genetic modifications.<\/p>\n \u201cTuck it in nice and smooth,\u201d murmurs senior researcher Lori Sorrells, pushing to just the right spot without rupturing the egg. Mild electric shocks fuse in the new DNA and activate embryo growth.<\/p>\n\nCreating pigs to ease the shortage of human organs<\/h4>\n