Organ Transplants in Virginia

there is a strong demand for organs to be transplanted
there is a strong demand for organs to be transplanted
Source: Health Resources and Services Administration, Organ Procurement and Transplantation Network Modernization Initiative

Revivicor, a subsidiary located in Blacksburg of United Therapeutics, is raising genetically engineered pigs for xenotransplantation into human patients. The pig hearts and kidneys will replace diseased and damaged human hearts and kidneys. The company built a $100 million organ production facility in Christiansburg where it could raise 200 pigs, anticipating Federal approval of xenotranspantation procedures. Another facility at Research Triangle Park in North Carolina was closer to medical facilities that conduct transplants on a routine basis, using organs from human donors.

Starting in 2024, Revicor planned to produce 125 organs per year. There was room for growth, assuming research and then clinical trials succeeded, with a company goal of 3,000 per year. Of the 100,000 people on a transplant list in the United States, 90,000 needed kidneys and about 3,300 needed hearts. Of those waiting for a transplant, 17 died each day.1

In 2022, a human who did not qualify for a traditional heart transplant heart had his removed and replaced with a pig's heart. The first patient lived for 47 days, but then died of heart failure. The patient was severely immunocompromised, and that limited the drugs which could be used to prevent rejection of the foreign tissue.

The heart had porcine cytomegalovirus (PCMV), which was latet at the time of the transplant and was not detected in testing. Since that xperiment, more sensitive assays have been developed to detect viruse before selecting a donor pig organ.2

A pig's heart provided by Revivicor was transplanted into a second human in September, 2023. Three pig genes had been removed and six human genes had been inserted into the pig genome, in order to minimize rejection by human tissue.

The xenotransplantation patient was too ill to qualify for any other transplant program. Under the Food and Drug Administration's "compassionate use" policy, experimental procedures are authorized for patients with a life-threatening condition.

Before the surgery the patient said:3

At least now I have hope and I have a chance... I will fight tooth and nail for every breath I can take.

kidneys from genetically-engineered pigs could be transplanted into humans
kidneys from genetically-engineered pigs could be transplanted into humans
Source: University of Alabama at Birmingham, Pig-to-human kidney transplant 3D animation

In Carroll and Grayson counties, farmers are considering raising specific pathogen-free (SPF) sheep for biomedical research. They are raised to be free from 54 common livestock illnesses, so each sheep is worth over $3,000 compared to $200 for mutton.

At a 2023 conference organized by the non-profit Blue Ridge Plateau Initiative, speakers proposed that specific pathogen-free sheep could become the source for organs transplanted into humans in 5-10 years. It was already possible to remove sheep tissue from organs in order to create "ghost organs" on which human cells can grow. Cells from a patient in need of a kidney could be grown on a ghost organ within a specific pathogen-free sheep. Because the cells in the replacement organ came from the patient, there would be no problems with rejection when transplanted into the patient.

The concept was visionary in 2023, and no one had committed the $15 million to $20 million in capital that would be required to go into production. Bio-secure buildings would need to be constructed inside which humans would wear biohazard suits around the sheep. Fencing would be needed to ensure the pastures were also bio-secure facilities, excluding other animals that might carry infectious organisms.

Virginia Agriculture Secretary Joseph Guthrie said optimistically:4

Southwest Virginia is a natural place for this innovative venture with our excellent grazing for sheep, a College of Veterinary Medicine nearby at Virginia Tech, and the close proximity of great medical research at places like Wake Forest University and the University of Virginia

The pigs used by Revicor are genetically modified to remove the gene that triggers alpha-gal syndrome (AGS). That syndrome is manfested after being biten by a lone star tick (Amblyomma americanum). Consuming red meat triggers an allergic reaction to Alpha-gal (galactose-α-1,3-galactose), a sugar molecule found in most mammals.

GalSafe pigs, safe for human consumption and essential for transplanting pig organs, were developed using animals at a Revivicor facility in northern Roanoke County. Revicor provides samples to people who have alpha-gel symdrome, but o date no company has foiund it economical to raise GalSafe pigs for meat. A United Therapeutics spokesperson said:5

We haven't gotten into food production because obviously we're a pharma company, not a Smithfield Foods by any means... We may make more meat available in the distant future, but our team wants to keep their heads down and focused on getting xeno organs into clinical trials.

United Therapeutics, which owned Revivicor, announced in 2023 that it planned to construct an organ production facility in Silver Spring, Maryland. That location was in the I-270 biotechnology corridor near the National Institutes of Health, the primary agency of the United States government responsible for biomedical and public health research.6

Links

References

1. "Revivicor's $100 million pig-organ facility moves forward," Virginia Business, August 30, 2023, https://www.virginiabusiness.com/article/revivicors-100-million-pig-organ-facility-moves-forward/; "Southwest Virginia scientists are gene-editing pigs for human transplants," Cardinal News, December 19, 2023, ,a href="https://cardinalnews.org/2023/12/19/southwest-virginia-scientists-are-gene-editing-pigs-for-human-transplants/">https://cardinalnews.org/2023/12/19/southwest-virginia-scientists-are-gene-editing-pigs-for-human-transplants/ (last checked December 19, 2023)
2. "Lessons Learned from First Genetically-Modified Pig Heart into Human Patient," Genetic Engineering and Biotechnology News, June 30, 2023, https://www.genengnews.com/topics/translational-medicine/lessons-learned-from-first-genetically-modified-pig-heart-into-human-patient/; "Southwest Virginia scientists are gene-editing pigs for human transplants," Cardinal News, December 19, 2023, ,a hrf="https://cardinalnews.org/2023/12/19/southwest-virginia-scientists-are-gene-editing-pigs-for-human-transplants/">https://cardinalnews.org/2023/12/19/southwest-virginia-scientists-are-gene-editing-pigs-for-human-transplants/ (last checked December 19, 2023)
3. "Genetically Modified Pig's Heart Is Transplanted Into a Second Patient," New York Times, September 22, 2023, https://www.nytimes.com/2023/09/22/health/pig-heart-transplant-faucette.html (last checked September 26, 2023)
4. "Casey: Could high-tech sheep transform Southwest Va agriculture?," The Roanoke Times, September 24, 2023, https://roanoke.com/news/state-regional/business/new-england-ovis-sheep-julie-hurley-richard-hurley-galax-virginia-blue-ridge-plateau-initiative/article_056d2390-5990-11ee-8e91-ff1a9fed9e47.html (last checked September 27, 2023)
5. "Alpha-gal Syndrome," Centers for Disease Control and Prevention, https://www.cdc.gov/ticks/alpha-gal/index.html; "Southwest Virginia scientists are gene-editing pigs for human transplants," Cardinal News, December 19, 2023, ,a hrf="https://cardinalnews.org/2023/12/19/southwest-virginia-scientists-are-gene-editing-pigs-for-human-transplants/">https://cardinalnews.org/2023/12/19/southwest-virginia-scientists-are-gene-editing-pigs-for-human-transplants/ (last checked December 19, 2023)
56. "United Therapeutics eyes big organ production facility in Silver Spring," Washington Business Journal, December 15, 2023, https://www.bizjournals.com/washington/news/2023/12/15/silver-spring-united-therapeutics-expansion.html; "Geting to NIH," National Institutes of Health, https://www.nih.gov/about-nih/visitor-information/getting-nih (last checked December 15, 2023)


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