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Virus World provides a daily blog of the latest news in the Virology field and the COVID-19 pandemic. News on new antiviral drugs, vaccines, diagnostic tests, viral outbreaks, novel viruses and milestone discoveries are curated by expert virologists. Highlighted news include trending and most cited scientific articles in these fields with links to the original publications. Stay up-to-date with the most exciting discoveries in the virus world and the last therapies for COVID-19 without spending hours browsing news and scientific publications. Additional comments by experts on the topics are available in Linkedin (https://www.linkedin.com/in/juanlama/detail/recent-activity/)
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Signs of an Animal Virus Discovered in Man Who Received a Pig’s Heart - The New York Times

Signs of an Animal Virus Discovered in Man Who Received a Pig’s Heart - The New York Times | Virus World | Scoop.it

The patient showed no sign of rejecting the genetically modified organ, but suffered numerous complications before dying. Traces of a virus known to infect pigs were found in a 57-year-old Maryland man who survived for two months with a heart transplanted from a genetically altered pig, according to the surgeon who performed the procedure, the first of its kind. The disclosure highlights one of the most pressing objections to animal-to-human transplants, which is that widespread use of modified animal organs might facilitate the introduction of new pathogens into the human population. The presence of the virus’s DNA in the patient may have contributed to his sudden deterioration more than a month after the transplant, said the surgeon, Dr. Bartley Griffith of the University of Maryland School of Medicine. But there was no evidence that the patient developed an active infection with the virus, or that his body had rejected the heart, Dr. Griffith added.  The patient, David Bennett Sr., had been extremely ill before the surgery and suffered numerous other complications after the transplant. He died on March 8. Dr. Griffith’s revelations about the viral traces found in the patient, made last month during an American Society of Transplantation meeting, were first reported by MIT Technology Review.

 

In an interview with The New York Times on Thursday, Dr. Griffith and his colleague, Dr. Muhammad Mohiuddin, the scientific director of the cardiac xenotransplantation program at University of Maryland School of Medical, said that they were saddened by the loss of Mr. Bennett but that they were not deterred from their goal of using animal organs to save human lives.  “This doesn’t really scare us about the future of the field, unless for some reason this one incident is interpreted as a complete failure,” Dr. Griffith said. “It is just a learning point. Knowing it was there, we’ll probably be able to avoid it in future.” The pig, which had been genetically modified so that its organs would not trigger rejection by the human immune system, was provided by Revivicor, a regenerative medicine company based in Blacksburg, Va.  Company officials declined to comment on Thursday, and officials with the Food and Drug Administration, which gave the transplant surgeons emergency authorization for the operation on New Year’s Eve, said they could not immediately respond to questions. University officials said that although the pig had been screened several times for the virus, the tests pick up only active infections, not latent ones in which the virus may hide quietly in the pig’s body. (The tests were done on nasal swabs, but the virus was later detected in the pig’s spleen.) The latent virus might have “hitched a ride” into the patient on the transplanted heart, Dr. Griffith said. Mr. Bennett’s transplant was initially deemed successful. He did not show signs of rejecting the organ, and the pig’s heart continued to function for well over a month, passing a critical milestone for transplant patients. A test first indicated the presence of porcine cytomegalovirus DNA in Mr. Bennett 20 days after the transplant, but at such a low level that Dr. Griffith said he thought it might have been a lab error. About 40 days after the surgery, however, Mr. Bennett suddenly became acutely ill, and subsequent tests showed a precipitous rise in viral DNA levels, Dr. Griffith said.

 

“So we started thinking that the virus that showed up very early at Day 20 as just a twinkle started to grow in time, and it may have been the actor — it could have been the actor — that set this all off,” Dr. Griffith told other transplant scientists at the meeting. At Day 45, Mr. Bennett’s health abruptly deteriorated. Doctors treated Mr. Bennett with antiviral drugs and intravenous immune globulin (IVIG), a product made of antibodies, but the new heart filled with fluid, doubled in size and stopped working, and he was eventually put on a heart-lung machine. The heart transplant was one of several groundbreaking transplants in recent months that offer hope to the tens of thousands of patients who need new kidneys, hearts and lungs amid a dire shortage of donated human organs. Surgeons in New York in October successfully attached a kidney grown in a genetically altered pig to a brain-dead patient, and found that the organ worked normally and produced urine. In January, surgeons at the University of Alabama at Birmingham reported that they had transplanted kidneys from a genetically modified pig into the abdomen of a 57-year-old brain-dead man. But the prospect of unforeseen consequences — and particularly the potential introduction of animal pathogens into the human population — may dampen enthusiasm for the use of genetically modified organs. The coronavirus that set off the global Covid pandemic is believed by many scientists to have originated with a virus that was transmitted from an unidentified animal to people in China. 

 

Porcine cytomegalovirus has not been a major concern, since it is a herpesvirus, which tend to be species-specific, said Dr. Jay Fishman, associate director of the transplantation center at Massachusetts General Hospital, who studies infectious diseases. “They will replicate only in the host with which they are associated,” Dr. Fishman said. Nevertheless, the virus could infect the transplanted animal organ, leading to a cascade of systemic effects that ultimately harm the patient. “Did this contribute to the patient’s demise? The answer is obviously, we don’t know, but it might have contributed to his overall not doing well,” Dr. Fishman said. Dr. Jayme Locke, a transplant surgeon who is director of the Incompatible Kidney Transplant Program at University of Alabama at Birmingham, said genetically modified pigs whose organs are to be used for transplantation must be raised in a pathogen-free facility and weaned from their mothers within 48 hours of birth, in order to prevent transmission of porcine cytomegalovirus during lactation. The university has such a facility, and Dr. Locke said she was still planning to start a small Phase 1 clinical trial in which she will transplant kidneys from genetically modified pigs into people with end-stage kidney disease. More sensitive screening of the animals for the virus will be required, she added.“ From my perspective, it’s not slowing down what we need to do, but further emphasizing that data showing our herd is free of that virus will be critical” for regulatory permission to move forward, she said.

 
 
Romain Bagard's curator insight, December 9, 2023 6:13 AM

Malheureusement toutes les découvertes ne se font pas toujours pour le bien des patients...

acheter-victoza-en-ligne's curator insight, December 29, 2023 6:22 AM

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good health's curator insight, January 10, 6:52 AM

Acquista Online La Prescrizione Di Perdita Di Peso
Crediamo che i farmaci a volte possano essere molto urgenti da assumere. Se hai urgente bisogno di farmaci, possiamo anche fornirti una consegna espressa,


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Here’s How Scientists Pulled Off the First Pig-to-Human Heart Transplant | Science | AAAS

Here’s How Scientists Pulled Off the First Pig-to-Human Heart Transplant | Science | AAAS | Virus World | Scoop.it

Surgeons announced this week they had performed the first transplant of a pig heart to a human. The 7 January surgery was a milestone for research on transplants between species, known as xenotransplantation. It’s still unclear how well or how long the heart will function, but researchers hope the technique can someday make up for a shortage in human organs for ailing patients. The procedure, done by a team at the University of Maryland School of Medicine (UMSOM), was a major test for several experimental innovations designed to keep the pig heart functioning in a human chest, including 10 genetic changes in the pigs, a novel immunosuppressant given to the recipient, and a cocaine-laced solution used to incubate the heart. Here’s how science and ethical considerations informed the complex procedure.

Why did this patient get a pig heart?

The transplant recipient, 57-year-old David Bennett, had advanced heart failure and a type of arrhythmia called ventricular fibrillation. Because he had not taken steps to control his high blood pressure and other health problems, physicians at the University of Maryland Medical Center and nearby institutions deemed him ineligible for a human heart transplant, says Muhammad Mohiuddin, director of the cardiac xenotransplantation program at UMSOM. “A human organ is considered a very precious thing,” he says. “The main concern was whether to give the heart to a person who may not be able to take care of it.” Instead, with Bennett’s consent, the UMSOM team sought a “compassionate use” authorization from the U.S. Food and Drug Administration (FDA) to give him a heart from a genetically modified pig created by Revivicor, a biotech company. Mohiuddin and colleagues have worked with pig organs provided by Revivicor for years. In 2016, they reported that pig hearts could remain healthy for more than 2 years when transplanted into a baboon's abdomen, and have since done transplants into baboons’ chests, where the hearts sustain life. In recent experiments, baboons relying on Revivicor’s pig hearts survived up to 9 months, Mohiuddin says. (Those primates died with functioning hearts after contracting lung infections unrelated to the transplant, he says.)

What genes were changed in the donor pig, and why?

Xenotransplantation risks provoking rejection, an immune response in the recipient that can cause the organ from another species to fail. A key problem is that antibodies produced by people recognize certain sugars on the surface of pig cells as foreign. “You really need to get rid of as much antibody binding as you can upfront to get the graft to survive longer,” says Joseph Tector, a transplant surgeon at the University of Miami who was not involved with the new surgery. So, in one of its lines of engineered pigs, Revivicor knocked out three genes for enzymes that enable pig cells to synthesize those sugars.  Six tweaks were additions of human genes: two anti-inflammatory genes, two genes that promote normal blood coagulation and prevent blood vessel damage, and two other regulatory proteins that help tamp down antibody response. A final modification removed the gene for a growth hormone receptor to reduce the chance that a pig organ, roughly matched in size to the patient’s chest, will outgrow it once implanted. In September 2021, Mohiuddin and colleagues reported that this modification reduced the growth of pig hearts transplanted into baboons—a change they expect will help prevent heart failure in people.

Were all 10 genetic changes necessary?

That’s not clear, xenotransplantation researchers say. In collaboration with Revivicor, the UMSOM team has studied baboons with progressively more genetic modifications and seen increasing longevity in the hearts. But baboon experiments are costly, and limits on the number of animals in a study make it difficult to test the effects of each modification independently. “We don’t know how much each of those genes is helping,” Mohiuddin says. That uncertainty is “one of my reservations about this,” says Megan Sykes, a transplant immunologist at Columbia University. “We really do need to do more science … to determine which [modifications] are important and useful.” Certain changes can prove helpful in some types of transplants and harmful in others: Inserting the human anti-inflammatory gene CD47 improved outcomes of bone marrow transplants from pigs to baboons, but pig kidneys with that modification in all of their cells seem prone to inflammation and swelling, she says. As xenotransplantation scales up to treat more people, the need for consistency might also limit the number of added human genes, Tector notes. He founded the biotech company Makana Therapeutics, acquired by Recombinetics Inc., which is preparing to launch a clinical trial of genetically engineered pig-to-human kidney transplants this year. “The level of expression from animal to animal, even when they’re clones, can be quite different,” Tector says. “If you’re a regulator … you want to say, ‘OK, this kidney is the same as that kidney.’”

Is the patient’s immune system being suppressed?

Even with the modifications to the heart, to prevent rejection, the UMSOM team is giving Bennett a strong immunosuppressant: an experimental antibody drug called KPL-404, made by Kiniksa Pharmaceuticals, Ltd. Standard immunosuppressants used in human-to-human organ transplants aren’t effective if the immune system makes lots of antibodies against the organ, as surgeons feared would be the case with the pig heart. KPL-404 shuts down production of these antibodies by binding to a cellular receptor called CD40, suppressing the activity of antibody-producing B cells, and inhibiting their cross-talk with T cells that coordinate the immune system’s response to an invader. “The 10 [altered] genes help, but the anti-CD40 antibody, which had been my main focus throughout my career, I think is the game changer,” Mohiuddin says. Kiniksa has been working on KPL-404 as a treatment for rheumatoid arthritis and announced positive results from a safety trial in healthy volunteers in May 2021.

How was the heart prepared for transplant?

Immune rejection aside, pig hearts transplanted into baboons seem to sputter out in a matter of days unless they’re perfused with a nutrient solution before the transplant, Mohiuddin says. The mechanisms behind the hearts’ failure are unclear, though he speculates that being deprived of blood flow and oxygen when removed from the pig chest somehow depletes the energy-producing mitochondria in the organ’s cells. The UMSOM team relied on a method developed by Lund University surgeon Stig Steen and commercialized by the Swedish company XVIVO for storing and treating the donor heart after it’s harvested. The heart is bathed in a circulating broth that includes water, hormones such as adrenaline and cortisol—and dissolved cocaine. How cocaine helps keep the bodiless heart healthy isn’t clear, Mohiuddin says, but its presence in the solution creates a headache when his team imports a new batch from Sweden; each shipment needs a permit from the U.S. Drug Enforcement Administration.

Will more patients get pig hearts now?

The authorization UMSOM received from FDA only applies to one patient. “There’s a chance that if we get another patient like this, we will apply for [another],” Mohiuddin says. But his team’s main goal is to advance the approach into a multicenter clinical trial. The team will have to do more tests showing long-term survival in baboons to get FDA approval for the trial, he says. “This is not a one-off,” says Revivicor CEO David Ayares of Bennett’s surgery. “We’re going to take this all the way through to human clinical trials, and hopefully have an unlimited supply of donor organs.” The company is constructing a new clinical-grade facility for raising its pigs to meet FDA standards for such a trial, which he expects to launch by the end of 2023.

Emma Guimont's curator insight, January 6, 5:16 AM
La première transplantation d’un cœur de porc à un humain a récemment été effectué. La recherche sur les transplantations entre espèces est connue sous le nom de xénotransplantation. On ne sait toujours pas si le cœur fonctionnera ou combien de temps, mais les chercheurs espèrent que la technique pourra un jour compenser une pénurie d’organes humains pour les patients malades.

L’équipe de l’UMSOM s’est appuyée sur une méthode développée par le chirurgien de l’Université de Lund, Stig Steen, pour stocker et traiter le cœur du donneur après sa récolte. Le cœur est baigné dans un bouillon qui contient de l’eau, des hormones comme l’adrénaline et le cortisol — et de la cocaïne dissoute.