Surgeons in Baltimore transplanted the heart of a genetically modified pig into a man. The patient had terminal heart disease and there was no other hope for treatment, according to the University of Maryland Medical Center this Friday (22).
This is the second procedure of this type performed by the surgeons. The first patient, David Bennett, 57, died two months after the transplant, but the pig heart functioned well and there were no signs of acute rejection of the organ, an important risk in these procedures.
The second patient, Lawrence Faucette, 58, a Navy veteran and father of two from Frederick, Maryland, underwent transplant surgery on Wednesday and is “recovering well and communicating with his loved ones,” the medical center said. in a statement.
Faucette, who had terminal heart disease and other complicating medical conditions, was so ill that he had been rejected from all transplant programs that use human donor organs.
“At least now I have hope and I have a chance,” Faucette said before the surgery. “I will fight tooth and nail for every breath I can take.”
The transplant was performed by Bartley Griffith, who operated on the first patient. Muhammad Mohiuddin of the University of Maryland School of Medicine designed the protocol.
Bennett, the first patient, died after multiple complications. Traces of a virus that infects pigs were found in his new heart, raising concerns that so-called xenotransplants — that is, organ transplants between species, in this case, from animals to people — could introduce new viruses into the human population.
Hospital officials said they repeatedly tested the pig used in the transplant last week for both the virus, called porcine cytomegalovirus, and for antibodies using a new assay that was not available at the time of Bennett’s transplant.
Before undergoing the transplant, Faucette said he recognized it would be a miracle if he made it out of the hospital and go home, and another miracle if he lived for months or another year.
“Realistically, this is in the early stages of learning,” he said of the procedure.
In recent years, the science of xenotransplantation has made great strides with gene editing and cloning technologies designed to make animal organs less likely to be rejected by the human immune system.
Although the advances are still in the early stages, they offer hope for, in the case of the United States, where the procedure was performed, the more than 100,000 Americans who live with terminal organ-related illnesses but face an acute shortage of donors. Most people waiting for an organ need a kidney, but fewer than 25,000 kidney transplants are performed each year and thousands die on waiting lists.
Transplant surgeons at the University of Alabama at Birmingham and NYU Langone Health have transplanted kidneys from genetically engineered pigs into brain-dead patients kept on ventilators, demonstrating that the kidneys can produce urine and perform other essential biological functions without being rejected.
“There is a growing need for organs and for people with end-stage organ failure who are out of options,” said Jay Fishman, professor of medicine at Harvard and associate director of the Transplant Center at Massachusetts General Hospital.
“While cadaver trials are informative, transplants in living recipients are, of course, more relevant to advancing knowledge in the field,” Fishman added. He said he was optimistic that the surgery would encourage scientists to enter the field and speed the path to clinical trials.
The heart transplanted to Faucette came from a pig that had received ten genetic modifications. Scientists removed three pig genes that cause rapid rejection of pig organs by the human immune system, while inserting six human genes that allow our immune system to accept the organ.
An additional pig gene, responsible for the growth of the heart, was disabled to prevent the organ from becoming too large.
The genetically altered pig was provided by Revivicor, a Blacksburg, Virginia-based regenerative medicine company that is a subsidiary of United Therapeutics Corp. Before transplantation, the pig was tested for viruses, bacteria and parasites.
The FDA (Food and Drug Administration, the American agency that regulates foods and drugs, like the Brazilian Anvisa) granted emergency approval for the transplant last week under a “compassionate use” process that allows experimental procedures to be carried out in a single patient with a life-threatening condition.
Faucette is also receiving a new experimental antibody therapy developed by Eledon Pharmaceuticals called tegoprubart, which blocks a protein involved in activating the immune system. Other conventional medications are also being used to suppress your immune system and prevent organ rejection.
Faucette’s wife, Ann, said the two were keeping expectations low and just hoping for more time together. “This can be as simple as sitting on the front porch and having coffee together,” she said.