Genetically modified pig heart transplanted into second patient | ET REALITY


Baltimore surgeons transplanted the heart of a genetically altered pig into a man with terminal heart disease who had no other hope for treatment, the University of Maryland Medical Center announced Friday.

It is the second such procedure performed by the surgeons. The first patient, David Bennett, 57, died two months after his transplant, but the pig’s heart functioned well and there were no signs of acute rejection of the organ, a major risk in these types of procedures.

The second patient, Lawrence Faucette, 58, a Navy veteran and married father of two in Frederick, Maryland, underwent transplant surgery Wednesday and is “recovering well and communicating with loved ones,” the medical center said in a statement.

Mr. Faucette, who had terminal heart disease and other complicated medical conditions, was so sick that he had been rejected from all transplant programs that use organs from human donors.

“At least now I have hope and a chance,” Faucette said before surgery. “I will fight tooth and nail for every breath I can take.”

The transplant was performed by Dr. Bartley Griffith, who operated on the first patient. Dr. Muhammad Mohiuddin of the University of Maryland School of Medicine designed the protocol.

Bennett died after multiple complications and traces of a virus that infects pigs were found in his new heart, raising concerns that so-called xenotransplants of organs from animals to people could introduce new pathogens 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 antibodies using a new assay that was not available at the time of Mr. Bennett’s transplant.

Before undergoing the transplant, Faucette said he recognized that it would be a miracle if he could leave the hospital and return home, and another miracle if he lived months or a year longer.

“Realistically, this is early in the learning process,” he said of the procedure.

In recent years, xenotransplantation science has made great strides with cloning and gene editing technologies designed to make animal organs less likely to be rejected by the human immune system.

Although advances are still in nascent stages, they offer hope to the more than 100,000 Americans who live with end-stage organ diseases but face a severe shortage of human donor organs. Most of those 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 modified pigs into brain-dead patients maintained 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 people with end-stage organ failure who have no options,” said Dr. Jay Fishman, a professor of medicine at Harvard and associate director of the Transplant Center at Massachusetts General Hospital.

“While deceased trials are informative, transplants in living recipients are, of course, the most relevant to advancing knowledge in this field,” Dr. Fishman added. He said he was optimistic that the surgery would encourage scientists to enter the field and accelerate the path to clinical trials.

The heart transplanted into Mr. Faucette came from a pig that had received 10 genetic modifications. The scientists deleted three porcine genes that cause rapid rejection of porcine organs by the human immune system, while inserting six human genes that allow the immune system to accept the organ.

An additional porcine gene, responsible for heart growth, was deleted to prevent the organ from growing too much.

The genetically altered pig was provided by Revivicor, a Blacksburg, Virginia-based regenerative medicine company that is a subsidiary of United Therapeutics Corporation. Before transplantation, the pig was examined for viruses, bacteria and parasites.

The Food and Drug Administration granted emergency approval to the transplant last week under a “compassionate use” process that allows experimental procedures to be performed on a single patient who has a life-threatening condition.

Mr. 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 used to suppress his immune system and prevent rejection of the organ.

Faucette’s wife, Ann, said the two were keeping expectations low and just hoping to spend more time together. “That could be as simple as sitting on the porch and having coffee together,” she said.

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