Earlier this month, in Baltimore City, a 58-year-old patient with terminal heart disease became the second patient in the world to receive a historic transplant of a genetically-modified pig heart. He is recovering and communicating with his loved ones.
“We are continuing to pursue the pathway to clinical trials by providing important new data on pre-clinical research that has been requested by the FDA,” said Dr. Mohiuddin. “The FDA used our data from these new studies, as well as our experience with the first patient, to determine that we were ready to attempt a second transplant in an end-stage heart disease patient who had no other treatment options.”
This is only the second time in the world that a genetically modified pig heart has been transplanted into a living patient. Both historic surgeries were performed by the University of Maryland School of Medicine (UMSOM) faculty at the University of Maryland Medical Center (UMMC). The first historic surgery, performed in January 2022, was conducted on David Bennett by UMMC surgeons, who are recognized as the leaders in cardiac xenotransplantation.
This new patient, Lawrence Faucette, had end-stage heart disease. He was deemed ineligible for a traditional transplant with a human heart by UMMC and several other leading transplant hospitals, due to his pre-existing peripheral vascular disease and complications with internal bleeding.
This transplant was the only option available for Mr. Faucette who was facing near-certain death from heart failure. The patient, who lives in Frederick, Maryland, is a married father of two and a 20-year Navy veteran and most recently worked as a lab technician at the National Institutes of Health before his retirement.
“My only real hope left is to go with the pig heart, the xenotransplant,” said Mr. Faucette during an interview from his hospital room a few days before his surgery. “Dr. Griffith, Dr. Mohiuddin and their entire staff have been incredible, but nobody knows from this point forward. At least now I have hope, and I have a chance.” His wife, Ann Faucette added: “We have no expectations other than hoping for more time together. That could be as simple as sitting on the front porch and having coffee together.”
The U.S. Food and Drug Administration granted emergency approval for the surgery on Friday, September 15 through its single patient investigational new drug (IND) “compassionate use” pathway. This approval process is used when an experimental medical product, in this case the genetically-modified pig’s heart, is the only option available for a patient faced with a serious or life-threatening medical condition. The approval was granted in the hope of saving the patient’s life.
Organs from genetically modified pigs have been the focus of much of the research in xenotransplantation, in part because of physiologic similarities between pigs and humans and nonhuman primates. Three genes—responsible for a rapid antibody-mediated rejection of pig organs by humans—were “knocked out” in the donor pig. Six human genes responsible for immune acceptance of the pig heart were inserted into the genome.
“We are once again offering a dying patient a shot at a longer life, and we are incredibly grateful to Mr. Faucette for his bravery and willingness to help advance our knowledge of this field,” said Bartley P. Griffith, MD, who surgically transplanted the pig heart into both the first and second patient at UMMC. “We are hopeful that he will get home soon to enjoy more time with his wife and the rest of his loving family.”
Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world— with 46 academic departments, centers, institutes, and programs, and a faculty of more than 3,000 physicians, scientists, and allied health professionals.