CNN
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One month after an experimental procedure to transplant a genetically modified pig heart into a patient with end-stage heart disease, doctors said the heart was functioning naturally and showed no signs of rejection.
In September, 58-year-old Lawrence Fawcett underwent surgery, only the second time ever for a human. Mr. Fawcett’s heart disease and pre-existing health conditions prevented him from undergoing a traditional human heart transplant.
“The doctors treating him believe that his heart function is good,” the doctor said. bartley griffithdirector of the heart and lung transplant program at the University of Maryland School of Medicine, who performed the surgery.
“At this time, there is no evidence of infection or evidence of rejection.”
Dr. Muhammad Mohiuddin“We will be discontinuing all medications that were initially supporting his heart,” the head of UMMC’s cardiac xenotransplant program said in an update shared Friday. So now his mind is doing everything on its own. ”
Mohiuddin said the focus now is on ensuring Fawcett is strong enough to perform day-to-day functions.
“We are working hard with the physical therapy team. They are spending a lot of time helping him regain the strength he lost during the past month of hospitalization,” Mohiuddin said.
A video released by UMMC shows Fawcett undergoing physical therapy, including cycling, to strengthen his leg strength. When physiotherapist Chris Wells reminds her to keep smiling, Fawcett laughs and says: “That’s the difficult part!”
When Fawcett came along, “I honestly never thought I’d ever be able to stand up again,” Griffith said. Fawcett is not yet independent, but doctors say he is at a “critical point” as he is able to get out of bed with minimal assistance.
Mr Griffiths said it was now time to plan the next stage of Mr Fawcett’s recovery and “think about where Larry will go next”.
Fawcett is a married father of two from Frederick, Maryland, and a 20-year Navy veteran who most recently worked as a laboratory technician at the National Institutes of Health.
In another moment shared by UMMC, Fawcett is seen undergoing a heart scan with doctors. “This looks like a completely normal heart, and that’s definitely what we wanted,” he says.
Fawcett was first admitted to UMMC on Sept. 14 after experiencing symptoms of heart failure. During his hospital stay, his heart stopped twice and he was only able to be revived because there was an automatic defibrillator in his room.
“The only real hope I have left is to choose a pig heart, a xenotransplant,” Dr. Fawcett said in an internal interview at the hospital a few days before the surgery.
His wife, Anne Fawcett, said at the time: “I have no expectations other than hoping we can spend more time together.” “It could be as simple as sitting on your front porch and having coffee together.”
The experimental xenotransplant procedure was given the green light under the U.S. Food and Drug Administration’s “compassionate use” program.by F.D.A.the program is “a potential pathway for patients with serious or immediately life-threatening diseases or conditions to receive treatment.” Investigational new drug For treatment outside of clinical trials (drugs, biologics, or medical devices) when there are no equivalent or satisfactory alternative treatment options. ”
The pig hearts used were from genetically modified pigs. libiv call, A subsidiary of United Therapeutics Corporation. The pig had 10 genes edited, three of which were “knocked out” or inactivated, allowing the pig to trigger a severe reaction in the human immune system and potentially lead to organ rejection. α-gal sugar in blood cells was removed. Additional pig genes were modified to control pig heart growth, while six human genes were added to the pig genome to increase its acceptability by the immune system.of F.D.A. In 2020, the first gene-edited pigs were approved for therapeutic use and consumption.
Currently, there are no clinical trials using pig organs for transplantation into living humans.
Doctors also treated Fawcett with an experimental antibody treatment to further suppress his immune system and prevent rejection. They continue to be monitored for signs of rejection or the development of pig-related viruses. Donor pigs were rigorously tested for any signs of viruses or pathogens.
The hospital said Fawcett fully consented to the experimental treatment and was informed of all risks. Additionally, he underwent a full psychiatric evaluation and discussed his case with a medical ethicist.
Mohiuddin and Griffiths founded the country’s first cardiac xenotransplant research center, and performed the first experimental surgery on 57-year-old David Bennett in January 2022. Mr. Bennett died two months after the surgery.
Although there were no signs of rejection in the first few weeks after the transplant, an autopsy ultimately concluded that Bennett died of heart failure. “Complex array of elements” Including Bennett’s condition before surgery. Bennett had already been in the hospital for six weeks before the transplant and was kept on a heart-lung bypass machine. However, case studies by doctors lancet It also pointed out that there was evidence of a previously unidentified swine virus.
According to the federal government, more than 113,000 people live in the area. organ transplant list, including more than 3,300 people in need of a heart.group Donate to Life America According to , 17 people die every day while waiting for organ donation.
