In a first-of-its-kind surgery, a 57-year-old patient with terminal heart disease received a successful transplant of a genetically-modified pig heart and is still doing well three days later.
It was the only currently available option for the patient. The historic surgery was conducted by University of Maryland School of Medicine.
This organ transplant demonstrated for the first time that a genetically-modified animal heart can function like a human heart without immediate rejection by the body.
The patient, David Bennett, is being carefully monitored over the next days and weeks to determine whether the transplant provides lifesaving benefits. He had been deemed ineligible for a conventional heart transplant at UMMC as well as at several other leading transplant centers that reviewed his medical records.
“It was either die or do this transplant. I want to live. I know it’s a shot in the dark, but it’s my last choice,” said Mr. Bennett, the patient, a day before the surgery was conducted. He had been hospitalized and bedridden for the past few months. “I look forward to getting out of bed after I recover.”
Eve through its expanded access (compassionate use) provision. It 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 authorization to proceed was granted in the hope of saving the patient’s life.
“This was a breakthrough surgery and brings us one step closer to solving the organ shortage crisis. There are simply not enough donor human hearts available to meet the long list of potential recipients,” said Bartley P. Griffith, MD, who surgically transplanted the pig heart into the patient. Dr. Griffith is the Thomas E. and Alice Marie Hales Distinguished Professor in Transplant Surgery at UMSOM. “We are proceeding cautiously, but we are also optimistic that this first-in-the-world surgery will provide an important new option for patients in the future.”
“This is the culmination of years of highly complicated research to hone this technique in animals with survival times that have reached beyond nine months. The FDA used our data and data on the experimental pig to authorize the transplant in an end-stage heart disease patient who had no other treatment options,” said Dr. Mohiuddin. “The successful procedure provided valuable information to help the medical community improve this potentially life-saving method in future patients.”
About 110,000 Americans are currently waiting for an organ transplant, and more than 6,000 patients die each year before getting one, according to the federal government’s organdonor.gov.
10 unique gene edits
Bennett’s donor pig belonged to a herd that had undergone genetic editing procedures.
Three genes that would have led to rejection of pig organs by humans were “knocked out,” as was a gene that would have led to excessive growth of pig heart tissue.
Six human genes responsible for human acceptance were inserted into the genome, for a total of 10 unique gene edits.
The editing was performed by Virginia-based biotech firm Revivicor, which also supplied the pig used in a breakthrough kidney transplant on a brain dead patient in New York in October.
But while that surgery was purely a proof-of-concept experiment, and the kidney was connected outside the patient’s body, the new surgery is intended to save a person’s life.