NOver the last month, ew York researchers implanted pig hearts in two brain-dead individuals. It is one of many developments in the long pursuit to save human lives using animal organs.
The experiments announced Tuesday come after a historic but failed attempt earlier this year to use a pig’s heart to save a dying Maryland man — sort of a rehearsal before scientists try again in the living.
One of the most important lessons is to practice with the dead.
“We learned so much from the first one that the second one is much better,” said Dr. Nader Moazami, who led the operations at NYU Langone Health. “You stand there in awe” when the pig heart starts to beat in a human body.
This time around, Moazami’s team mimicked how heart transplants routinely are done. Researchers visited a facility that houses genetically engineered pigs twice last week and removed their hearts. They then put the pigs on ice, and flew them back hundreds of miles to New York.
They used special new methods to check for any worrisome animal viruses before sewing the heart into the chest of each deceased recipient — a Vietnam veteran from Pennsylvania with a long history of heart disease and a New York woman who’d benefited from a transplant earlier in life.
Learn More Transplants’ Future Could be in Pig Organs
Then came three days of more intense testing than living patients could tolerate — including frequent biopsies of the organ — before doctors disconnected life support.
The Food and Drug Administration has already begun to consider whether it will allow Americans with a need for a transplant to be allowed to participate in rigorous research of pig kidneys or hearts. NYU Langone is among three transplant centers planning trials — and has a meeting planned with the FDA in August to discuss requirements.
Testing in the deceased could help fine-tune how the first trials in the living are designed, said Dr. David Klassen of the United Network for Organ Sharing, which oversees the nation’s transplant system.
“They serve as an important sort of stepping stone,” said Klassen, who wonders if researchers next might consider tracking the organs for a week or so in a donated body rather than just three days.
Animal-to-human transplants, what scientists call xenotransplantation, have been tried for decades without success, as people’s immune systems almost instantly attacked the foreign tissue. Now, pigs are being genetically modified so their organs are more human-like — increasing hope that they might one day help fill a shortage of donated organs. Over 100,000 people wait on the national list to receive a transplant. Most of these are patients with kidney disease. Every year, thousands more die.
One of the most difficult attempts so far was January’s transplant of a porc heart by doctors at University of Maryland to a 57 year-old. David Bennett lived for two months and was able to survive, proving that xenotransplantation is at most possible. Initial testing revealed that the organ was infected with an animal virus. What caused Bennett’s new heart to fail and whether that virus played any role still isn’t known, the Maryland researchers recently reported in the New England Journal of Medicine.
Months earlier, the NYU team and researchers at the University of Alabama at Birmingham separately were testing pig kidney transplants in the deceased, people who’d donated their bodies for science.
NYU’s recent heart experiments will add to the evidence as the FDA decides whether to allow formal studies in living patients.
But NYU Langone’s Dr. Robert Montgomery, a kidney transplant surgeon who received his own heart transplant, said continuing careful experiments in the deceased is critical to figuring out the best methods “in a setting where a person’s life isn’t at stake.”
“This is not a one-and-done situation. This is going to be years of learning what’s important and what’s not important for this to work,” said Montgomery, who has a list of almost 50 people who’ve called desperate to volunteer for a pig kidney transplant.
The FDA hasn’t signaled how soon it might decide whether to allow such studies. At a recent two-day public meeting, the agency’s scientific advisers said it was time to try despite a long list of questions. They include how best to modify the pigs, as several biotech companies — including Revivicor, which supplied the NYU organs — are pursuing different options.
It’s not even clear which organ to attempt first in a clinical trial. A patient who has a failing kidney in a pig can still survive with dialysis. Yet some of the FDA’s advisers said starting with the heart might be better. Studies with deceased pig kidneys showed that the organs produce urine. But still unknown is whether pig kidneys do another important job — processing medications — the same way human kidneys do.
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