Transplanting the pig kidney for a compassionate use using a gene-edited pig as a source of xenotransplants
The transplant of the pig kidney was made possible by the Food and Drug Administration as part of a “compassionate use” program aimed at helping desperate patients.
Luhan Yang, chief executive of Qihan Biotech in Hangzhou, China, which is developing gene-edited pigs as a source for organs, says she expects more xenotransplants in clinically dead people or — for compassionate reasons — in terminally ill people in the United States, China and Europe in the coming years.
Dou says the pig was bred in a specialized pathogen-free facility and tested negative for about a dozen pathogens, including Streptococcus suis, the type-2 strain of Mycoplasma pneumoniae and porcine cytomegalovirus. The only signs of organ rejection he has seen so far are the amount of bile produced by theliver and the lack of signs of immediate rejection. Cooper says that this is encouraging.
The researchers will assess immune response, injury risk, and liver function after taking daily blood samples, biopsies, and other tests. “We’re having a pathologist evaluate if there’s acute rejection,” says Dou.
A surgery was approved by the recipient’s family and several committees. The procedures have been followed according to relevant national and international regulations.
The researchers plan to repeat the procedure in another clinically dead person later this year — and next time they will remove the person’s existing liver.
Mohiuddin points out that although clinically dead people are a useful model for assessing the viability of xenotransplantation in living people, that usefulness is limited, because once a person’s brain ceases activity, they undergo hormonal changes. And it isn’t yet clear how long someone with no cognitive function can be maintained on a ventilator and with a donated pig organ, he says. The longest documented case was two months, which involved a pig-kidney transplant.
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Yang says she hopes the team will publish detailed insights about the transplantation in peer-reviewed publications, to help determine which approach is more feasible.
Slayman got a human kidney transplant after being on dialysis for seven years, according to the hospital. But his transplanted kidney showed signs of failure after about five years, forcing Slayman to resume dialysis last May. He’s since been suffering serious complications.
“I saw it not only as a way to help me, but a way to provide hope for the thousands of people who need a transplant to survive,” Slayman said in a statement released by the hospital.
“The transplant presents a potentially significant breakthrough in the fight against the problem of ethnic minority patients not having the same access to the transplant as white patients due to the extreme donor organ shortage and other systems-based barriers,” said Winfred Williams, the kidneys specialist.
The genetic modification of pigs’ genes is a priority for several companies who are racing to produce a supply of cloned pigs that are resistant to diseases and can’t be rejected by humans. NPR recently got exclusive access to a research farm breeding these animals for a company in this competition, Revivicor Inc. of Blacksburg, Va.
The CEO of eGenesis said that they are grateful for the courage of the patient and the advancement of transplantation science. This represents a new frontier in medicine with the potential of genome engineering changing the live of millions of patients.
The field is excited about the possible use of cloning and gene-editing technologies to resolve the chronic shortage of organs for human transplantation. More than 103,000 people are currently on the waiting list for organs. 17 people die each day because they can’t get one.
But the research is also raising several concerns. It is a worry that the animals will spread the diseases to humans. Another is about slaughtering thousands of animals every year to harvest their organs. Some also question testing these organs on gravely ill patients.
L. Slay M. Johnson, a bioethicist at the State Universities of New York in Syracuse, thinks that we need to be very careful. “I have a lot of concerns about a therapy that is very much unproven.”
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The surgery took four hours on March 16 at Massachusetts General Hospital. The patient had a new organ placed in his body shortly after which it started producing urine. One of the surgeons involved said that the room erupted in applause. He said in a press conference on Thursday that it was the most beautiful he had ever seen.