Advances are increasing the supply of organs. But this isn’t enough. Enter the genetically modified donor pig
Robert Montgomery walked deliberately down the hospital hallway carrying a stainless-steel bowl containing a living human kidney resting on a bed of ice. Minutes earlier the organ had been in one man's body. It was about to be implanted into another man to keep him alive.
Recent medical advances in treating infections such as hepatitis C and HIV have made previously unusable organs usable. In addition, technology has made it possible to keep organs viable for longer outside a body before a transplant and even to improve their quality. Yet the demand for organs still far outstrips the supply.
I can relate to the anxiety of waiting for an organ that may never come. My mother was diagnosed in 2019 with pulmonary fibrosis, a progressive and deadly lung-scarring illness with a two- to five-year prognosis, on average, after diagnosis. The disease has no cure, but a lung transplant offered the possibility of extending her life.
One development has been driving an increase in donor organs, but it's nothing to celebrate. It's the opioid epidemic. People who die of drug overdoses now constitute a significant fraction of donors—rising from 1 percent of donors in 2000 to more than 13 percent in 2017—and it doesn't seem like the crisis will abate anytime soon. “Our success right now is based on a failure in our society,” Montgomery says.
Rothblatt and United Therapeutics are pursuing several approaches to achieve this goal. The company is investing in systems that can keep lungs alive outside the body until they are ready to be transplanted. The machines pump oxygen and nutrients through the lungs and keep them warm—a process called ex vivo lung perfusion. Similar systems have been used for years for kidneys and in some cases livers.
There were a few more xenotransplants in the 1990s, but it became clear that better immunosuppression alone would not solve the problem. So scientists began modifying genes that triggered immune reactions. In 2000 PPL Therapeutics created the first cloned pigs and began genetically engineering them as a source of organs for human transplants. In 2011 United Therapeutics acquired Revivicor.
In 2021 Montgomery and his colleagues at NYU Langone and transplant surgeon Jayme Locke and her colleagues at the University of Alabama at Birmingham separately transplanted pig kidneys into people who had suffered brain death—known as decedents—with the families' consent. These experiments were done to show that pig organs could function in a human body without causing harm.
I watched the transplant via a video feed from the hospital's “control room,” which was packed with doctors and researchers labeling vials that would later contain urine, blood and tissue from both the kidney and the decedent for subsequent analysis. Although experiments like these provide useful data, proving that such transplants are safe and effective will require clinical trials in live patients. The FDA has signaled that it is open to starting phase I clinical trials of xenotransplants once it has enough preclinical data. The teams at the University of Maryland, NYU Langone and the University of Alabama hope to be among the first the perform them.
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