One step away
Having successfully transplanted pig islets into monkeys, the researchers are eager to develop a safe, effective protocol for doing the same in humans.
Bernhard Hering, M.D., led a study that successfully reversed diabetes in 12 monkeys using islets transplanted from pigs. Now Hering and his research team are eager to prove that islets from pigs can safely and effectively reverse diabetes in humans as well.
"There's a lot of momentum to position us to expedite and lead the development of pig islets to potentially benefit people with diabetes," Hering says. "This is one step away for us. The question is, How long will that step be?"
Before pig islet transplantation can enter clinical trials, the researchers must conduct additional studies — based on what they've learned about how the monkeys' immune systems reacted to the pig islets — to identify an antirejection strategy for humans. They also must find a way to raise pigs under the stringent conditions required by the U.S. Food and Drug Administration for producing tissue for use in humans.
"We have both initiatives well under way," Hering says. The institute has recruited several additional researchers to carry the antirejection work forward. It is also looking at novel approaches, such as placing islets and antirejection drugs together under the skin or in abdominal fat to avoid the adverse effects of full-body immune suppression.
While researchers continue their work, a separate nonprofit organization, Spring Point Project, is working to fund and build a facility for raising the pigs needed to produce islets. The researchers hope to receive FDA approval to start the clinical trial phase in three years, with the first pig islets implanted in humans within about five years.
There's a lot of momentum to position us to expedite and lead the development of pig islets to potentially benefit people with diabetes. This is one step away for us. The question is, How long will that step be?— Bernhard Hering, M.D.
"At some point in the hopefully not-too-distant future, people with diabetes will have better options available to them," Hering says. "They will be able to get a pig islet transplant without toxic immune suppression and enjoy the beauty of life free of diabetes."
As he looks forward to further advances, Hering also expresses gratitude to the donors who made it all possible by investing in exploratory research.
"They positioned us to do the initial work to show proof of principle," he says. "If we had gone with the initial idea to major funding organizations, they would have said, ‘Now you have gone completely insane.' That's why you need philanthropic donations."