For many people, a new year represents an opportunity for a fresh start. But for over 100,000 Americans waiting for an organ transplant, it means another year of anxiety and clinging to hope. A small portion of those patients will eventually get a transplant, though their health may deteriorate while they wait. But with each passing year, most people on the waiting list will not receive the life-saving organ they need.
This chronic organ shortage has been a long struggle for the medical profession and very little progress has occurred. In fact, given the rising cases of organ failure and resulting increase in demand, things are getting worse for patients. A new name is added to the transplant waiting list every nine minutes. The truth is there simply will never be enough human organs available to meet the need. That is why scientists have begun to think outside the box to solve the shortage.
In the past decade, scientists have been diligently working to find innovative solutions to meet the shortfall and save lives. One of the most promising solutions: Pigs. At first glance, that animal may seem an unlikely candidate. In fact, pigs are a great candidate for organ supply because they are an extremely close physiological match for humans. Pigs have long been used successfully in medicine – including for skin grafts and heart valve transplants.
Now, cutting-edge scientists and transplant surgeons are charting the course for transplanting full pig organs into people who need a healthy organ. They believe that xenotransplantation, the process of transplanting organs or tissues from one species to another, holds the key to ending the organ shortage crisis.
In addition to providing an increased supply of organs, xenotransplantation from pigs can potentially improve the organ transplant success rate for patients. Many organ transplants fail due to rejection, in which the body’s immune system attacks and destroys the transplanted organ. Xenotransplantation can potentially reduce the risk of rejection by using organs that have been genetically tailored to reduce the immune response.
For example, Dr. Joseph Tector, a transplant surgeon at the Miami Transplant Institute and a leader in the field of xenotransplantation research, has crafted a new process for gene editing that his laboratory Makana Therapeutics calls the “triple knockout.” This unique and innovative technology removes three specific antigens that trigger the rejection of new organs. Innovations like this are what drive the science of xenotransplantation forward and closer to the day when no patient has to wait four or more years for a new organ.
This innovation may sound more like the plot of a futuristic movie than modern science, but the fact is that transplant surgeons and scientists believe clinical trials could be approved by the U.S. Food and Drug Administration (FDA) as soon as this year. As it considers that approval, it must consider the massive impact this science could have in saving patients’ lives. The federal government should be in the business of nurturing potentially lifesaving innovations with strict adherence to the best science. That’s why it is vitally important that the federal government, and specifically the FDA, balance patient safety with the urgent need for breakthroughs in the organ transplant space.
The recent pig heart transplant to a Maryland man last year, which may have failed due to viral contamination, showed both the promise of xenotransplantation and the urgent need for the FDA to set one, scientifically-focused standard for all its authorizations. It must ensure strict pathogen rules and high standards around pig donors are always met. That rule requires the FDA to be the gold standard for authorizations, while it prioritizes working with transplant innovators committed to that standard in science.
This emerging field of science and the hope that it can bring is closer to reality than many of us could ever imagine. When the day comes that xenotransplantation is the new standard for transplant surgery, it will be a lifesaving turning point for thousands of Americans on waiting list.