By Jacob Balamut
David Bennett, a man who recently underwent the world’s first successful xenotransplantation organ surgery, died last month after a sudden and as yet unexplained period of rapid deterioration.
Bennett, who was 57 years old, had been suffering from end-stage heart disease. With limited options for treatment, he underwent an experimental emergency procedure to replace his damaged heart with a genetically modified pig’s heart. The pig was genetically modified to limit the likelihood that Bennett’s immune system would reject the heart.
Many researchers and clinicians alike see the potential for genetically modified animal organs to serve as a solution to our organ transplant and supply issues. The Health Resources and Services Administration estimates that 17 people die per day on the candidate waiting list. These deaths are the result of a lack of supply of organs, which has been a longstanding issue within the United States.
However, currently, the U.S. Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use”). The lack of approved xenotransplantation products stems from a lack of safety data and concerns regarding the potential for cross-species infections to occur.
In 2016, the FDA updated previously existing guidance for xenotransplantation. The purpose of the guidance was to inform the industry of how the FDA would be handling xenotransplantation applications and to provide recommendations. In order for xenotransplantation products to be approved, the following process must occur.