Scientists have reached a major milestone in animal-to-human transplant research as the U.S. Food and Drug Administration has approved the first human clinical trials for kidney transplants from genetically modified pigs.
According to biotech company eGenesis, the FDA has given a green light to its Investigational New Drug (IND) application to initiate a clinical trial evaluating its genetically engineered kidneys, referred to as EGEN-2784, in patients with end-stage kidney disease.
The approval marks a significant step forward in addressing the critical organ shortage facing thousands of Americans.
There are over 100,000 Americans on organ transplant waiting lists, with kidneys representing the most needed organ type. Current wait times for kidney transplants can extend several years, and many patients die before receiving a compatible organ.
Xenotransplantation — the process of transplanting organs, tissues or cells from one species to another — has long been considered a potential solution to the organ shortage crisis. Previous attempts using pig organs have faced significant challenges due to biological incompatibilities between species.
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The genetic modifications developed by eGenesis and other biotech companies aim to overcome these barriers by creating pig organs that more closely resemble human organs at the cellular level.
Those modifications include eliminating three glycan antigens to prevent hyperacute immune rejection, inserting seven human transgenes to regulate immune response and inactivating endogenous retroviruses within the pig genome to enhance safety.
eGenesis said a 67-year-old Massachusetts man who received an EGEN-2784 kidney in January surpassed seven months post-transplant, making him the world’s longest-living recipient of a genetically engineered porcine-derived organ.
The FDA approval allows researchers to begin testing the safety and effectiveness of these modified pig kidneys in human patients whereas the few transplants that have already occurred were completed under special guidelines.
