New Delhi: Tim Andrews became the first person to live nine months with a genetically engineered pig-kidney, before eventually receiving a human transplant earlier this year. The 66-year-old is among the five patients with kidney failure who have received a genetically engineered pig kidney under an FDA-approved programme since March 2024.
The company behind the breakthrough is eGenesis, a US-based biotech company developing “human-compatible engineered organs” to address the shortage of organs for transplantation. In a press statement on 3 September, the company highlighted that Andrews set a new global record and his experience is now published in The Lancet.
“These patient outcomes provide important evidence that genetically engineered organs may provide sustained kidney function and dialysis independence while preserving the opportunity for a subsequent human transplant,” said eGenesis CEO Mike Curtis in a company statement.
Also read: Dwarka was Delhi’s middle class dream. Now it’s fighting traffic, garbage, water woes daily
A pig to the rescue
eGenesis’ statement comes as a clinical update to an ongoing study of EGEN-2784, the Company’s genetically engineered porcine kidney in collaboration with Mass General Brigham. The FDA has cleared eGenesis to conduct a three phase trial called “RESTORE” to see the effects of EGEN-2784 in 33 patients with kidney failure between 50 to 70 years. The company plans to begin the RESTORE study in the first half of 2027.
Over 800,000 Americans and millions of others worldwide suffer from end-stage kidney disease where organ transplantation is the only cure. But the severe shortage of donors means that people often have to undergo dialysis for months as they wait on long transplant lists for their turn. In 2024, only 28,000 kidney transplants were performed in the US. In such a scenario, genetically engineered pig-derived kidneys could be a promising solution.
“Our goal is to make transplantation available to patients when they need it, without being constrained by the limited supply of human donor organs. Collectively, these experiences provide important clinical evidence as we prepare to advance EGEN-2784 into the Phase 1/2/3 RESTORE study,” said Curtis.
Even if the porcine kidney is not a long term solution, at least it can help a patient stay off dialysis until they have another option. EGEN-2784 has been created to be compatible with the human body. Researchers have minimized immune rejection and added seven human transgenes to regulate the immune response to the kidney.
“The experience with these patients is providing invaluable insight into the potential role of xenotransplantation for people living with kidney failure. The sustained periods of dialysis independence are highly encouraging, and the successful transplantation of human donor kidneys following xenotransplantation demonstrates that this approach can preserve future treatment options. These findings provide an important foundation for the next stage of clinical development,” said Leonardo V Riella, medical director for kidney transplantation at MGH, who served as the principal investigator and led the clinical study.