Hope in the fight against global organ shortage: Pig kidneys cleared for clinical trials

The US Food and Drug Administration (FDA) has approved the first large-scale clinical trial of genetically engineered pig kidney transplants. This shifts testing from isolated cases to systematic evaluation in multiple patients. The decision could mark a breakthrough for xenotransplantation, a field widely viewed as a potential solution to the global organ shortage.

On September 8, Cambridge-based biotech company eGenesis announced that the FDA had granted Investigational New Drug (IND) approval for its EGEN-2784 pig kidney. The clearance paves the way for a Phase 1/2/3 clinical trial designed to evaluate the organ’s safety, tolerability and effectiveness over a 24-week period.

Unlike earlier one-off transplants, the new trial will involve multiple patients treated in parallel within a structured study. The research is led by an interdisciplinary team at Massachusetts General Hospital, including transplant specialist Leonardo V. Riella and surgeons Tatsuo Kawai and Nahel Elias, with industry partners such as Eledon, Apellis and Karius also supporting the project.

Early successes with pig kidney transplants

Doctors at Massachusetts General Hospital have already reported early successes. Sixty-seven-year-old Tim Andrews has been living without dialysis for more than seven months since January 2025 – longer than any previous patient with a pig organ. Meanwhile, fifty-four-year-old Bill Stewart, who received an EGEN-2784 kidney in June 2025, was discharged just one week after surgery.

The eGenesis organs are developed using a specialized genome-editing platform that integrates three types of modifications: removing rejection-causing antigens, adding human genes to improve compatibility and inactivating endogenous retroviruses. According to eGenesis, it is currently the only company applying all three strategies at once.

Hope in the fight against organ shortage

According to eGenesis, only 28,000 kidney transplants were performed in 2024, even though more than 800,000 Americans suffered from severe kidney disease. The five-year mortality rate for dialysis patients exceeds 50% – higher than that of many cancers. And the problem extends far beyond the United States, representing a global challenge.

Early xenotransplantation attempts using monkey organs in the 1960s failed, but today’s combination of genome editing and rigorous clinical testing marks a major milestone. eGenesis CEO Mike Curtis described it as “a decisive step toward overcoming the global organ shortage.” If the safety and effectiveness of EGEN-2784 are confirmed, the long-standing goal of reliable, readily available donor organs could finally become reality.