A surgical team at New York City-based NYU Langone Health has performed the first pig-to-human kidney transplant as part of a new clinical trial for patients with end-stage renal disease.
The multisite Expand study is the first U.S. clinical trial to evaluate the safety and efficacy of a genetically engineered pig kidney. The organ, developed by United Therapeutics Corp., features 10 gene edits — six human genes added to improve immune compatibility, and four porcine genes inactivated to reduce rejection risk and control growth.
Participants will be monitored for 24 weeks after transplant, with lifetime follow-up to assess kidney function and screen for zoonotic infections.
While other pig kidney transplants have been performed in the U.S. under the FDA’s Expanded Access pathway, the Expand study is the first to proceed under a formal clinical trial framework intended to support regulatory approval. One such Expanded Access program is underway at Mass General Brigham in Somerville, Mass., using organs developed by eGenesis.
The trial aims to offer an alternative for patients unlikely to receive a human donor kidney, according to a Nov. 3 news release.
