US-based biotechnology company United Therapeutics has announced the first UKidney transplant into a living person.
The investigational xenokidney, branded as UKidney, is derived from a genetically edited pig with 10 gene modifications.
Six human genes are added to the pig genome to promote immune acceptance, while four pig genes are inactivated, three to prevent organ rejection and one to limit abnormal organ growth.
The 10-gene edited pig was developed by Revivicor, a subsidiary of United Therapeutics.
The latest transplant marks the fourth xenotransplant using United Therapeutics’ xeno organs into living humans, following two successful UHeart transplants at the University of Maryland in 2022 and 2023.
Earlier this year, the company completed a successful UThymoKidney transplant at NYU Langone Health.
The UKidney transplant was authorised by the US Food and Drug Administration (FDA) under the expanded access pathway.
Surgeons at NYU Langone Health, led by Robert Montgomery, performed the procedure.
The patient was evaluated at the University of Alabama at Birmingham by Jayme Locke, who also assisted in the surgery.
United Therapeutics chairperson and CEO Martine Rothblatt said: “The latest transplant of our UKidney is the culmination of decades of dedicated research and demonstrates the significant progress we are making in this revolutionary field.
“I am deeply grateful to Ms. Looney and her family and the exceptional team of scientists and surgeons who continue to advance this vital effort.”
United Therapeutics’ organ manufacturing efforts include four platforms, xenotransplantation, regenerative medicine, 3D organ bioprinting, and bio-artificial organs.
These platforms focus on hearts, kidneys, livers, and lungs. The goal is to address the critical shortage of transplantable organs for patients with end-stage organ disease.
United Therapeutics began xenotransplantation research in 2011, advancing three organ programmes, UKidney, UThymoKidney, and UHeart.
The biotechnology company opened a clinical-scale facility in Virginia and plans additional facilities to support clinical and commercial xenotransplantation efforts.
Preclinical work for the UKidney investigational new drug (IND) application was conducted at Johns Hopkins University.
This, along with data from Revivicor and United Therapeutics, will support the UKidney IND submission.
If approved by the US Food and Drug Administration (FDA), the biotechnology company plans to begin human clinical trials in 2025.
Additionally, clinical trials for UThymoKidney and UHeart are planned after completing the required preclinical studies.
