Overview
- United Therapeutics said the first transplant in its FDA-permitted study was performed successfully at NYU Langone Health.
- The Expand trial will start with six participants and could grow to as many as 50 as additional centers join.
- To protect privacy, researchers are not disclosing the surgery date or the participant’s identity.
- The investigational kidneys carry 10 gene edits, with four porcine genes inactivated and six human genes added, and recipients will be followed for 24 weeks with lifelong monitoring for function and infections.
- The FDA advanced to controlled trials after compassionate-use grafts showed temporary function, including reported durations of 130 and 271 days, and a separate eGenesis trial is expected to begin in the coming months.