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# FDA Clears eGenesis Perfusion Trial
- URL: https://www.fdaweb.com/fda-clears-egenesis-perfusion-trial/
- Published: 2025-04-15T12:00:00.000Z
- Updated: 2026-09-14T15:09:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159007

FDA has cleared an eGenesis and OrganOx IND for a first-in-human clinical trial to evaluate a novel perfusion system using a genetically engineered porcine liver to treat patients with acute-on-chronic liver failure and no transplant option. An eGenesis [statement](https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.businesswire.com/news/home/20250415526464/en/eGenesis-and-OrganOx-Announce-U.S.-FDA-Clearance-of-IND-Application-for-the-Treatment-of-Patients-with-Acute-On-Chronic-Liver-Failure&ved=2ahUKEwiPnc3Mq9qMAxVYE1kFHaSWLhIQFnoECBYQAQ&usg=AOvVaw1X2PdRZXe5Jijk7Ez2X6Kx) says its EGEN-5784, a human-compatible, genetically engineered porcine liver, will be used in combination with the OrganOx extracorporeal cross-circulation system for patients suffering from decompensated liver function in an intensive care setting.

The company says that to date four perfusions with decedent recipients have been performed as part of the PERFUSE-2 study. Up to 20 patients are to be enrolled in the Phase 1 study across multiple U.S. centers, the company says.