EGEN-5784 Porcine Liver With the Metra® ELC Device (NCT07429838)
A Phase 1, First-in-Human Safety and Proof-of-Concept Study to Evaluate EGEN-5784 Porcine Liver (Drug Product) in Combination With the Metra® Extra-Corporeal Liver Cross-Circulation Device in Participants With Acute-on-Chronic Liver Failure
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase 1, first-in-human (FIH) safety, proof-of-concept, two-part study of the genetically-engineered EGEN-5784 liver in combination with the metra® extra-corporeal liver cross-circulation (ELC) system in participants with Grade 2 to Grade 3 acute-on-chronic liver failure (ACLF) and hepatic encephalopathy Grade 1-3. The metra® device has been modified for the purposes of cross-circulation with an extra-corporeal porcine liver. The EGEN-5784 liver and metra® ELC device are designed to support liver function during the treatment period
Who can join: Review the eligibility criteria below.
Location: Washington University — St Louis, Missouri
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Washington University — St Louis, Missouri
- University of Wisconsin — Madison, Wisconsin
📞 Contact the Study Coordinator
Phone: (617) 941-7500
Email: PatientInfo@egenesisbio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Acute on Chronic Liver Failure (ACLF) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.