EGEN-5784 Porcine Liver + Metra® ELC Device for Liver Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for individuals with serious liver problems. It combines a genetically modified pig liver (EGEN-5784) with the Metra® ELC Device to support liver function. Researchers aim to determine if this combination is safe and effective for those with specific types of liver failure and brain symptoms from liver disease. Suitable participants have experienced liver failure and confusion or memory issues due to their liver condition and are not currently eligible for a transplant. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that the EGEN-5784 liver and metra® ELC device are safe for treating liver failure?
Research has shown that the EGEN-5784 porcine liver, used with the metra® ELC system, is undergoing safety testing in humans. In studies using a deceased human model, the treatment assessed early immune responses and liver function support. These studies help researchers understand how this treatment might work in living people.
Currently, there is no information on the treatment's safety for living humans. However, the FDA has approved testing in humans, indicating that earlier research was promising enough to proceed. This approval suggests the treatment might be safe to try in people, but it doesn't guarantee safety.
As this is a Phase 1 trial, the primary goal is to determine the treatment's safety and how well participants can tolerate it. Participants should be aware that the focus at this stage is on safety, and there may be unknown risks.12345Why are researchers excited about this trial's treatments?
Unlike standard treatments for liver failure, which often rely on medications and supportive care like dialysis, EGEN-5784 uses a genetically engineered porcine liver in combination with the metra® Extracorporeal Liver Cross-Circulation (ELC) system. This innovative approach allows the porcine liver to temporarily perform the liver’s functions outside the body, potentially offering immediate support to patients with acute-on-chronic liver failure (ACLF). Researchers are excited because this method may provide quicker relief and bridge patients to recovery or transplant, addressing a critical gap in current treatment options.
What evidence suggests that the EGEN-5784 liver and metra® ELC device are effective for liver failure?
Research has shown that using the EGEN-5784 pig liver with the metra® ELC device may support liver function in animal studies. Tests in pigs demonstrated that this system can temporarily assist the liver, improving its function during sudden liver failure. Early experiments indicate that the specially engineered pig liver works well with the ELC device, providing essential support. In this trial, participants with Grade 2-3 ACLF will receive extracorporeal cross-circulation using the EGEN-5784 connected via the metra® ELC system, in addition to institutional standard of care. Although human studies provide limited information, these early results are promising for addressing sudden liver problems in people with ongoing liver issues.12346
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 70 with moderate to severe acute-on-chronic liver failure and mild to moderate confusion from liver disease, who are not eligible for a liver transplant. Participants or their representatives must give consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo extracorporeal liver cross-circulation using the EGEN-5784 porcine liver and metra® ELC system
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and liver-related laboratory parameters
What Are the Treatments Tested in This Trial?
Interventions
- EGEN-5784
- metra® ELC Device
Trial Overview
The study tests the safety of using a genetically engineered pig liver (EGEN-5784) connected outside the body through the metra® ELC device to temporarily support failing human livers. This is an early-phase, first-in-human trial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with Grade 2-3 ACLF receive extracorporeal cross-circulation using a genetically engineered porcine liver (EGEN-5784) connected via the metra® ELC system, in addition to institutional standard of care. No comparator arm is included
Find a Clinic Near You
Who Is Running the Clinical Trial?
eGenesis, INC
Lead Sponsor
OrganOx Ltd.
Industry Sponsor
Citations
EGEN-5784 Porcine Liver With the Metra® ELC Device
The study will assess the safety of the ELC used to support liver function in patients with acute on chronic liver failure. Safety will be assessed based on ...
EGEN-5784 Porcine Liver + Metra® ELC Device for ...
This is a Phase 1, first-in-human (FIH) safety, proof-of-concept, two-part study of the genetically-engineered EGEN-5784 liver in ...
eGenesis and OrganOx Announce U.S. FDA Clearance of ...
eGenesis' human-compatible, genetically engineered porcine liver, used in combination with OrganOx's ELC system to support the function of a ...
Extracorporeal liver cross-circulation using transgenic ...
This study used the ELC platform to evaluate early immune responses and assess xenogeneic liver physiological support in a human decedent model. Four human ...
Award NIHR208501
A novel ELC system (metra-ELC) has been developed by modifying the OrganOx metra normothermic perfusion device. In a porcine liver failure model, metra-ELC ...
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organox.com
organox.com/news/egenesis-and-organox-announce-u-s-fda-clearance-of-ind-application-for-the-treatment-of-patientseGenesis and OrganOx Announce U.S. FDA Clearance of ...
eGenesis and OrganOx Announce U.S. FDA Clearance of IND Application for the Treatment of Patients with Acute-On-Chronic Liver Failure.
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