[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625992":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":34,"centralContacts":35,"locations":41,"responsibleParty":71,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":34,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":34,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":99,"whyStopped":34,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"eGenesis, INC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EGEN-5784 + metra® Extracorporeal Liver Cross-Circulation (ELC)","EXPERIMENTAL","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",[13,14],"Device: metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx)","Biological: EGEN-5784 (genetically engineered porcine liver)",[16,25],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx)","Perfusion circuit\u002Fdevice enabling extracorporeal cross-circulation between the participant and the EGEN-5784 porcine liver. Planned support up to 72 h in Part 1 and up to 120 h in Part 2 if no safety\u002Fstopping criteria are met, with ICU-level monitoring and protocol-defined operating parameters.",[9],[22,23,24],"OrganOx metra","OrganOx ELC","ELC system",{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","EGEN-5784 (genetically engineered porcine liver)","Viable porcine liver from a genetically engineered donor (EGEN-5784) used for temporary extracorporeal cross-circulation support. The liver is not implanted; it is perfused in a closed circuit with the participant under continuous monitoring and predefined stopping rules per protocol.",[9],[31,32,33],"xenogeneic porcine liver","EGEN-5784 liver","Genetically Engineered Porcine Liver",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Patient Inquires","CONTACT","617-941-7500","PatientInfo@egenesisbio.com",[42,58],{"facility":43,"status":34,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Washington University","St Louis","Missouri","63130","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-90.19789,38.62727,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":34,"phoneExt":34,"email":34},"Jeffery Crippin MD",{"facility":59,"status":34,"city":60,"state":61,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"University of Wisconsin","Madison","Wisconsin","53792",{"type":50,"coordinates":64},[65,66],-89.40123,43.07305,{"lat":66,"lon":65},[69],{"name":70,"role":38,"phone":34,"phoneExt":34,"email":34},"David Foley, MD",{"type":72,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[74],{"name":75,"class":6},"OrganOx Ltd.","100625992","phase-1-egen-5784-porcine-liver-with-the-metra-elc-device-100625992",false,"NCT07429838","EGEN-5784 Porcine Liver With the Metra® ELC Device","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","Key Inclusion Criteria:\n\n* Male or female, age 18 to 70 years, inclusive\n* Not eligible for transplantation at the time of enrollment\n* Diagnosis of Grade 2 to 3 ACLF according to the European Association for the Study of Chronic Liver Failure (EASL-CLIF) definition and Chronic Liver Failure Consortium-organ failure score (CLIF-C-OF) ≥10\n* Hepatic encephalopathy Grade 1 to 3 by West Haven Criteria\n* Written consent provided by participant or LAR (if participant lacks capacity, e.g., due to hepatic encephalopathy) prior to conduct of any study procedures\n\nKey Exclusion Criteria:\n\n* Prior solid organ transplant\n* Fulminant hepatic failure without underlying liver disease\n* Non-biological artificial liver extracorporeal liver support (e.g., molecular adsorbent recirculating system) or bioartificial liver support systems within 30 days prior to EGEN-5784 liver perfusion\n* Liver dysfunction due to trauma, or extra-hepatic cholestasis\n* Any uncontrolled ongoing active infection\n* History or active human immunodeficiency virus (HIV) infection or acute hepatitis B virus (HBV)\n* Chronic HBV or active hepatitis C\n* Diagnosis of cancer requiring active ongoing treatment, e.g., chemotherapy, radiation therapy\n* Severe concomitant cardiovascular disease defined as congestive heart failure Class III and IV\n* Significant acute or chronic pulmonary disease requiring ventilator support or diagnosed with chronic obstructive pulmonary disease Global Obstructive Lung Disease \\[GOLD\\] stage III or IV disorder\n* Active uncontrolled bleeding (i.e., any major blood loss requiring ≥2 units of pRBCs within the last 48 hours prior to screening)\n* Any other health condition, including illicit drug use, that would preclude participation in the study in the judgement of the PI","ALL","18 Years","70 Years",{"count":87,"type":88},20,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1","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",[94,95],"Acute on Chronic Liver Failure (ACLF)","Hepatic Encephalopathy (HE)",[97,98],"Extra-corporeal live cross-circulation","Metra","NOT_YET_RECRUITING","2026-05-05",{"date":102,"type":103},"2026-05-07","ACTUAL",{"date":105,"type":88},"2026-06",{"date":107,"type":88},"2028-01",{"name":5,"class":6},2]