[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"eGenesis, INC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28],"Acute on Chronic Liver Failure (ACLF)","Hepatic Encephalopathy (HE)",[30,31],"Extra-corporeal live cross-circulation","Metra","NOT_YET_RECRUITING","2026-05-05",{"date":35,"type":36},"2026-05-07","ACTUAL",{"date":38,"type":21},"2026-06",{"date":40,"type":21},"2028-01",{"name":42,"class":43},"eGenesis, INC","INDUSTRY",2,""]