[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616995":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":19,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":19,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":19,"maxAge":19,"enrollmentInfo":54,"targetDuration":19,"studyType":57,"phases":58,"briefSummary":61,"conditions":62,"keywords":19,"overallStatus":28,"whyStopped":19,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Beijing Friendship Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CiPS-BAL","EXPERIMENTAL","Chemically induced pluripotent stem cells biological Artificial Liver",[13],"Biological: Chemically induced pluripotent stem cells biological Artificial Liver",[15],{"type":16,"name":11,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Participants will receive CiPS-BAL therapy, a novel bioartificial liver treatment that combines functional hepatocytes derived from chemically induced pluripotent stem cells (CiPS) with an extracorporeal bioartificial liver device. The CiPS-derived hepatocytes are generated and cultured in vitro under Good Manufacturing Practice (GMP) conditions and subsequently loaded into the bioartificial liver device prior to treatment.\n\nEach treatment session utilizes 1 × 10¹⁰ functional hepatocytes. Therapy is administered via central venous access (e.g., femoral, internal jugular, or subclavian vein) for 4-8 hours per session. The planned treatment frequency is one session, with the possibility of additional sessions depending on clinical response and safety evaluation.\n\nStandard medical therapy for liver failure or small-for-size syndrome will be provided concomitantly. Participants will be closely monitored for safety, tolerability, and changes in clinical and laboratory parameters throughout",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Wan-Ting Zhang","CONTACT","+86 13699189579","13699189579@163.com",[27],{"facility":5,"status":28,"city":29,"state":19,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Beijing","101102","China","CN",{"type":34,"coordinates":35},"Point",[36,37],116.39723,39.9075,{"lat":37,"lon":36},[40],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":41},"1699189579@163.com",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Li-Ying Sun","Director of Department of Critical Liver Diseases","100616995","phase-1-safety-and-tolerability-study-of-a-novel-bioartificial-liver-in-liver-failure-and-small-for-size-syndrome-100616995",false,"NCT07312864","Safety and Tolerability Study of a Novel Bioartificial Liver in Liver Failure and Small-for-Size Syndrome","A Clinical Trial Assessing the Safety, Tolerability, and Exploratory Efficacy of a Novel Bioartificial Liver Therapy in Patients With Liver Failure or Small-for-Size Syndrome","Inclusion Criteria:\n\n* Patients diagnosed with liver failure (including acute, subacute\u002Facute-on-chronic, and chronic liver failure) or small-for-size syndrome\n\nExclusion Criteria:\n\n* Presence of severe extrahepatic systemic end-stage diseases\n* Uncontrollable infection or active bleeding\n* Pregnant or breastfeeding women\n* History of allergy or known severe hypersensitivity to CiPSC-derived cell products or blood products\n* Peripheral vascular collapse leading to inability to obtain venous access or collect blood\n* Unable or unwilling to provide informed consent or unable to comply with study requirements\n* Unwilling to receive CiPSC-based therapy","ALL",{"count":55,"type":56},12,"ESTIMATED","INTERVENTIONAL",[59,60],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety and tolerability of a novel bioartificial liver (CiPS-BAL) in patients with liver failure or small-for-size syndrome. The study will also collect preliminary data on clinical outcomes and laboratory parameters during treatment. The main questions it aims to answer are:\n\nIs the novel bioartificial liver system safe and well tolerated in patients with liver failure or small-for-size syndrome?\n\nWhat effects does the treatment have on liver function and other clinical and laboratory indicators?\n\nResearchers will treat participants with the CiPS-BAL system, which uses hepatocytes derived from chemically induced pluripotent stem cells (CiPS) within a bioartificial liver device.",[63,64],"Liver Failure","Small-for-Size Syndrome","2026-04-15",{"date":67,"type":68},"2026-04-20","ACTUAL",{"date":70,"type":68},"2025-12-01",{"date":72,"type":56},"2028-12-31",{"name":5,"class":6},1]