[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"decompensated-liver-cirrhosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:decompensated-liver-cirrhosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,71,120,148,178,204],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100593160","effect-of-single-vs-repeated-cycles-of-a-combination-of-granulocyte-colony-stimulating-factor-and-darbepoetin-vs-standard-medical-treatment-on-immunometabolic-profile-in-patient-with-early-decompensated-cirrhosis-100593160",false,"NCT07002827","Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis.","Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis -A Pilot Randomised Controlled Trial.","Inclusion Criteria:\n\n1. Age 18-70 years\n2. Decompensated cirrhosis patients\n3. Uncomplicated ascites,\n4. CTP ≤ 9B and MELD \\\u003C16\n5. BM Hematopoietic stem cell reserve \\> 0.4\n6. Given informed consent\n\nExclusion Criteria:\n\n1. Patients with age less than 18 years or more than 65 years\n2. Lack of informed consent\n3. Patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients\n4. Evidence of alcoholic hepatitis\u002Factive alcohol abuse last intake ≤ 3 months\n5. Suspected autoimmune hepatitis (ANA\u002FASMA-positive in titers 1:80 and\u002F or IgG 1.5 times upper limit of normal),\n6. Hemolytic anaemia -Sickle cell disease or thalassemia\n7. Patients with Grade III ascites \u002Fcomplicated ascites\n8. Patients with large spleen (size ≥ 15cm)\n9. Recent variceal bleeding in less than 42 days\n10. Patients with any focus of sepsis as proven by culture positivity or presence of spontaneous Bacterial Peritonitis (SBP)\n11. H\u002Fo Seizures\n12. Hepatocellular Carcinoma (HCC) or other malignancy\n13. Acute Kidney Injury (AKI) with serum Creatinine \\>1.5 mg\u002F dl,\n14. Multi-organ failure,\n15. Hepatic Encephalopathy or prior history of HE in less than 6months\n16. HIV seropositivity,\n17. Uncontrolled essential hypertension, CAD \u002FStroke\n18. Massive hydrothorax\n19. Pregnancy\n20. Viral etiology of liver disease\n21. Chronic kidney disease\n22. Portal vein thrombosis\n23. Planned for LT\n24. Bone marrow hematopoietic stem cells \\\u003C 0.4","ALL","18 Years","70 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Exogenous growth factor-mobilized bone marrow (BM) stem cells(G-CSF) and DARBEPOETIN use have shown a differential response in the management of decompensated cirrhosis (DC) with improved survival, CTP and MELD scores. This study was designed to evaluate potential clinical benefit of repeated cycles of granulocyte-colony stimulating factor (G-CSF) and DARBEPOETIN versus single cycle on delta change in immunometabolic profile of patients at 6 months assessed in terms of -Change in innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation .",[27],"Decompensated Liver Cirrhosis","RECRUITING","2026-05-19",{"date":31,"type":32},"2026-05-22","ACTUAL",{"date":34,"type":32},"2025-06-04",{"date":36,"type":21},"2026-12-30",{"name":38,"class":39},"Institute of Liver and Biliary Sciences, India","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":40},"100574875","phase-2-statin-and-beta-blocker-use-in-patients-with-decompensated-cirrhosis-100574875","NCT06764966","Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis","A Pilot Study of Statin and Beta Blocker Use in Patients With Decompensated Cirrhosis","Inclusion Criteria:\n\n* Patients age of 18 years or older diagnosed with any form of decompensated liver disease defined as ascites, hepatic encephalopathy, or variceal bleed presenting at Charleston Area Medical Center (CAMC) Memorial Hospital or CAMC-Gastroenterology Liver Clinic\n* Currently on an non-selective beta-blockers agreeing to have their liver disease managed by CAMC-Gastroenterology Liver Clinic as an outpatient for the 12-month follow-up period.\n\nExclusion Criteria:\n\n* Any patient \\\u003C18 years of age\n* Patients with hepatocellular carcinoma\n* Patients with ongoing alcohol use (self-reported consumption of more than one alcoholic drink per week)\n* Patients exhibiting high-risk behaviors that could put them at risk for complications including IV substance use and history of medication non-adherence\n* Patients currently on statin therapy\n* Patients with a history of statin intolerance\n* Patients on the waitlist for liver transplantation\n* Patients taking medications with known drug interactions with statins\n* Patients not able to give informed consent or patients belonging to vulnerable categories as the Federal Regulations or Common Rule",{"count":49,"type":21},50,[51],"PHASE2","Decompensated cirrhosis (liver disease) occurs when liver function decreases to the extent that serious complications develop and can include internal bleeding, fluid buildup in the abdomen, or mental confusion. This reduced decreased liver function subsequently decreases life expectancy. There is a critical need for strategies to delay progression to decompensation and reduce the occurrence of serious complications. Currently, limited therapeutic options are available for managing decompensated liver disease, with beta-blockers (BB) being the only proven medication with significant benefits in preventing disease progression. Statins have been historically under- prescribed in cirrhosis due to concerns of liver damage. However, there is emerging evidence that statin use may be beneficial and able to lessen liver disease worsening, with studies demonstrating its safety. Thus, we aim to conduct a pilot randomized controlled trial (RCT) study of 50 subjects comparing the outcomes of decompensated cirrhotic patients receiving the statin, atorvastatin, and a non-selective beta-blocker (NSBB) versus those receiving NSBB plus placebo. Both groups will be followed for 12 months to investigate the feasibility, safety, and efficacy of combination therapy.",[27,54,55,56],"Cirrhosis","Decompensated Cirrhosis of Liver","Decompensated Cirrhosis and Ascites",[58,59,60,61,54],"Decompensated Cirrhosis","Decompensated Liver Disease","Statins","Beta-Blockers","2026-02-23",{"date":64,"type":32},"2026-02-25",{"date":66,"type":32},"2025-09-09",{"date":68,"type":21},"2027-03",{"name":70,"class":39},"CAMC Health System",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":92,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"100579393","phase-1-rtx001-autologous-engineered-macrophages-for-liver-cirrhosis-100579393","NCT06823713","RTX001 Autologous Engineered Macrophages for Liver Cirrhosis","An Open-label Phase 1\u002F2 Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of RTX001 Autologous Macrophages in Participants With Liver Cirrhosis Who Have Hepatic Decompensation (EMERALD)","EMERALD","Individuals eligible to participate in this study must meet the following criteria:\n\nInclusion Criteria:\n\n1. Male or female age ≥18-75 years.\n2. Patient confirms willingness\u002Fability to comply with all study procedures.\n3. Diagnosis of liver cirrhosis based on at least one of:\n\n   1. Clinical and radiological features that correlate with a diagnosis of cirrhosis.\n   2. Transient elastography (Fibroscan) \\>15 kPa.\n   3. Previous liver biopsy confirming histological features of cirrhosis.\n4. Aetiology of liver disease of steatotic liver disease including MASLD or Met-ALD or ALD\n\n   a. Participants with alcohol-related liver disease (ALD or Met-ALD) only if they are confirmed to not be drinking alcohol above Met-ALD limits defined in this protocol. (N.B. No more than 34% of the total treated participants in this protocol will be ALD \\[excludes Met-ALD\\]).\n5. Hospitalised as an inpatient for a recent major hepatic decompensation event including ascites, hepatic encephalopathy, variceal bleed, HRS-AKI or SBP, this being the only hospitalisation for an hepatic decompensation event hospitalisation within the last 6 months, and where recent is defined as within 6 weeks of hospital discharge.\n6. Outpatient: Medically refractory ascites (ONLY), that recurs (i.e., second therapeutic LVP) within a 6-month period. Medically refractory ascites is defined by the repeated (≥2) need for LVP (i.e., therapeutic, not diagnostic) at least once per 8 weeks despite best medical attempts to control the ascites by sodium restriction and diuretic treatment, as confirmed by the Investigator. Onset is defined as the date of the second therapeutic LVP.\n7. Confirmatory PEth alcohol test \\\u003C200 ng\u002Fml\n8. MELD score of 12-20 taken within two weeks of 'qualifying' decompensation event.\n9. No known contradictions to filgrastim or leukapheresis procedure.\n10. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n11. Willing and able to give signed informed consent, and if applicable assent.\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nExclusion Criteria:\n\n1. Liver cirrhosis due to:\n\n   1. any viral hepatitidies, or\n   2. autoimmune and cholestatic aetiologies including, but not limited to, primary biliary cholangitis and primary sclerosing cholangitis.\n2. Acute liver disease in the absence of underlying liver cirrhosis, including, but not limited to, drug induced liver injury.\n3. Any current organ failure requiring more than outpatient supportive care, and not associated with the participant's qualifying hepatic decompensation event.\n4. Known splenomegaly ≥16 cm.\n5. Thrombocytopenia \\\u003C50×109\u002FL.\n6. Presence or suspicion of any of the following co-morbidities:\n\n   1. History of liver transplantation or other organ transplant.\n   2. ACLF.\n   3. Sepsis (with positive microbial cultures) or as defined by the Principal Investigator, unless stable and is at least 4 weeks after having completed a full course of IV antibiotics.\n   4. Known human immunodeficiency virus.\n   5. Known syphilis.\n   6. Known human T-lymphotropic virus 1.\n   7. Pulmonary embolism.\n   8. Hepatocellular carcinoma, or any active malignant disease within the last five years, (excluding non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, benign polyps etc.).\n   9. Co-hepatic morbidities e.g., portal vein thrombosis.\n   10. Participants with hepatic hydrothorax are excluded unless it is a small hydrothorax, not clinically apparent, that is detected incidentally by radiologic evaluation that does not require clinical intervention.\n   11. Chronic renal impairment (on dialysis) or unresolved AKI.\n   12. Acute or chronic heart failure (New York Heart Association Grade III\u002FIV).\n   13. Porto-pulmonary hypertension.\n   14. Severe chronic lung disease e.g., chronic obstructive pulmonary disease or interstitial lung disease where the forced expiratory volume in the first second (FEV1) is less than 50% and\u002For FEV1\u002Fforced vital capacity is less than 60%.\n   15. Hepatopulmonary syndrome.\n   16. Previous or current treatment with multiple infusions of albumin for therapeutic intent. \\[Use of albumin infusion at the time of large volume paracentesis for circulatory support is allowed.\\]\n   17. Significant untreated\u002Funstable psychiatric disease.\n   18. Transjugular intrahepatic portosystemic shunt (TIPSS).\n7. As judged by the Investigator, any evidence of intercurrent illness that is either life threatening or of clinical significance such that it might limit compliance with study procedures.\n8. Current or planned use of immunomodulators or immunosuppressive medication; note: low doses of corticosteroids up to 10 mg\u002Fkg\u002Fday prednisone or equivalent are permitted, or inhaled steroids to manage asthma.\n9. Received a gene or cell therapy at any time.\n10. Current or planned use of a live attenuated vaccines four weeks or fewer prior to enrolment (and for 3 months after the last administered dose of RTX001).\n11. Received any investigational product within the past 6 months, or five half-lives (whichever is longer) or participated in another investigational interventional study within 30 days prior to the screening visit.\n12. Participants with a known hypersensitivity to dimethyl sulfoxide (DMSO).\n13. Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.\n14. For female participants only - pregnant or breast-feeding or plans to become pregnant over the next year, or of childbearing potential and unwilling to comply with contraceptive requirements.\n15. Alcohol misuse in the period between identification of the participant as potentially suitable for this study to Screening (Visit 1), defined as alcohol intake greater than three units\u002Fday for females and four units\u002Fday for males, or binge drinking (\\>14 units\u002Fday) as determined by the Investigator. N.B. One unit is equivalent to 14 g of alcohol: a half-pint (\\~240 mL) of beer, one glass (125 mL) of wine or one (25 mL) measure of spirits.\n16. Intake of non-medically supervised drugs of abuse that are judged (by the Investigator) to be a high risk to the participants acute health or which makes the participant likely to be non-compliant with follow-up.","75 Years",{"count":81,"type":21},30,[83,51],"PHASE1","The purpose of this study is to assess the safety and efficacy of RTX001 in patients with end-stage liver disease. This study is the first time RTX001, a macrophage cell therapy engineered to have an anti-inflammatory and anti-fibrotic effect, will be given to humans.",[86,87,88,89,90,27,58,91],"End-stage Liver Disease (ESLD)","Cirrhosis, Liver","Cirrhosis, Decompensated","Liver Diseases","Fibrosis and Cirrhosis of Liver","Steatotic Liver Disease",[93,94,95,96,97,27,98,99,100,101,102,103,104,105,106,107,108,91],"Liver cirrhosis","Cirrhotic","Hepatic Cirrhosis","Chronic Liver Disease","Liver Fibrosis","Child-Pugh Score","MELD Score","Liver Function Tests","Hepatic Encephalopathy","End Stage Liver Disease (ESLD)","Variceal Bleeding","Jaundice","Retractable Ascites","Autologous","Cell Therapy","Macrophage","2026-01-27",{"date":111,"type":32},"2026-01-28",{"date":113,"type":32},"2024-10-15",{"date":115,"type":21},"2028-11-29",{"name":117,"class":118},"Resolution Therapeutics Limited","NETWORK",14,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":127,"enrollmentInfo":128,"targetDuration":130,"studyType":131,"phases":4,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":40},"100424007","tips-in-patients-with-decompensated-liver-cirrhosis-100424007","NCT04801290","TIPS in Patients With Decompensated Liver Cirrhosis","Benefits and Limitations of Transjugular Intrahepatic Portosystemic Shunts (TIPS) in Patients With Decompensated Liver Cirrhosis","Inclusion Criteria:\n\n* Liver cirrhosis\n* Indication for TIPS insertion\n* Treatment at the Department of Gastroenterology, Hepatology and Endocrinology of Hannover Medical School\n* Informed consent\n\nExclusion Criteria:\n\n* Pregnancy or Lactation\n* Age \\\u003C18 years\n* Lack of Informed consent\n* Symptomatic anemia with Hb \\\u003C7g\u002Fdl","99 Years",{"count":129,"type":21},250,"12 Months","OBSERVATIONAL","This is a single center patient registry of patients receiving a transjugular intrahepatic portosystemic shunt (TIPS) at Hannover Medical School. By collecting and analyzing clinical data as well as blood samples, the overall aim is to optimize TIPS therapy (e.g. specify selection criteria).",[27],[135,136,137,138,93],"Portal hypertension","TIPS","Refractory ascites","Variceal bleeding","2025-09-10",{"date":141,"type":32},"2025-09-16",{"date":143,"type":32},"2019-08-29",{"date":145,"type":21},"2027-12",{"name":147,"class":39},"Hannover Medical School",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":156,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":158,"conditions":159,"keywords":163,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100568007","leopard-training-and-validation-data-collection-study-100568007","NCT06675604","LEOPARD Training and Validation Data Collection Study","Data Collection to Design and Validate LEOPARD Predictive Models of Delisting in Liver Transplant Candidates","LEOPARD TVDCS","Inclusion Criteria:\n\n* Adult \\[age 18;70\\] patients listed for:\n\n  * decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset 1) OR\n  * other chronic end-stage liver diseases requiring LT, to be listed under a MELD-based allocation system (examples: primary biliary cholangitis, primary sclerosing cholangitis etc…) (subset 2) OR\n  * HCC\\* as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis (subset 3). (HCC diagnosed on Barcelona\u002FEASL criteria or histologically proven. HCC meeting or not Milan criteria, as per center practice.)\n* Patients registered on national waiting lists under the MELD offering schemes, regardless of extra MELD points and MELD exceptions are affected or not.\n* Patient (or trusted person, family member or close relation, if the patient is unable to be informed) who has been informed and did not express opposition to data collection\n\n(\\*Of note, enrolment of patients with T1 tumors (1 single tumor \\\u003C 2 cm diameter) not amenable to loco-regional therapies because of decompensation, and prioritized under the MELD system, will be allowed in Subset 1.)\n\nExclusion Criteria:\n\n* Tumor vascular invasion (portal or hepatic veins) evidenced by imaging at pre transplantation work-up, including portal vein thrombosis stage 1\n* Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional imaging (18 FDG PET CT\u002FMRI) or histologically proven\n* Patients who are under safeguard of justice or tutorship or curatorship\n* Patient on AME (state medical aid)\n* Participation to LEOPARD PVC 1 study of WP2",{"count":157,"type":21},4500,"Intro:\n\nThe present clinical research protocol is part of the LEOPARD European project (Grant n° 101080964 Horizon Europe) which aims to design and validate new predictive models of mortality among liver transplantation (LT) candidates. MELD based-liver graft allocation systems have become increasingly inaccurate over the last decade to predict mortality\u002Fdropout of liver transplantation (LT) candidates on the waitlist (WL). Wide disparities in mortality\u002Fdropout on the WL also exist across European countries, ranging from 5 to 30% according to transplantation indications and countries. In this setting, the European Commission- Horizon Europe funded-LEOPARD project intends to design new, 2nd generation, AI-machine learning-based predictive models of delisting in LT candidates, to better serve on time patients with the highest risk of dropout on the WL and to improve equity of access to LT across Europe.\n\nHypothesis\u002FObjective:\n\nThe scientific justification of the LEOPARD TVDCS is therefore to collect a large set of data in liver transplantation candidates listed in Europe a) to design and b) to validate LEOPARD 2nd generation AI-based predictive models of mortality\u002Fdropout The primary objective is to develop new predictive models of mortality\u002Fdrop out on the waitlist in patients with decompensated cirrhosis, or other end-stage chronic liver diseases, and in patients listed for Hepato-cellular carcinoma (HCC).\n\nMethod:\n\nLongitudinal multicenter prospective health care data collection cohort study in 2 sets : Training\u002Fdevelopment set : Prospective health care data collection in 3,000 patients listed in 50 centres across 7 countries and Validation set: Prospective health care data collection in 1,500 subsequent patients listed in the same 50 centres.",[27,160,161,162],"Primary Biliary Cholangitis","Primary Sclerosing Cholangitis","Hepato-cellular Carcinoma",[164,165,166,167],"Liver transplantation","predictive models","data collection cohort","liver transplantation candidates","2025-05-06",{"date":170,"type":32},"2025-05-09",{"date":172,"type":32},"2025-02-04",{"date":174,"type":21},"2029-02-04",{"name":176,"class":39},"Assistance Publique - Hôpitaux de Paris",22,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":186,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":194,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},"100571670","leopard-prospective-validation-cohort-1-100571670","NCT06723275","LEOPARD Prospective Validation Cohort 1","Validation of LEOPARD Predictive Models of Delisting in Liver Transplant Candidates: the LEOPARD Longitudinal Multicentre Prospective Validation Cohort 1, with Bio- and Tissue Collection","LEOPARD PVC1","Inclusion Criteria:\n\n* Adult \\[age 18;70\\] patients listed for:\n\n  * decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset1) OR\n  * other end-stage liver diseases requiring LT, listed under MELD offering schemes (subset 2), including notably but not exclusively cholestatic diseases, primary biliary cholangitis, primary sclerosing cholangitis (subset 2) OR\n  * HCC as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis (subset 3). (HCC diagnosed on Barcelona\u002FEASL criteria or histologically proven. HCC meeting or not Milan criteria, as per center practice.)\n* Patients registered on national waiting lists under the MELD offering schemes, regardless of extra MELD points are affected or not.\n* Patient (or trusted person, family member or close relation, if the patient is unable to express consent) who has been informed and signed the informed consent.\n* Patient affiliated with a health insurance scheme (beneficiary or entitled party).\n\nExclusion Criteria:\n\n* Tumor vascular invasion (portal or hepatic veins) evidenced by imaging on pre transplantation work-up, including PVT stage 1\n* Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional imaging (18 FDG PET CT\u002FMRI) or histologically proven\n* Women who are pregnant or nursing\n* Patients who are under safeguard of justice or tutorship or curatorship\n* Patient on AME (state medical aid)\n* Participation in another trial including other studies proposed as part of the European LEOPARD project (cohort associated to WP1 \\& WP5 (\"LEOPARD TVDCS\") or being in the exclusion period following previous interventional research involving the human person, if applicable",{"count":187,"type":21},630,"Intro:\n\nThe present clinical research protocol is part of the LEOPARD European project (Grant n° 101080964 Horizon Europe) which aims to design and validate new predictive models of mortality among liver transplantation (LT) candidates.\n\nMELD based-liver graft allocation systems have become increasingly inaccurate over the last decade to predict mortality\u002Fdropout of liver transplantation (LT) candidates on the waitlist (WL). Wide disparities in mortality\u002Fdropout on the WL also exist across European countries, ranging from 5 to 30% according to transplantation indications. In this setting, the European Commission- Horizon Europe funded-LEOPARD project intends to design new, 2nd generation, AI-machine learning-based predictive models of delisting in LT candidates, to better serve on time patients with the highest risk of dropout on the WL and to improve equity of access to LT across Europe.\n\nHypothesis\u002FObjective The scientific justification of the LEOPARD PVC1 is therefore\n\n1. to build an external cohort of LT candidates to test and validate the LEOPARD models, therefore providing robust evidence for adoption of LEOPARD models by Organ Sharing Organizations (OSOs).\n2. to collect granular data, bio- and tissues sampes and images to test last-generation OMICs predictors and radiomics, therefore opening the door to design of 3rd generation, precision medicine-based predictive models.\n\nThe primary objective of the LEOPARD longitudinal study is to test and validate AI-based 2nd generation LEOPARD predictive models of mortality\u002Fdrop out on the waitlist in patients with decompensated cirrhosis, or other end-stage chronic liver diseases, and in patients listed for HCC.\n\nMethod Multicenter Prospective longitudinal study in up to 630 enrolments (in case of replacing participants after inclusion) to obtain 600 patients meeting selection criteria, in 30 hospitals in 5 European countries including France, Italy, The Netherlands, Belgium and Germany.",[27,160,161,162],[164,191,192,193],"Predictive models","Liver transplantation candidates","prospective longitudinal study","NOT_YET_RECRUITING","2024-12-10",{"date":197,"type":32},"2024-12-13",{"date":199,"type":21},"2025-01",{"date":201,"type":21},"2027-10",{"name":176,"class":39},5,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":194,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":4},"100512171","phase-1-safety-of-umbilical-cord-mesenchymal-stem-cells-uc-msc-in-patients-with-decompensated-hepatitis-b-cirrhosis-100512171","NCT05948982","Safety of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Decompensated Hepatitis B Cirrhosis","A Clinical Trial to Evaluate the Safety, Tolerance and Efficacy of aCell Inj. of Allogeneic UC-MSCs in Patients With Decompensated Hepatitis B Cirrhosis","Inclusion Criteria:\n\n* 18 to 75 years old (including borderline values) at screening, regardless of gender\n* Diagnosed with decompensated hepatitis B cirrhosis according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition)\n* There's no significant reduction in cirrhotic symptoms or no significant improvement in quality of life score after more than 3 months of strict medical conservative treatment\n* HBV DNA ≤ 1000 IU\u002FmL at the time of screening\n* Fully understand the informed consent form, voluntarily subject to the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n* other causes of cirrhosis, such as alcoholic hepatitis, viral hepatitis C, autoimmune hepatitis and metabolic-related fatty liver disease\n* Child-Pugh score \\>12;\n* History of malignancy of the liver or other organs, or a family history of liver malignancy in three generations of immediate family members;\n* Current serious medical conditions that would affect your safety and treatment efficacy assessment as determined by the investigator, such as: Class II or higher abnormal cardiac function (NYHA criteria), cardiovascular disease such as ischemic heart disease (e.g., myocardial infarction or angina), poorly controlled diabetes (fasting glucose ≥ 10 mmol\u002FL or glycated hemoglobin (HbA1c) ≥ 8%), serum creatinine \\> 2 times the upper limit of normal (ULN), etc;\n* Recent uncontrolled gastrointestinal bleeding (e.g., severe bleeding tendency or active bleeding within 3 months prior to screening, or clinically significant upper gastrointestinal hemorrhage event within 4 weeks prior to screening), as determined by the investigator to be unsuitable for participation in this trial;\n* Have had hepatic encephalopathy or hepatorenal syndrome within 3 months prior to screening\n* Spontaneous peritonitis or a more severe active infection within 2 weeks prior to the trial\n* Positive infectious disease test (serum anti-HIV antibody, anti-HCV antibody, syphilis antibody either positive) or active tuberculosis;\n* Those who have received human albumin within 3 weeks prior to the first infusion of the test drug;\n* Those who have the history of venous thrombosis or pulmonary embolism\n* Drug addicted or alcohol abusers;\n* Women who are pregnant or breastfeeding;\n* Persons with a history of severe drug allergy or hypersensitivity;\n* History of a serious mental disorder, including uncontrolled major depression or controlled or uncontrolled psychosis, within 24 months prior to screening;\n* Those who have participated in other interventional clinical trials within 3 months prior to screening or are participating in other interventional clinical trials, or who have received prior stem cell therapy\n* Those who are proposed for liver transplantation within 3 months;\n* Other conditions that, in the opinion of the investigator, are not suitable for participation in this clinical trial.",{"count":212,"type":21},18,[83,51],"The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis, and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with decompensated hepatitis B cirrhosis in the future.\n\nParticipants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells.",[27],[217,218],"Decompensated hepatitis B cirrhosis","Human Umbilical Cord Mesenchymal Stem Cells","2023-07-13",{"date":221,"type":32},"2023-07-17",{"date":223,"type":21},"2023-07-30",{"date":225,"type":21},"2026-12-31",{"name":227,"class":228},"Asia Cell Therapeutics (Shanghai) Co., Ltd.","INDUSTRY"]