[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598732":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":86,"collaborators":88,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":27,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":116,"whyStopped":27,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Umbilical cord Mesenchymal stem cell (ucMSC) and standard medical treatment (SMT)","EXPERIMENTAL","Patient randomize for MSC therapy together with standard medical treatment, ucMSC 1 million\u002Fkg will be given once a week for 4 week . 250 ml normal saline will be infused 30 minutes prior to ucMSCs infusion. The fresh ucMSCs will then be infused through IV canula peripherally over 30 minutes followed by a further 250 ml normal saline over 20-30 minutes. A baseline early warning score (EWS) will be undertaken with continuous monitoring of pulse and with blood pressure checks every 5 minutes during the cell infusion and then every 15 minutes during the subsequent 2-hour observation period, then every hour for the remaining 10-hour observation period (minimum total of 12 hours observation) after cell infusion. All patients will receive the standard medical treatment (SMT).",[13,14],"Drug: Umbilical cord Mesenchymal stem cell","Other: Standard Medical Treatment",{"label":16,"type":17,"description":18,"interventionNames":19},"Steroid and Standard medical treatment","ACTIVE_COMPARATOR","Patients in steroid group will be given prednisolone 40 mg once daily for 7 days as inpatients. After that Lille score will be calculated on day 7. Responders (Lille score \\\u003C 0.45) will be continued on steroids for a total of 4 weeks, followed by 2 weeks of tapering before stopping the therapy. In patients who were nonresponsive to steroids (Lille score \\> 0.45) at day 7, steroids will be stopped at day 7 and will receive only SMT. Patients will be managed as per requirement with nutrition, lactulose, intravenous albumin, fluids, blood transfusion or antibiotics as required. Patients with hepatorenal syndrome will be treated with intravenous terlipressin or noradrenaline. Renal replacement therapy will be done for standard indications in patients with severe volume overload, metabolic acidosis, or hyperkalemia unresponsive to goal-directed SMT as described above. Mechanical ventilation and routine intensive care management will be done in patients with multiorgan failure.",[20,14],"Drug: Steroid",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Umbilical cord Mesenchymal stem cell","ucMSC 1 million\u002Fkg will be given once a week for 4 week . 250 ml normal saline will be infused 30 minutes prior to ucMSCs infusion. The fresh ucMSCs will then be infused through IV canula peripherally over 30 minutes followed by a further 250 ml normal saline over 20-30 minutes.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Steroid","Prednisolone 40 mg once daily for 7 days as inpatients. After that Lille score will be calculated on day 7. Responders (Lille score \\\u003C 0.45) will be continued on steroids for a total of 4 weeks, followed by 2 weeks oftapering before stopping the therapy. In patients who were non responsive to steroids (Lille score \\> 0.45) at day 7, steroids will be stopped at day 7 and will receive only SMT.",[16],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Standard Medical Treatment","All patients will receive the standard medical treatment.",[16,9],[37],{"name":38,"affiliation":39,"role":40},"Dr. Shiv Kumar Sarin, DM","Institute of Liver & Biliary Sciences","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Dr. Anupam Kumar, PhD","CONTACT","01146300000","dr.anupamkumar.ilbs@gmail.com",{"name":48,"role":44,"phone":45,"phoneExt":27,"email":49},"Fagun Sharma, M.Sc","fagun.30sharma@gmail.com",[51,66,78],{"facility":52,"status":27,"city":53,"state":27,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Postgraduate Institute of Medical Education and Research (PGIMER)","Chandigarh","160012","India","IN",{"type":58,"coordinates":59},"Point",[60,61],76.7884,30.73629,{"lat":61,"lon":60},[64],{"name":65,"role":44,"phone":27,"phoneExt":27,"email":27},"Sunil Taneja, DM",{"facility":67,"status":27,"city":68,"state":27,"zip":69,"country":55,"countryCode":56,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"All India Institutes of Medical Sciences (AIIMS)","New Delhi","110029",{"type":58,"coordinates":71},[72,73],77.2148,28.62137,{"lat":73,"lon":72},[76],{"name":77,"role":44,"phone":27,"phoneExt":27,"email":27},"Shalimar, DM",{"facility":39,"status":27,"city":68,"state":27,"zip":79,"country":55,"countryCode":56,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"110070",{"type":58,"coordinates":81},[72,73],{"lat":73,"lon":72},[84,85],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},{"name":48,"role":44,"phone":45,"phoneExt":27,"email":49},{"type":87,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[89],{"name":90,"class":91},"Indian Council of Medical Research","OTHER_GOV","100598732","phase-3-national-collaborative-centre-for-hepatic-regenerative-medicine-nc-chrm-evaluating-mesenchymal-stem-cell-msc-therapy-in-non-viral-acute-on-chronic-liver-failure-aclf-patients---phase-iii-trial-100598732",false,"NCT07075315","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Evaluating Mesenchymal Stem-Cell (MSC) Therapy in Non-viral Acute on Chronic Liver Failure (ACLF) Patients - Phase-III Trial","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): To Study the Safety and Efficacy of Mesenchymal Stem-Cell Therapy in the Management of Non-viral ACLF Patients: Phase-III Clinical Study","NC-CHRM","Inclusion Criteria:\n\n* ACLF patients with Model for End-Stage Liver Disease (MELD) score \\>18 or APASL ACLF Research Consortium (AARC) grade 2 or more with (no or single extrahepatic organ dysfunction or failure having no option of liver transplant.\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>65 yrs\n* Patients with active sepsis\n* Patients with Hepatic Venous Outflow Tract Obstruction(HVOTO) or Extrahepatic Portal Vein Obstruction (EHPVO)\n* Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy\n* Active bleed (mucosal or variceal) or severe coagulopathy (platelets \\\u003C20,000 or INR\\>4)\n* Patients with refractory shock requiring norepinephrine \\>0.5ug\u002Fkg\u002Fmin\n* Patients with severe Acute Respiratory Distress Syndrome (ARDS) with Pa02\u002FFi02 \\\u003C150\n* Patients with retroviral infections\n* Autoimmune hepatitis\n* Viral etiology of liver disease\n* Co-existent Hepatitis B, Hepatitis C, HIV\n* Chronic kidney disease\n* Multiorgan failure or Disseminated Intravascular Coagulation\n* Pregnancy or active breastfeeding\n* Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease)\n* Lack of informed consent","ALL","18 Years","65 Years",{"count":104,"type":105},100,"ESTIMATED","INTERVENTIONAL",[108],"PHASE3","Liver disease deaths are rising, but transplants remain scarce in India. With over 100,000 needed annually and only \\~2,500 performed, non-transplant options are urgently needed. Regenerative therapy, especially mesenchymal stem cells (MSCs), shows promise but lacks validation, particularly for non-viral ACLF. The proposed NC-CHRM aims to develop and validate MSC-based therapy to promote native liver regeneration and offer a safe, effective, transplant-free treatment.",[111],"Acute-On-Chronic Liver Failure",[113,114,115,98],"Acute on chronic Liver Failure","ACLF","Mesenchymal Stem Cell","NOT_YET_RECRUITING","2025-08-12",{"date":119,"type":120},"2025-08-17","ACTUAL",{"date":122,"type":105},"2028-01",{"date":124,"type":105},"2031-12",{"name":5,"class":6},3]