[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603055":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":20,"responsibleParty":35,"collaborators":37,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":20,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":20,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":20},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Safety and feasibility of ucMSCs therapy in non-viral ACLF (Phase-1)","EXPERIMENTAL","ACLF patients as per the definition of Asian Pacific association for the study of the liver (APASL) will be enrolled for safety and feasibility study of umbilical cord mesenchymal stem cells (ucMSCs). To test the safety and tolerability of ucMSC 1 million\u002Fkg will be given intra-venously once a week for 4 week in 10 ACLF patients. 250 ml normal saline will be infused 30 minutes prior to ucMSCs infusion. The fresh ucMSCs will be taken from ILBS cGMP facility and will 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.",[13],"Drug: umbilical cord Mesenchymal Stem Cell",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","umbilical cord Mesenchymal Stem Cell","To test the safety and tolerability of ucMSC 1 million\u002Fkg will be given intra-venously once a week for 4 week in 10 ACLF patients. 250 ml normal saline will be infused 30 minutes prior to ucMSCs infusion. The fresh ucMSCs will be taken from ILBS cGMP facility and will be infused through IV canula peripherally over 30 minutes followed by a further 250 ml normal saline over 20-30 minutes.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Dr. Shiv Kumar Sarin, DM","Institute of Liver & Biliary Sciences","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Dr. Anupam Kumar, PhD","CONTACT","01146300000","dr.anupamkumar.ilbs@gmail.com",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},"Fagun Sharma, M.Sc","fagun.30sharma@gmail.com",{"type":36,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[38],{"name":39,"class":40},"Indian Council of Medical Research","OTHER_GOV","100603055","phase-1-national-collaborative-centre-for-hepatic-regenerative-medicine-nc-chrm-phase-i-study-on-safety-and-efficacy-of-mesenchymal-stem-cell-msc-therapy-in-non-viral-acute-on-chronic-liver-failure-aclf-100603055",false,"NCT07131540","National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Phase I Study on Safety and Efficacy of Mesenchymal Stem-Cell (MSC) Therapy in Non-Viral Acute-on-Chronic Liver Failure (ACLF)","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-I Clinical Study","NC-CHRM","Inclusion Criteria:\n\n* ACLF patients with Model for End-Stage Liver Disease (MELD) \\>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 (DIC)\n* Patients improving on standard medical treatment\n* Patients on immunosuppressive medications\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":53,"type":54},10,"ESTIMATED","INTERVENTIONAL",[57],"PHASE1","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 MSCs, shows promise but lacks validation, particularly for non-viral Acute on Chronic Liver Failure (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.",[60],"Acute-On-Chronic Liver Failure",[62,63,64],"ACLF","MSC","Liver failure","NOT_YET_RECRUITING","2025-08-21",{"date":68,"type":69},"2025-08-28","ACTUAL",{"date":71,"type":54},"2026-01",{"date":73,"type":54},"2031-12",{"name":5,"class":6}]