Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT03863002
Status:
UNKNOWN
Last Update Posted:
2019-03-20
First Post:
2019-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}], 'ancestors': [{'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'both participants and the study team are unblinded to the treatment allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2019-02-18', 'studyFirstSubmitQcDate': '2019-03-02', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival rate', 'timeFrame': '72 weeks after treatment', 'description': 'Number of participants alive'}], 'secondaryOutcomes': [{'measure': 'Adverse reactions', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Number of participants with adverse reactions (e.g. fever, rash, and diarrhea )'}, {'measure': 'White blood cell', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Change of white blood cell count'}, {'measure': 'Platelet', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Change of platelet count'}, {'measure': 'Hemoglobin', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Change of hemoglobin level'}, {'measure': 'Creatinine', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Change of creatinine level as a surrogate marker of liver function'}, {'measure': 'ALT', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Change of alanine aminotransferase (ALT) level as a marker of liver function'}, {'measure': 'ALB', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Change of albumin (ALB) level as a maker of liver function'}, {'measure': 'TBil', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Change of total Bilirubin (TBil) level as a marker of liver function'}, {'measure': 'INRs', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Change of international normalized ratio (INRs) level as a marker of liver function'}, {'measure': 'AFP', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Change of alpha fetoprotein (AFP) level as a marker of liver function'}, {'measure': 'MELD scores', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Model for End-Stage Liver Disease (MELD) score for assessing the severity of chronic liver disease is measured as absolute change to baseline score'}, {'measure': 'Tumor formation', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Number of participants with hepatocellular carcinoma or extrahepatic malignant tumors'}, {'measure': 'Liver failure-associated serious complications', 'timeFrame': 'Week 1, 2, 4, 8, 12, 24, 36, 48', 'description': 'Number of participants with liver failure-associated serious complications, such as infections, encephalopathy, gastrointestinal bleeding and HRS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mesenchymal stem cell'], 'conditions': ['Liver Failure, Acute on Chronic']}, 'descriptionModule': {'briefSummary': 'Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure', 'detailedDescription': 'Acute-on-chronic liver failure (ACLF) which occurs in patients with chronic liver disease, is a serious live-threatening disease. Currently, the clinical management, such as liver protection, anti-virus medicine, and artificial liver support, has not significantly improve the outcomes, the mortality still remains over 50%. Liver transplantation is the only effective treatment of ACLF, but this therapy is limited by the shortage of donor organs, potential surgical complications, immunological rejection and high medical costs. Mesenchymal stem cell (MSC) is one of adult stem cells, which has been suggested to play a role in amelioration of liver disease, such as: trans-differentiation of MSCs into hepatocytes, immunomodulation, inhibition of fibrosis development, protective effects on hepatic cell and restoration of hepatic cell proliferation capacity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent\n2. Meeting the definition of ACLF: patients with previously diagnosed or undiagnosed chronic liver disease acute decompensated within 4 weeks; significant GI symptom as such fatigue, jaundice; serum total bilirubin \\[TBil\\] ≥10 X the upper limit of normal; coagulopathy (international normalized ratio \\[INR\\] ≥1.5 or prothrombin activity \\[PTA\\] \\<40%); complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination.\n3. Model for End-Stage Liver Disease (MELD) scores ranging 17-30, (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643);\n4. Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases\n5. Body weight ≥50kg\n\nExclusion Criteria:\n\n1. Serious complications in the previous 2 months (e.g., gastrointestinal bleeding: hemoglobin below 90g/L, serious infection such as sepsis, ascites ultrafiltration, and/or dialysis);\n2. Malignant jaundice induced by obstructive jaundice or hemolytic jaundice;\n3. Hepatocellular carcinoma (HCC) diagnosed by radiologic imaging and/or alpha fetoprotein (AFP);\n4. Tumor diagnosed by ultrasound, CT, MR examination;\n5. Moderate or severe chronic heart failure (NYHA III-IV), renal replacement therapy, severe chronic pulmonary disease (GOLD III-IV)\n6. Extrahepatic cholestasis\n7. Hepatic, portal and splenic vein thrombosis diagnosed by doppler ultrasound\n8. Artificial liver support\n9. Previous liver transplantation\n10. Drug abuse in the past 5 years;\n11. Mental disorders and/or has a family history of mental disorder.\n12. HIV infection\n13. Pregnant or breast-feeding females\n14. Highly allergic\n15. Patients can not cooperate or mobility\n16. Enrolled in other clinical trials with 3 months\n17. Patients who can not provide prior informed consent or refusal to participate'}, 'identificationModule': {'nctId': 'NCT03863002', 'briefTitle': 'Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tianjin Weikai Bioeng., Ltd.'}, 'officialTitle': 'Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure', 'orgStudyIdInfo': {'id': 'Tianjin Weikai Bioeng., Ltd'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Medical Treatment', 'description': 'Standard Medical Treatment (SMT): All patients received SMT, including nutritional supplementation; administration of human serum albumin (serum albumin \\<30 g/L), fresh frozen plasma (200-400 mL/day until the INR was \\<1.5), S-adenosylmethionine (1.0 g/day); or anti-virus treatment for hepatic viruses-related cases, and appropriate treatment for complications such as infections (including of the respiratory tract, urinary tract, biliary tract, and digestive tract and spontaneous peritonitis), encephalopathy, gastrointestinal bleeding, and hepatorenal syndrome \\[HRS\\]).'}, {'type': 'EXPERIMENTAL', 'label': 'Mesenchymal Stem Cell', 'description': 'Mesenchymal Stem Cell (MSC): The MSC group received infusions of 1.0 to 10x10\\^5cells/kg MSCs through the peripheral vein once a week for 4 weeks, in addition to SMT.', 'interventionNames': ['Biological: Mesenchymal Stem Cell']}], 'interventions': [{'name': 'Mesenchymal Stem Cell', 'type': 'BIOLOGICAL', 'description': 'Mesenchymal stem cell transplantation via peripheral vein: 1.0-10x10\\^5 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2, 3 weeks', 'armGroupLabels': ['Mesenchymal Stem Cell']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'contacts': [{'name': 'Xiuli Cong, MD, PhD', 'role': 'CONTACT', 'email': 'cong_xiuli@163.com', 'phone': '+86 18512507567'}], 'facility': 'Tianjin Weikai Bioeng., Ltd.', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Xiuli Cong, MD, PhD', 'role': 'CONTACT', 'email': 'cong_xiuli@163.com', 'phone': '+86 18512507567'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Weikai Bioeng., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tianjin Nankai Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}