Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-03 @ 11:31 PM
Study NCT ID:
NCT03826433
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Validity evaluation by detection of the coagulation function of participants', 'timeFrame': '12 month', 'description': 'After finish the mesenchymal stem cell treatment, observe the change of Prothrombin Time and International Normalized Ratio (PT/INR) in baseline outcome measures.\n\nThe time is around 12-13 seconds, the INR in absence of anticoagulation therapy is 0.8-1.2.'}, {'measure': 'Imaging examination', 'timeFrame': '12 month', 'description': 'After finish the mesenchymal stem cell treatment, observe the Computed Tomography (CT).'}, {'measure': 'Imaging examination', 'timeFrame': '12 month', 'description': 'Fibro-Touch examination'}, {'measure': 'Safety evaluation by detecting adverse events and serious adverse events', 'timeFrame': '12 month', 'description': 'To evaluate the changes of safety indexes before and after mesenchymal stem cell treatment'}], 'primaryOutcomes': [{'measure': 'Validity evaluation by detection of the Model for end-stage Liver Disease score of participants', 'timeFrame': '12 month', 'description': 'After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures.\n\n40 or more - 71.3% observed mortality 30-39 - 52.6% observed mortality 20-29 - 19.6% observed mortality 10-19 - 6.0% observed mortality \\<9 - 1.9% observed mortality'}], 'secondaryOutcomes': [{'measure': 'Safety evaluation by detecting Blood routine', 'timeFrame': '12 month', 'description': 'To calculate the number of hemocyte and related protein (e.g. erythrocyte, lymphocyte, and hemoglobin) after mesenchymal stem cell treatment'}, {'measure': 'Validity evaluation by detection of the child-pugh of participants', 'timeFrame': '12 month', 'description': 'After finish the mesenchymal stem cell treatment, observe the change in baseline outcome measures.\n\nPoints Class One-year survival Two-year survival 5-6 A 100% 85% 7-9 B 80% 60% 10-15 C 45% 35%'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B Cirrhosis, mesenchymal stem cell'], 'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': '1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.\n2. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat.\n3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.', 'detailedDescription': 'This experimental use umbilical cord mesenchymal stem cells in treatment of decompensated hepatitis B cirrhosis to evaluate its safety and efficacy,\n\nThis experimental is mainly aimed at people aged 18-60 years old, regardless of gender and with body mass index (BMI) between 19-25kg/m2 (including boundary value). It was decided into treatment group and control group to evaluate the effectiveness and safety of mesenchymal stem cells by peripheral intravenous injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg/m2, including boundary value;\n* The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver function grade was child-pugh B or child-pugh C, with a score range of 7-12 points, and Model for End-Stage Liver Disease score≤21 points.\n* Have not received stem cell therapy in the recent 6 months;\n* Subjects will be able to sign the informed consent in accordance with the study procedures and instructions.\n\nExclusion Criteria:\n\n* Insufficiency of vital organs, such as heart, kidney and lung;\n* End-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites, etc.\n* Concomitant peritonitis, pneumonia, or other types of infection not under control;\n* Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine;\n* Positive serum HIV antibody and syphilis antibody;\n* Alpha fetoprotein\\>400ng/mL with primary liver cancer or without imaging evidence;\n* Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus infection, or other factors except chronic hepatitis B virus infection ;\n* Patients with severe mental illness and cognitive impairment;'}, 'identificationModule': {'nctId': 'NCT03826433', 'briefTitle': 'hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sclnow Biotechnology Co., Ltd.'}, 'officialTitle': 'Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis', 'orgStudyIdInfo': {'id': 'SCLnow-XY-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Mesenchymal Stem Cells : through peripheral intravenous slowly, every time 6\\*10\\^7 (30ml) Other medication of Treatment Group: before the30min of first time to inject stem cells, Intravenous methylprednisone 20mg. All patients require oral nucleoside drugs resistant hepatitis B virus treatment.Use stem cell therapy, by Peripheral iv, 6 \\* 10 \\^ 7 (30 ml)', 'interventionNames': ['Biological: Peripheral iv']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control Group: Using basic contrast .'}], 'interventions': [{'name': 'Peripheral iv', 'type': 'BIOLOGICAL', 'description': '6\\*10\\^7 cells', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ShaLing Li, doctor', 'role': 'CONTACT', 'phone': '8613975186154'}, {'name': 'Xuegong Fan, doctor', 'role': 'CONTACT', 'email': 'xgfan@hotmail.com', 'phone': '86731-84327392'}], 'facility': 'Xiangya Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Lei Guo, doctor', 'role': 'CONTACT', 'email': 'georgeguo@sclnow.com', 'phone': '861064368977'}, {'name': 'Xuegong Fan, doctor', 'role': 'CONTACT', 'email': 'xgfan@hotmail.com', 'phone': '86731-84327392'}], 'overallOfficials': [{'name': 'Xuegong Fan, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xiangya Hospital of Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sclnow Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}