Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-04 @ 12:59 AM
Study NCT ID:
NCT02652351
Status:
UNKNOWN
Last Update Posted:
2016-05-23
First Post:
2016-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-20', 'studyFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2016-01-07', 'lastUpdatePostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of adverse events', 'timeFrame': '12 months', 'description': 'According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)'}], 'secondaryOutcomes': [{'measure': 'Hepatic function', 'timeFrame': '1, 3 ,6 and 12 months', 'description': 'Include AST, ALT, T-Bil and A/G.'}, {'measure': 'Liver fibrosis index', 'timeFrame': '1, 3 ,6 and 12 months', 'description': 'The level of Hyaluronidase,Laminin,Procollagen Ⅲ and Collagen Type IV in serum.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stem cell', 'Human Umbilical Cord Mesenchymal Stem Cell', 'Mesenchymal Stem Cell', 'Hepatic Cirrhosis'], 'conditions': ['Hepatic Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.', 'detailedDescription': 'Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Hepatic Cirrhosis.\n\nTo investigate the effects of hUC-MSC treatment for Hepatic Cirrhosis, 20 patients with Hepatic Cirrhosis will be enrolled and receive 4 times of hUC-MSC transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient who have signed the informed consent document;\n* Clinical, radiological, or biochemical evidence of liver cirrhosis.\n\nExclusion Criteria:\n\n* Pregnant women or lactating mothers;\n* Patients who have received any anti-inflammatory drugs including herb-drug within 14 days;\n* Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment;\n* Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;\n* Abnormal blood coagulation, combine other tumor or special condition;\n* Patients who had participated in other clinical trials within three months prior to this study.'}, 'identificationModule': {'nctId': 'NCT02652351', 'briefTitle': 'Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen Hornetcorn Bio-technology Company, LTD'}, 'officialTitle': 'Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis', 'orgStudyIdInfo': {'id': 'HYK-hepatic cirrhosis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hUC-MSC treatment', 'description': 'Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.', 'interventionNames': ['Biological: Human umbilical cord mesenchymal stem cells']}], 'interventions': [{'name': 'Human umbilical cord mesenchymal stem cells', 'type': 'BIOLOGICAL', 'otherNames': ['hUC-MSC'], 'description': 'A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion or Hepatic artery intervention, and repeated every week for four times.', 'armGroupLabels': ['hUC-MSC treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '431224', 'city': 'Hengyang', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gang Chen, Professor', 'role': 'CONTACT', 'email': 'Chengang@126.com', 'phone': '0734-8899939', 'phoneExt': '621'}], 'facility': 'The second Affiliated Hospital of University of Soth China', 'geoPoint': {'lat': 26.88946, 'lon': 112.61888}}], 'centralContacts': [{'name': 'Jin S Cao, lab master', 'role': 'CONTACT', 'email': 'CaoJS@hornetcon.com', 'phone': '+86 0734-53137955'}], 'overallOfficials': [{'name': 'Gang Chen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The second Affiliated Hospital of University of Soth China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Hornetcorn Bio-technology Company, LTD', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Second Hospital University of South China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}