Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-30 @ 11:54 PM
Study NCT ID:
NCT01342250
Status:
COMPLETED
Last Update Posted:
2011-10-14
First Post:
2011-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver 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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-13', 'studyFirstSubmitDate': '2011-04-21', 'studyFirstSubmitQcDate': '2011-04-25', 'lastUpdatePostDateStruct': {'date': '2011-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '1 year after treatment'}], 'secondaryOutcomes': [{'measure': 'Liver function improvement', 'timeFrame': '1 year after treatment'}, {'measure': 'The size of liver and the width of portal venous', 'timeFrame': '1 year after treatment'}, {'measure': 'Incidence of hepatocellular carcinoma within 1 year', 'timeFrame': '1 year after treatment'}, {'measure': 'Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL)', 'timeFrame': '1 year after treatment'}, {'measure': 'The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al )', 'timeFrame': '1 year after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Decompensated Liver Cirrhosis', 'Umbilical Cord Mesenchymal Stem Cells'], 'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued experimental liver failure and contributed to liver regeneration, which suggest the novel and promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver cirrhosis will be evaluated.', 'detailedDescription': 'To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent.\n* Aged 18-70 years.\n* Decompensated liver cirrhosis, Child-Pugh B/C (7-12 points); or Meld score≦21.\n* Expecting lifetime is over 2 months.\n* Hepatitis B decompensated liver cirrhosis patients need antiviral therapy.\n\nExclusion Criteria:\n\n* Severe drug allergic history or anaphylaxis.\n* Severe problems in other vital organs(e.g. the heart, renal or lungs)\n* Severe problems in psychiatric disease,such as Schizophrenia,et al\n* Severe bacteria infection.\n* Malignancies.\n* Alcoholism or drug abuse.\n* Plan to have liver transplantation in 3 months.\n* Pregnancy\n* Candidates who are participating in other study.'}, 'identificationModule': {'nctId': 'NCT01342250', 'briefTitle': 'Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen Beike Bio-Technology Co., Ltd.'}, 'officialTitle': 'Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis', 'orgStudyIdInfo': {'id': 'BKCR-LD-1.0(2010)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional plus hUC-MSCs treatment (low dose)', 'interventionNames': ['Biological: conventional therapy plus low dose hUC-MSCs treatment']}, {'type': 'EXPERIMENTAL', 'label': 'conventional therapy plus hUC-MSCs treatment （medium dose）', 'interventionNames': ['Biological: conventional therapy plus medium dose hUC-MSCs treatment']}, {'type': 'EXPERIMENTAL', 'label': 'conventional therapy plus hUC-MSCs treatment （high dose）', 'interventionNames': ['Biological: conventional therapy plus high dose hUC-MSCs treatment']}], 'interventions': [{'name': 'conventional therapy plus low dose hUC-MSCs treatment', 'type': 'BIOLOGICAL', 'description': 'patients will receive the conventional therapy plus low dose hUC-MSCs treatment', 'armGroupLabels': ['Conventional plus hUC-MSCs treatment (low dose)']}, {'name': 'conventional therapy plus medium dose hUC-MSCs treatment', 'type': 'BIOLOGICAL', 'description': 'patients will receive conventional therapy plus medium dose hUC-MSCs treatment', 'armGroupLabels': ['conventional therapy plus hUC-MSCs treatment （medium dose）']}, {'name': 'conventional therapy plus high dose hUC-MSCs treatment', 'type': 'BIOLOGICAL', 'description': 'patients will receive conventional therapy plus high dose hUC-MSCs treatment', 'armGroupLabels': ['conventional therapy plus hUC-MSCs treatment （high dose）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200235', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Chengwei Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'No.85 Hospital, Changning, Shanghai, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Beike Bio-Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'No.85 Hospital, Changning, Shanghai, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}