Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-02-20 @ 6:43 PM
Study NCT ID:
NCT01062750
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2010-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-04', 'studyFirstSubmitDate': '2010-02-03', 'studyFirstSubmitQcDate': '2010-02-03', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause harmful events', 'timeFrame': 'one month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Liver Cirrhosis'], 'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Mesenchymal stem cells have capability to differentiate into hepatocyte and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells through intrahepatic arterial catheterization.', 'detailedDescription': 'The population of the liver cirrhosis patients is enormous in Japan and the only radical treatment for them is liver transplantation: however, the number of giving donor is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as hepatocytes. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the cirrhotic patients will undergo intrahepatic arterial administration of autologous adipose tissue derived stromal cells through catheter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria defined in the implementation protocol'}, 'identificationModule': {'nctId': 'NCT01062750', 'briefTitle': 'Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells', 'organization': {'class': 'OTHER', 'fullName': 'Kanazawa University'}, 'officialTitle': 'Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells', 'orgStudyIdInfo': {'id': '1132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'adipose tissue derived stromal cells', 'interventionNames': ['Biological: adipose tissue derived stromal cells dosage']}], 'interventions': [{'name': 'adipose tissue derived stromal cells dosage', 'type': 'BIOLOGICAL', 'description': 'single administration of autologous adipose tissue derived stroma cells via intrahepatic arterial catheterization', 'armGroupLabels': ['adipose tissue derived stromal cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '920-8641', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Kanazawa University Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}], 'overallOfficials': [{'name': 'Shuichi Kaneko, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Kanazawa University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanazawa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shuichi Kaneko', 'investigatorAffiliation': 'Kanazawa University'}}}}