Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 9:38 PM
Study NCT ID:
NCT01499459
Status:
UNKNOWN
Last Update Posted:
2012-03-22
First Post:
2011-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-09-09', 'releaseDate': '2013-07-03'}, {'resetDate': '2014-02-15', 'releaseDate': '2014-01-05'}, {'resetDate': '2014-06-05', 'releaseDate': '2014-05-07'}, {'resetDate': '2014-11-20', 'releaseDate': '2014-11-14'}, {'resetDate': '2015-01-06', 'releaseDate': '2014-12-19'}], 'estimatedResultsFirstSubmitDate': '2013-07-03'}}, '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': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-20', 'studyFirstSubmitDate': '2011-12-14', 'studyFirstSubmitQcDate': '2011-12-22', 'lastUpdatePostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical improvement', 'timeFrame': 'clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation', 'description': 'biochemical and hematologic parameters'}], 'secondaryOutcomes': [{'measure': 'liver regeneration', 'timeFrame': '6.th month after MSC transplantation', 'description': 'histopathologic assesments comparing before and at 6th month liver biopsies'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['liver cirrhosis', 'autologous mesenchymal stem cell transplantation'], 'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': "This study is aiming to investigate the efficacy of autologous mesenchymal stem cell (MSC) transplantation in 25 randomized patients with liver cirrhosis autologous mesenchymal stem cell will be derived from patients' bone marrows and will be infused via peripheral vein. Liver biopsies will be performed in every patient in the beginning and at 6th month."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* radiological, clinical and histopathological diagnosis of liver cirrhosis\n* absence of hepatocellular carcinoma or any malignancies\n* no psychiatric disorder\n* no serous cardiovascular and pulmonary comorbidities\n* serum total bilirubin levels less than 5 mg/dL\n* platelet counts more than 30.000 mm3\n* more than one year follow up period after initiation of antiviral drugs\n\nExclusion Criteria:\n\n* alcohol intake in last one year\n* initiation of antiviral medication in last one year\n* systemic diseases'}, 'identificationModule': {'nctId': 'NCT01499459', 'briefTitle': 'Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}, 'officialTitle': 'Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis', 'orgStudyIdInfo': {'id': '11111111'}, 'secondaryIdInfos': [{'id': '1111111', 'type': 'OTHER', 'domain': 'Gulhane School of Medicine'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'autologous mesenchymal stem cell transplantation', 'interventionNames': ['Genetic: autologous mesenchymal stem cell transplantation']}], 'interventions': [{'name': 'autologous mesenchymal stem cell transplantation', 'type': 'GENETIC', 'description': 'Every patient is given 1x106 MSCs per kg infused via peripheral vein.', 'armGroupLabels': ['autologous mesenchymal stem cell transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06018', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gulhane Military Medical Academy Department of Gastroenterology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'murat kantarcioglu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gulhane Military Medical Academy', 'investigatorFullName': 'Murat Kantarcioglu', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-07-03', 'type': 'RELEASE'}, {'date': '2013-09-09', 'type': 'RESET'}, {'date': '2014-01-05', 'type': 'RELEASE'}, {'date': '2014-02-15', 'type': 'RESET'}, {'date': '2014-05-07', 'type': 'RELEASE'}, {'date': '2014-06-05', 'type': 'RESET'}, {'date': '2014-11-14', 'type': 'RELEASE'}, {'date': '2014-11-20', 'type': 'RESET'}, {'date': '2014-12-19', 'type': 'RELEASE'}, {'date': '2015-01-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Murat Kantarcioglu, Gulhane Military Medical Academy, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}}}}