Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-31 @ 7:23 PM
Study NCT ID:
NCT00420134
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
2007-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Liver Function in Liver Cirrhosis Patients After Autologous Mesenchymal Stem Cell Injection:a Phase I-II Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D058625', 'term': 'End Stage Liver Disease'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-15', 'studyFirstSubmitDate': '2007-01-08', 'studyFirstSubmitQcDate': '2007-01-08', 'lastUpdatePostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver function test'}, {'measure': 'MELD score'}], 'secondaryOutcomes': [{'measure': 'Cirrhosis mortality after 6 months'}]}, 'conditionsModule': {'keywords': ['mesenchymal stem cell', 'end stage liver disease', 'Cirrhosis', 'stem cell therapy'], 'conditions': ['Liver Failure', 'Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The methods for separation of mesenchymal stem cell were established in 2001. These cells can differentiate to osteocytes, hepatocytes, chondrocytes, myocytes and etc,. In this study the investigators try to separate mesenchymal stem cell from end stage liver disease, then these cells will be differentiated to progenitor of hepatocytes, finally , the investigators injected these cells into portal vein under ultrasound guide. The investigators determine the effects of injected cells in reestablishment of liver function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* MELD score of at least 10\n* Patent portal vein on color Doppler examination of the liver\n* Normal alpha-feto protein serum levels\n* Age more than 18\n* Filling inform consent by patients and first degree family members\n\nExclusion criteria:\n\n* Any evidence of hepatocellular carcinoma on liver ultrasound studies\n* Patients want to exclude from study'}, 'identificationModule': {'nctId': 'NCT00420134', 'briefTitle': 'Improvement of Liver Function in Liver Cirrhosis Patients After Autologous Mesenchymal Stem Cell Injection:a Phase I-II Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'A Phase One/Two Clinical Trial on the Use of Autograft Mesenchymal Stem Cells Differentiated Into Progenitor of Hepatocytes for the Salvage Treatment of Patients With End-stage Liver Disease', 'orgStudyIdInfo': {'id': '348'}}, 'armsInterventionsModule': {'interventions': [{'name': 'injection of progenitor of hepatocyte drived from Mesenchymal stem cell', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1985711151', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Research Center for Gastroenterology and Liver Diseases', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'zip': '1985711151', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Research center of Gastroenterology and Liver Disease', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Mohammad Reza Zali, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Research center of Gastroenterology and Liver Disease'}, {'name': 'Pedram Kharaziha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Gastroenterology and Liver Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tarbiat Modarres University', 'class': 'OTHER'}]}}}