Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT00713934
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
2008-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow Stem Cells in Cirrhosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'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', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-01', 'studyFirstSubmitDate': '2008-07-09', 'studyFirstSubmitQcDate': '2008-07-11', 'lastUpdatePostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver function test', 'timeFrame': '6 months'}, {'measure': 'MELD score', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Cirrhosis mortality', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Autologous Bone marrow stem cells', 'Cirrhosis'], 'conditions': ['Stem Cell Transplantation', 'Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '21194255', 'type': 'DERIVED', 'citation': 'Nikeghbalian S, Pournasr B, Aghdami N, Rasekhi A, Geramizadeh B, Hosseini Asl SM, Ramzi M, Kakaei F, Namiri M, Malekzadeh R, Vosough Dizaj A, Malek-Hosseini SA, Baharvand H. Autologous transplantation of bone marrow-derived mononuclear and CD133(+) cells in patients with decompensated cirrhosis. Arch Iran Med. 2011 Jan;14(1):12-7.'}], 'seeAlsoLinks': [{'url': 'http://www.royaninstitute.org', 'label': 'Royan Institute'}]}, 'descriptionModule': {'briefSummary': "Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it's serious problems. The potential for stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study we will evaluate safety and feasibility of autologous bone marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation through the portal vein in patients with decompensate cirrhosis.", 'detailedDescription': 'BM (200 ml) will be harvested from the iliac crest according to standard procedures under general anesthesia and is collected in plastic bags containing anti coagulant. After precipitation of red blood cells, Low density mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For CD133+ cells separation the CliniMACS instrument will be used. Cells are injected via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 4 weeks, and laboratory data are analyzed for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver biopsy showing histological Cirrhosis, grade B or C (Child-Pugh score)\n* Alkaline phosphatase between 2 X to 3X normal value\n* liver Cirrhosis in Sonography study\n* Incomplete response to UDCA after 6 months of treatment.\n* Negative pregnancy test (female patients in fertile age)\n* written consent\n\nExclusion Criteria:\n\n* Presence of active hepatic encephalopathy\n* Refractory ascites\n* Evidences of active autoimmune liver disease (e.g. gamma globulin of more than 2 times of upper limit of normal, and ALT \\> 3 times normal in patients with autoimmune hepatitis)\n* Hepatocellular carcinoma or other malignancies\n* sepsis\n* Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)\n* HIV, HBV or HCV infection\n* Cardiac, renal or respiratory failure\n* Active thrombosis of the portal or hepatic veins\n* INR\\>2'}, 'identificationModule': {'nctId': 'NCT00713934', 'briefTitle': 'Autologous Bone Marrow Stem Cells in Cirrhosis Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Autologous Transplantation of Bone Marrow Derived CD 133 Positive Stem Cell and Mono Nuclear Cell (MNC) Transplantation in Patients With Decompensate Cirrhosis: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Liver-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: CD133']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Biological: BM-MNC']}], 'interventions': [{'name': 'CD133', 'type': 'BIOLOGICAL', 'description': 'portal vein infusion of CD133+ cells', 'armGroupLabels': ['1']}, {'name': 'BM-MNC', 'type': 'BIOLOGICAL', 'description': 'portal vein infusion of BM-MNC', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Liver Transplant Research Center', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}, {'zip': '1665659911', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Royan Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Hamid Gorabi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Royan institute, Tehran, Iran'}, {'name': 'Malekhosseini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Liver Transplantation Research Center, Shiraz, Iran'}, {'name': 'Hossein Baharvand, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royan institute, Tehran, Iran'}, {'name': 'Saman Nikeghbal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liver Transplantation Research Center, Shiraz, Iran'}, {'name': 'Nasser Aghdami, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Royan institute, Tehran, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Small Business Developing Center', 'class': 'UNKNOWN'}, {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}