Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT01309594
Status:
UNKNOWN
Last Update Posted:
2014-09-25
First Post:
2011-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV Liver Regeneration Project for HIV Patients With Cirrhosis by Autologous Bone Marrow Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}], 'ancestors': [{'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-24', 'studyFirstSubmitDate': '2011-03-03', 'studyFirstSubmitQcDate': '2011-03-03', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-transplantation prognosis for cirrhosis', 'timeFrame': '24 weeks', 'description': 'Evaluate statistical significance between pre-transplantation and 24 weeks after in:\n\n* Child-Pugh score\n* albumin\n* serum fibrosis markers\n* Transient Elastography (TM)\n* ascites imagery\n* SF-36v2(TM) Health Survey.\n\nBecause advanced liver cirrhosis is a progressive condition itself, treatment efficacy is defined by "improvement" and "no change" in the indicators listed.'}], 'secondaryOutcomes': [{'measure': 'Duration of the treatment efficacy', 'timeFrame': 'After 24 weeks up to 48 weeks', 'description': 'Using the same evaluation modules as of the primary outcomes, investigate and assess the autologous bone marrow transplantation effectivity chronologically after the primal 24 weeks up to 48 weeks to evaluate the duration of the treatment efficacy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV Infection', 'AIDS', 'Cirrhosis']}, 'descriptionModule': {'briefSummary': 'An international investigation to evaluate if, and if so how long, autologous bone marrow hematopoietic stem cell transplantation can safely restore liver functions for HIV infected patients who have decompensated liver cirrhosis.', 'detailedDescription': 'An international investigation to evaluate if, and if so how long, autologous bone marrow (ABM) hematopoietic stem cell transplantation (HSCT) can safely restore liver functions for HIV infected patients who have decompensated liver cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine who meet all criteria following:\n\n* have cirrhosis with 7 or higher Child-Pugh Score in Child-Pugh Score B\n* able to consent and willing to participate in the study\n* under good control for HIV infection\n\nExclusion Criteria: Cases applicable to ANY condition of the following:\n\n* Hepatocellular carcinoma (HCC), except for cases having been completely treated without history of recurrence\n* Malignant tumors other than HCC\n* Alcoholic liver disease (ALD)\n* Hemoglobin under 8g/dL or Platelets under 20/ml at the registration\n* Esophageal or gastric varices with a risk of bursting, except for cases with only cured history of such conditions\n* Cases that cannot obtain the informed consent to autologous blood transfusion\n* Pregnancy\n* Renal dysfunction with 2mg/dL or higher serum creatinine\n* Performance Status 3 or 4 (assessment excludes hemophilic arthritis related daily life limitations)\n* Cases not fit for general anesthesia\n* Other conditions considered not suitable for the study by doctors'}, 'identificationModule': {'nctId': 'NCT01309594', 'acronym': 'HIV-ABMi', 'briefTitle': 'HIV Liver Regeneration Project for HIV Patients With Cirrhosis by Autologous Bone Marrow Transplantation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Center for Global Health and Medicine, Japan'}, 'officialTitle': 'A Safety and Efficacy Study of Autologous Bone Marrow Cell Infusion Therapy in HIV Infected Patients With Advanced Liver Cirrhosis', 'orgStudyIdInfo': {'id': 'FWA00005823-AMBi2011'}, 'secondaryIdInfos': [{'id': 'UMIN000005174', 'type': 'OTHER', 'domain': 'University Hospital Medical Information Network (UMIN)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hematopoietic stem cell transplantation', 'description': 'Extraction of bone marrow cells from HIV positive patients with advanced liver cirrhosis and transplant their bone marrow back into the patients', 'interventionNames': ['Procedure: Hematopoietic stem cell transplantation']}], 'interventions': [{'name': 'Hematopoietic stem cell transplantation', 'type': 'PROCEDURE', 'otherNames': ['Autologous bone marrow cell infusion therapy (ABMi)'], 'description': "Harvest and apheresis of bone marrow cells from HIV infected patients with cirrhosis under general anesthesia, using bone marrow collection system and transplanting the patients' hematopoietic stem cells back to the patients", 'armGroupLabels': ['Hematopoietic stem cell transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1628655', 'city': 'Shinjuku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Center for Global Health and Medicine', 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}], 'overallOfficials': [{'name': 'Shinichi Oka, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center for Global Health and Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Global Health and Medicine, Japan', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministry of Health, Labour and Welfare, Japan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}