Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-04 @ 8:54 PM
Study NCT ID:
NCT02619734
Status:
UNKNOWN
Last Update Posted:
2015-12-02
First Post:
2015-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2015-11-30', 'studyFirstSubmitQcDate': '2015-12-01', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events', 'timeFrame': '6 months', 'description': 'Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events'}, {'measure': 'Change in Leg Ulcer', 'timeFrame': '6 months to one year', 'description': 'Rate and extent of leg ulcer wound healing as measured by change in wound surface area Ulcer diameter will be recorded'}], 'secondaryOutcomes': [{'measure': 'Numeric pain intensity scale (0-10)', 'timeFrame': '6 months to one year', 'description': 'Change in Sickle Cell Disease leg ulcer wound pain scores as measured by a 10-point scale (analogic visual scale) and relative to non-wound site pain scores'}, {'measure': 'Ulcer Healing', 'timeFrame': '6 months to one year', 'description': 'Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area Ulcer diameter will be recorded'}, {'measure': 'Quality of Life', 'timeFrame': '6 months to one year', 'description': 'Change in quality of life as well as other indicators of patient comfort and well-being'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cell Therapy', 'Sickle cell disease', 'Autologous implantation', 'Mesenchymal stromal cell', 'Edothelial Progenitor cell'], 'conditions': ['Chronic Leg Ulcer', 'Sickle Cell Disease']}, 'referencesModule': {'references': [{'pmid': '26021713', 'type': 'BACKGROUND', 'citation': 'Daltro GC, Fortuna V, de Souza ES, Salles MM, Carreira AC, Meyer R, Freire SM, Borojevic R. Efficacy of autologous stem cell-based therapy for osteonecrosis of the femoral head in sickle cell disease: a five-year follow-up study. Stem Cell Res Ther. 2015 May 29;6(1):110. doi: 10.1186/s13287-015-0105-2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell disease.', 'detailedDescription': 'Implantation of bone marrow mononuclear cells, including endothelial progenitor cells and mesenchymal stromal cells, into leg ulcers has been shown to improve wound healing.\n\nIn the present study the safety and efficacy of autologous bone marrow mononuclear cells implantation will be investigated in patients with chronic leg ulcers. Forty cases will be enrolled. Improvement in the pain, rate and extent of leg ulcer wound healing as measured by change in wound surface area will be evaluated until one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable sickle cell disease patients\n* Patient hospitalized into the dermatology unit\n* Patient with an evolutive leg ulcer since more than 1 year\n* No infection at the time of surgery\n* Patient competent to give informed consent\n\nExclusion Criteria:\n\n* Patients with a history of corticosteroids or on active therapy\n* infection at the limb affected by ulcer\n* Recurrent painful crises,\n* Immunosuppressive drug therapy,\n* Pregnancy,\n* Presence of neoplastic disease or any other clinical concurrent condition other than sickle cell disease that predisposed them to the development of leg ulcer'}, 'identificationModule': {'nctId': 'NCT02619734', 'briefTitle': 'Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Bahia'}, 'officialTitle': 'Efficacy and Safety of Autologous Bone Marrow Stem Cells Infusion for Treatment of Chronic Leg Ulcer in Sickle Cell Disease Patients', 'orgStudyIdInfo': {'id': '11738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Conventional treatment established by the good clinical practice Patients received standard local care dressing method (compresses) to heal leg ulcers'}, {'type': 'EXPERIMENTAL', 'label': 'Stem Cell Injection', 'description': 'Intramuscular implantation of Autologous bone marrow-derived mononuclear cells', 'interventionNames': ['Biological: Infusion of Autologous Bone Marrow Mononuclear Cells']}], 'interventions': [{'name': 'Infusion of Autologous Bone Marrow Mononuclear Cells', 'type': 'BIOLOGICAL', 'description': 'Autologous bone marrow-derived mononuclear cells will be administered by intramuscular injection into and around the leg ulcer. The number of injected cells will be from 5x108 to 1x109 total number of cells on Study Day 1.', 'armGroupLabels': ['Stem Cell Injection']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'José Valber Meneses, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of Bahia'}, {'name': 'Gildasio Daltro, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of Bahia'}, {'name': 'Vitor A Fortuna, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Bahia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Bahia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oswaldo Cruz Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Vitor Fortuna', 'investigatorAffiliation': 'Federal University of Bahia'}}}}