Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-11 @ 10:28 PM
Study NCT ID:
NCT00615394
Status:
COMPLETED
Last Update Posted:
2008-02-14
First Post:
2008-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-01', 'studyFirstSubmitDate': '2008-02-01', 'studyFirstSubmitQcDate': '2008-02-01', 'lastUpdatePostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety: morbidity/mortality', 'timeFrame': 'eighteen months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiomyopathy, stem cell, cardiac failure'], 'conditions': ['Dilated Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '18553028', 'type': 'DERIVED', 'citation': "Kalil RA, Ott D, Sant'Anna R, Dias E, Marques-Pereira JP, Delgado-Canedo A, Nardi NB, Sant'Anna JR, Prates PR, Nesralla I. Autologous transplantation of bone marrow mononuclear stem cells by mini-thoracotomy in dilated cardiomyopathy: technique and early results. Sao Paulo Med J. 2008 Mar 6;126(2):75-81. doi: 10.1590/s1516-31802008000200003."}]}, 'descriptionModule': {'briefSummary': 'Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy\n* left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram\n* age below 60 years\n* absence of neoplasm\n* absence of hematologic disease or systemic disease\n* no previous cardiac intervention\n\nExclusion Criteria:\n\n* episodes of tachycardia or ventricular fibrillation\n* severe or moderated mitral insufficiency\n* any other valvulopathies'}, 'identificationModule': {'nctId': 'NCT00615394', 'acronym': 'STEMDILCARD', 'briefTitle': 'Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiologia do Rio Grande do Sul'}, 'officialTitle': 'Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results', 'orgStudyIdInfo': {'id': 'UP3549/04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intramyocardial bone marrow stem cells implantation', 'type': 'PROCEDURE', 'description': 'Patients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '906200001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Instituto de Cardiologia do Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Cardiologia do Rio Grande do Sul', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil', 'class': 'OTHER'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldOrganization': 'Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia'}}}}