Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-21 @ 5:56 AM
Study NCT ID:
NCT00800657
Status:
UNKNOWN
Last Update Posted:
2011-06-23
First Post:
2008-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stem Cells and Resynchronization Cardiac
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2008-11-12', 'studyFirstSubmitQcDate': '2008-12-01', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative.', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Ejection Fraction (Echo/Sympson) and functional class(NYHA).', 'timeFrame': '24 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac Resynchronization', 'Dilated Cardiomyopathy', 'Stem Cells Therapy', 'Heart Failure', 'Stem Cells/Cardiac Pacing, Artificial'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '17874006', 'type': 'RESULT', 'citation': "Jacob JL, Salis FV, Ruiz MA, Greco OT. Labeled stem cells transplantation to the myocardium of a patient with Chagas' disease. Arq Bras Cardiol. 2007 Aug;89(2):e10-1. doi: 10.1590/s0066-782x2007001400014. English, Portuguese."}], 'seeAlsoLinks': [{'url': 'http://deca.org.br', 'label': 'Departamento de Estimulação Cardiaca e Arritmia.'}]}, 'descriptionModule': {'briefSummary': 'Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.', 'detailedDescription': 'About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Dilated Cardiomyopathy\n* Heart Failure\n* Optimized Therapeutics\n* Ventricular Desynchrony\n* Functional Class III or IV\n* Ejection Fraction(Echo/ Sympson) \\< 35%'}, 'identificationModule': {'nctId': 'NCT00800657', 'acronym': 'RCT and SCT', 'briefTitle': 'Stem Cells and Resynchronization Cardiac', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Molestias Cardiovasculares'}, 'officialTitle': 'Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization', 'orgStudyIdInfo': {'id': 'HFRCTC1'}, 'secondaryIdInfos': [{'id': 'HFRCTC1'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Pacing and Stem Cells Implantations.', 'type': 'PROCEDURE', 'description': 'Implantation of Cardiac Ressyncrhonization combined with the implantation of Stem Cells Hematopoietics.'}, {'name': 'Pacing and Stem Cells Implantation', 'type': 'PROCEDURE', 'description': 'Pacing and Stem Cells Implantation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15015-210', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Oswaldo Tadeu Greco, PhD', 'role': 'CONTACT', 'email': 'oswaldogreco@terra.com.br', 'phone': '55-17-3203-4000', 'phoneExt': '4038'}, {'name': 'Oswaldo Tadeu Greco, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Imc - Instituto de Moléstias Cardiovasculares', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}], 'centralContacts': [{'name': 'Oswaldo Tadeu Greco, PhD', 'role': 'CONTACT', 'email': 'oswaldogreco@terra.com.br', 'phone': '55-17-3203-4000', 'phoneExt': '4038'}, {'name': 'Ana Carolina de Abreu, MD', 'role': 'CONTACT', 'email': 'carolina.cpc@terra.com.br', 'phone': '55-17-7811-8477'}], 'overallOfficials': [{'name': 'Oswaldo Tadeu Greco, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMC - Institute of Hearth Diseases'}, {'name': 'Oswaldo Tadeu Greco, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMC- Institute of Hearth Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Molestias Cardiovasculares', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Oswaldo Tadeu Greco', 'oldOrganization': 'IMC - Instituto de Moléstias Cardiovasculares'}}}}