Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-29 @ 7:35 AM
Study NCT ID:
NCT00507468
Status:
COMPLETED
Last Update Posted:
2009-11-03
First Post:
2007-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-02', 'studyFirstSubmitDate': '2007-07-22', 'studyFirstSubmitQcDate': '2007-07-25', 'lastUpdatePostDateStruct': {'date': '2009-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of treatment', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bone marrow', 'autologous', 'ejection fraction', 'left ventricle', 'heart attack', 'myocardial infarction', 'left ventricular dysfunction post myocardial infarction'], 'conditions': ['Ventricular Dysfunction', 'Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The object of this open-labeled, uncontrolled pilot study was to investigate the safety and feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the myocardium using the helical needle transendocardial (TE) delivery system in stable coronary patients with ventricular dysfunction due to chronic myocardial infarction (MI).\n\nA secondary goal was to assess the possibility that such cell injections could improve ejection fraction (EF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be 18 years of age or older\n* Able to give informed consent\n* Must have documentation of prior myocardial infarction with left ventricular ejection fraction of less than 40 percent at baseline\n* Must be a candidate for percutaneous heart catheterization\n* Must have identifiable area of transmural scar within the left ventricle\n\nExclusion Criteria:\n\n* Be a candidate for concurrent ventricular surgical restoration, AICD placement or valvular surgery\n* Clinical evidence of infection\n* Other complicating cardiovascular abnormalities\n* Clinically significant electrocardiographic abnormalities\n* Active malignancy\n* Recent history or drug or alcohol abuse\n* Pregnancy, planned or current\n* Artificial aortic valve\n* Ejection fraction less than 30 percent at baseline\n* Myocardial infarction in the past 4 weeks'}, 'identificationModule': {'nctId': 'NCT00507468', 'acronym': 'TABMMI', 'briefTitle': 'Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioCardia, Inc.'}, 'officialTitle': 'Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone', 'orgStudyIdInfo': {'id': 'ABM-MI-10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transendocaridal Transplantation of Autologous Bone Marrow', 'type': 'PROCEDURE', 'description': 'Single treatment, harvest and transplant of patients own bone marrow. Cells are delivered to the myocardium via transendocardial delivery catheter.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1118', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Swiss Clinic', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1122', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Argentine Institute of Diagnosis and Treatment', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Luis de la Fuente, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Argentine Institute of Diagnosis and Treatment'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioCardia, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Peter Altman', 'oldOrganization': 'BioCardia, Inc'}}}}