Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 7:00 PM
Study NCT ID:
NCT00442806
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
2007-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'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'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-25', 'studyFirstSubmitDate': '2007-02-28', 'studyFirstSubmitQcDate': '2007-03-01', 'lastUpdatePostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Feasibility - Assessment of cardiac function via functional and imaging studies including MRI, SPECT, and Echocardiography', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ADRC', 'Stem Cells', 'Myocardial Infarction', 'STEMI', 'Heart Disease', 'Coronary Artery Disease', 'Coronary Disease', 'ST-Elevation', 'AMI', 'Interventional Cardiology', 'Heart Attack'], 'conditions': ['Myocardial Infarction', 'Coronary Arteriosclerosis', 'Cardiovascular Disease', 'Coronary Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction.", 'detailedDescription': "Subjects who have coronary artery disease and have suffered a ST-elevation acute myocardial infarction will be evaluated for eligibility in this study. Eligible subjects will undergo standard treatment after admission to the hospital and will then undergo liposuction under local anesthesia, after which ADRC's will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRC's or placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Acute myocardial infarction (AMI)\n* Clinical symptoms consistent with AMI for a minimum of 2 and a maximum of 12 hours from onset of symptoms to Percutaneous Coronary Intervention (PCI), and unresponsive to nitroglycerin\n* Successful revascularization of the culprit lesion in the major epicardial vessel\n* Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI\n* Left ventricular ejection fraction (LVEF) ≥30% and ≤50% by Left Ventricular Angiography at the time of successful revascularization.\n* Ability to undergo liposuction\n\nKey Exclusion Criteria:\n\n* Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF)\n* More than 24 hours after acute PCI\n* Significant valvular disease\n* More than twelve hours between the onset of first symptoms of AMI and revascularization\n* Hemodynamic instability within 24 hours prior to randomization\n* Neoplasia\n* Acute or chronic bacterial or viral infectious disease\n* Pacemaker, ICD or any other contra-indication for MRI\n* LVEF \\<30% or \\>50% by Left Ventricular Angiography\n* Moderate or severe COPD'}, 'identificationModule': {'nctId': 'NCT00442806', 'briefTitle': 'Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytori Therapeutics'}, 'officialTitle': 'A Randomized Clinical Trial of AdiPOse-derived Stem ceLLs in the Treatment of Patients With ST-elevation myOcardial Infarction - The APOLLO Trial', 'orgStudyIdInfo': {'id': 'APOLLO - 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo is injected', 'interventionNames': ['Other: Injection of Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': "ADRC's are injected", 'interventionNames': ["Drug: Injection of ADRC's"]}], 'interventions': [{'name': "Injection of ADRC's", 'type': 'DRUG', 'description': "ADRC's are injected", 'armGroupLabels': ['Treatment']}, {'name': 'Injection of Placebo', 'type': 'OTHER', 'description': 'Placebo is injected', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus University Medical Centrum, Thorax Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Eric Duckers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus University Medical Centrum, ThoraxCenter'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytori Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}