Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-02 @ 2:44 AM
Study NCT ID:
NCT00529932
Status:
TERMINATED
Last Update Posted:
2015-04-22
First Post:
2007-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Insufficient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2007-09-13', 'studyFirstSubmitQcDate': '2007-09-13', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PRIMARY SAFETY ENDPOINT Comparison of progression in coronary atherosclerosis burden proximal and distal to the stented segment of the infarct-related artery in treated and control groups.', 'timeFrame': 'at 6 months post-infusion'}, {'measure': 'PRIMARY EFFICACY ENDPOINT Comparison of changes in myocardial thickening in non-viable akinetic / hypokinetic LV wall segments as determined by cardiac magnetic resonance imaging (cMRI) in treated and control groups.', 'timeFrame': 'at 6 and 24 months'}], 'secondaryOutcomes': [{'measure': 'SECONDARY SAFETY ENDPOINT (a) Development of ventricular arrhythmias including failed sudden cardiac death. (b) Development of congestive heart failure.', 'timeFrame': "At all follow up's"}, {'measure': 'SECONDARY EFFICACY ENDPOINTS (a) Changes in % global LV ejection fraction (EF) compared with baseline as determined by cMRI and echocardiography pre- and post-cell infusion subsequent to primary PCI.', 'timeFrame': "at all follow up's"}, {'measure': 'SECONDARY EFFICACY ENDPOINTS (b)Assessment of epicardial resistance and microvascular resistance, index of myocardial resistance and absolute coronary blood flow measurements in the infarct related artery.', 'timeFrame': 'at 6 months follow up'}, {'measure': 'SECONDARY EFFICACY ENDPOINTS (c) The feasibility of the CliniMACS® Reagent System to yield 5x106 CD133+ cells from 100-150 ml of autologous bone marrow.', 'timeFrame': 'prior to the infusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Myocardial Infarction', 'Celltherapy', 'Bone Marrow'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'An international, multi-centre, double-blind, randomised, placebo-controlled clinical trial with central core lab analyses to determine the safety of intra-coronary infusion of enriched CD133+, bone marrow-derived, autologous progenitor cells in patients 5-10 days after acute percutaneous coronary revascularization (primary PCI) for ST-segment elevation myocardial infarction (STEMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary PCI for acute STEMI between 2-24 hours after onset of chest pain.\n* ST-segment elevation \\>=2mm in \\>=3 adjacent leads.\n* Presence of severe hypokinesia and/or akinesia in \\>=2 adjacent segments on echocardiogram at 48-72 hrs after primary PCI.\n* Age between 20 and 75 years.\n\nExclusion Criteria:\n\n* Pregnant or lactating.\n* Prior history of myocardial infarction before index event.\n* Decompensated congestive heart failure.\n* Pre-existent LV dysfunction (EF \\<45% prior to admission)\n* Cardiomyopathy.\n* Previous cardiac surgery.\n* Congenital heart disorder.\n* Serum creatinine \\>200 Mmol/L.\n* Presence of permanent pacemaker or implantable defibrillator.\n* Contraindication to bone marrow aspiration.\n* History of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma and/or cervical carcinoma.\n* Sustained or inducible VT \\>48 hours post primary PCI.\n* Three vessel coronary artery disease necessitating intervention within 4 months.\n* Immune compromise including chronic human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.\n* Presence of chronic systemic inflammatory disorders.\n* Previous autologous or allogeneic bone marrow or peripheral stem cell transplant or prior solid organ transplantation.\n* Low hemoglobin, white blood cell, absolute neutrophil and/or platelet count.\n* Any condition associated with a life expectancy of less than 6 months.\n* Participation in unrelated research involving investigational pharmacological agent(s) 30 days before planned dosing.\n* Current alcohol or drug abuse.\n* Inability to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT00529932', 'acronym': 'SELECT-AMI', 'briefTitle': 'A Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Onze Lieve Vrouw Hospital'}, 'officialTitle': 'A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'SELECT-AMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Enriched CD133+, bone marrow-derived, autologous progenitor cells for this trial will be infused in the coronary arteries', 'interventionNames': ['Other: CD133+ infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Control group patients will receive 3 injections of 0.3 mL each of buffered normal saline (the vehicle used for cell suspension) into comparable vessels. Subjects will have an identical intra-coronary injection procedure to those randomized to autologous CD133+ progenitor cell injections.', 'interventionNames': ['Other: placebo infusion']}], 'interventions': [{'name': 'CD133+ infusion', 'type': 'OTHER', 'description': 'Subjects will be infused with all available autologous CD133+ cells after processing during one infusion session (during angiography).', 'armGroupLabels': ['1']}, {'name': 'placebo infusion', 'type': 'OTHER', 'description': 'Buffered normal saline will be infused in the coronary artery during an angiography.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9400', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLVZ Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU ST-Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Cardiologique', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's College University Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Jozef Bartunek, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'OLVZ Aalst'}, {'name': 'Jonathan Hill, MD', 'role': 'STUDY_CHAIR', 'affiliation': "King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jozef Bartunek', 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Jozef Bartunek', 'investigatorFullName': 'Jozef Bartunek', 'investigatorAffiliation': 'Onze Lieve Vrouw Hospital'}}}}