Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-03-14 @ 9:36 PM
Study NCT ID:
NCT01167751
Status:
COMPLETED
Last Update Posted:
2016-06-21
First Post:
2010-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071916', 'term': 'AC133 Antigen'}], 'ancestors': [{'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-19', 'studyFirstSubmitDate': '2010-07-19', 'studyFirstSubmitQcDate': '2010-07-21', 'lastUpdatePostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular ejection fraction at rest, measured by gated SPECT', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Regional contractility in the AOI / Change in LV dimensions (left ventricular end systolic diameter [LVESD], left ventricular end diastolic diameter [LVEDD]) as assessed by echocardiography', 'timeFrame': '6 months'}, {'measure': 'changes in LVM index, LVEDV, LVESV', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial infarction', 'Bone marrow stem cells', 'AC133'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '17691968', 'type': 'BACKGROUND', 'citation': 'Ahmadi H, Baharvand H, Ashtiani SK, Soleimani M, Sadeghian H, Ardekani JM, Mehrjerdi NZ, Kouhkan A, Namiri M, Madani-Civi M, Fattahi F, Shahverdi A, Dizaji AV. Safety analysis and improved cardiac function following local autologous transplantation of CD133(+) enriched bone marrow cells after myocardial infarction. Curr Neurovasc Res. 2007 Aug;4(3):153-60. doi: 10.2174/156720207781387141.'}, {'pmid': '29633605', 'type': 'DERIVED', 'citation': 'Naseri MH, Madani H, Ahmadi Tafti SH, Moshkani Farahani M, Kazemi Saleh D, Hosseinnejad H, Hosseini S, Hekmat S, Hossein Ahmadi Z, Dehghani M, Saadat A, Mardpour S, Hosseini SE, Esmaeilzadeh M, Sadeghian H, Bahoush G, Bassi A, Amin A, Fazeli R, Sharafi Y, Arab L, Movahhed M, Davaran S, Ramezanzadeh N, Kouhkan A, Hezavehei A, Namiri M, Kashfi F, Akhlaghi A, Sotoodehnejadnematalahi F, Vosough Dizaji A, Gourabi H, Syedi N, Shahverdi AH, Baharvand H, Aghdami N. COMPARE CPM-RMI Trial: Intramyocardial Transplantation of Autologous Bone Marrow-Derived CD133+ Cells and MNCs during CABG in Patients with Recent MI: A Phase II/III, Multicenter, Placebo-Controlled, Randomized, Double-Blind Clinical Trial. Cell J. 2018 Jul;20(2):267-277. doi: 10.22074/cellj.2018.5197. Epub 2018 Mar 18.'}], 'seeAlsoLinks': [{'url': 'http://www.royaninstitute.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'One of the important reasons for human dying is Ischemic heart disease (IHD). The most reason is coronary artery disease. Beside morbidity, IHD induce myocardial infarction and necrosis which due to congestive heart failure.\n\nOne therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method to prevent ventricular remodeling after acute myocardial infarction. Human and animal studies have shown that stem cell trans plantation to myocardial infarcted zone can improve heart contractile function.\n\nThe aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation in patients with myocardial infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CABG candidate\n* At least 4 akinetic segments\n* First anterior heart attack within in 10 days to 3 month.\n* St elevation MI defined by: Post Acute MI LVEF less than 45% as assessed by echocardiography.\n* The target lesion had to be located in the left anterior descending (LAD) section.\n\nExclusion Criteria:\n\n* History of prior anterior myocardial infarction:\n* History of prior CABG\n* Poor echocardiography window.\n* Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBSAg/ Anti HBc Anti - Hcv) HIV and HTLV-l\n* Documental terminal illness or malignancy.\n* Previous bone marrow transplant\n* Autoimmune disease (e. g Lupus, Multiple sclerosis)\n* Any contraindication for bone - marrow aspiration.\n* Positive pregnancy test (in women with child bearing potential)'}, 'identificationModule': {'nctId': 'NCT01167751', 'briefTitle': 'Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Autologous Bone Marrow Derived Ac 133+ and Mono Nuclear Cells In-patient With Acute Myocardial Infarction During Coronary Artery Bypass Grafting (CABG): A Randomized Phase III Clinical Trial', 'orgStudyIdInfo': {'id': 'Royan-Heart-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MNC implantation', 'description': 'Implantation of BM derived MNC', 'interventionNames': ['Biological: MNC']}, {'type': 'EXPERIMENTAL', 'label': 'AC 133 implantation', 'description': 'Implantation of BM derived AC 133', 'interventionNames': ['Biological: AC 133']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Injection of cell carrier', 'interventionNames': ['Biological: Control']}], 'interventions': [{'name': 'MNC', 'type': 'BIOLOGICAL', 'otherNames': ['MNC injection'], 'description': 'Implantation of BM derived MNC', 'armGroupLabels': ['MNC implantation']}, {'name': 'AC 133', 'type': 'BIOLOGICAL', 'otherNames': ['AC133 injection'], 'description': 'Implantation of BM derived AC133', 'armGroupLabels': ['AC 133 implantation']}, {'name': 'Control', 'type': 'BIOLOGICAL', 'otherNames': ['Placebo'], 'description': 'Injection of cell carrier', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Royan Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Hamid Gourabi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Royan Institute'}, {'name': 'Hossein Baharvand, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royan Institute'}, {'name': 'Mohammadhassan Nasseri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baghiatollah'}, {'name': 'Nasser Aghdami, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Royan Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}