Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-27 @ 1:08 AM
Study NCT ID:
NCT01615250
Status:
UNKNOWN
Last Update Posted:
2012-06-11
First Post:
2012-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-08', 'studyFirstSubmitDate': '2012-06-06', 'studyFirstSubmitQcDate': '2012-06-07', 'lastUpdatePostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in global left ventricular ejection fraction and regional wall motion score index', 'timeFrame': '6 and12 months', 'description': 'Change in global left ventricular ejection fraction and regional wall motion score index.'}], 'secondaryOutcomes': [{'measure': 'Incidence of the major adverse cardiac events', 'timeFrame': '6 and 12 months', 'description': 'Incidence of the major adverse cardiac events.'}]}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This is a randomized study of efficiency and safety of intramyocardial implantation of peripheral mononuclear cells with high concentration of CD34+ stem cells in patients with myocardial ischemia after preparatory course of shock - wave therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ischemic cardiomyopaty and HF II-IV NYHA class\n* MI more than 6 months before the study\n* LVEF less than 35%\n* Absence effect of coronary revascularization during 6 months\n* Optimal pharmacological therapy no less than 8 weeks\n* Heart transplantation is contraindicated\n* Patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)\n* Patients giving informed consent\n\nExclusion Criteria:\n\n* Acute coronary syndrome\n* Coronary revascularization less than 6 months\n* Patients requiring surgical correction of post-MI aneurism\n* LV wall thickness less than 5 mm in site of possible injection\n* Patients with CRT implanted within 3 month before cells injection\n* Clinically significant associated diseases\n* Active oncology desiase\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01615250', 'acronym': 'ISCIC', 'briefTitle': 'Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Odessa National Medical University'}, 'officialTitle': 'Phase I Study to Evaluate the Efficacy and Safety of Intramyocardial Implantation of Peripheral Mononuclear Cells With CD34+ Stem Cells in Patient With Ischemic Cardiomyopathy After Preparatory Course of Shock - Wave Therapy', 'orgStudyIdInfo': {'id': 'ISCIC-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard therapy', 'description': 'Treatment with standard therapy. Cardiospec shock-wave therapy'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stem cells', 'description': 'Group of of intramyocardial implantation of peripheral mononuclear cells with CD34+ stem cells in patient with ischemic cardiomyopathy after preparatory course of shock - wave therapy.', 'interventionNames': ['Biological: Intramyocardial implantation of stem cells']}], 'interventions': [{'name': 'Intramyocardial implantation of stem cells', 'type': 'BIOLOGICAL', 'description': 'Intramyocardial implantation of autologous peripheral mononuclear cells with CD34+ stem cells by NOGA.XP navigation system. Сell concentration is 200 million cells in 1 ml.', 'armGroupLabels': ['Stem cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65025', 'city': 'Odesa', 'status': 'RECRUITING', 'country': 'Ukraine', 'contacts': [{'name': 'Iurii I Karpenko, Dr, PhD', 'role': 'CONTACT', 'email': 'arcard2@gmail.com', 'phone': '+380487500115', 'phoneExt': '+380487500115'}], 'facility': 'Odessa Regional Clinical Hospital', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}], 'centralContacts': [{'name': 'Iurii I Karpenko, Dr, PhD', 'role': 'CONTACT', 'email': 'arcard2@gmail.com', 'phone': '+38048750113', 'phoneExt': '+38048750113'}], 'overallOfficials': [{'name': 'Iurii I Karpenko, Dr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odessa National Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odessa National Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr., PhD Iurii I Karpenko', 'investigatorFullName': 'Iurii Kozlov', 'investigatorAffiliation': 'Odessa National Medical University'}}}}