Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-29 @ 3:15 AM
Study NCT ID:
NCT00135850
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2005-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-10', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-04', 'studyFirstSubmitDate': '2005-08-25', 'studyFirstSubmitQcDate': '2005-08-25', 'lastUpdatePostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in myocardial perfusion measured by single photon emission computerized tomography (SPECT)'}], 'secondaryOutcomes': [{'measure': 'Clinical improvement'}]}, 'conditionsModule': {'keywords': ['Gene therapy', 'VEGF', 'Stem cells', 'myocardial ischemia', 'angiogenesis'], 'conditions': ['Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the mobilization of non-haematopoietic mesenchymal and haematopoietic stem cells from the bone marrow with granulocyte colony stimulating factor (G-CSF) treatment alone and in combination with vascular endothelial growth factor (VEGF) gene therapy in patients with severe chronic occlusive coronary artery disease.', 'detailedDescription': 'In recent clinical trials, vascular endothelial growth factor (VEGF) delivered as plasmid DNA percutaneously by a catheter-based, intramyocardial approach, have been demonstrated to be safe and to be associated with a reduction in angina and an increase in exercise time or an improvement in regional wall motion in "no-option patients" with chronic myocardial ischemia.\n\nIt has been demonstrated, that BM-derived stem cells mobilized by cytokines as granulocyte colony stimulating factor (G-CSF) were capable of regenerating the myocardial tissue, leading to improve the survival and cardiac function after myocardial infarction.\n\nThese data suggested that a combination therapy with exogenous administration of gene vascular growth factor combined with G-CSF mobilization of bone marrow stem cells might induce both angiogenesis and vasculogenesis in ischemic myocardium'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reversible ischemia at an adenosine stress single photon emission computerized tomography (SPECT)\n* A coronary arteriography demonstrating at least one main coronary vessel from which new collaterals/vessels could be supplied\n* Age above 18 years\n* Canadian Cardiovascular Society angina classification (CCS) \\> 3.\n\nExclusion Criteria:\n\n* Ejection fraction \\<0.40\n* Unstable angina pectoris\n* Acute myocardial infarction within the last three months\n* Diabetes mellitus with proliferative retinopathy\n* Diagnosed or suspected cancer disease\n* Chronic inflammatory disease\n* Premenopausal women'}, 'identificationModule': {'nctId': 'NCT00135850', 'briefTitle': 'The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Effect of Mobilized Stem Cell by G-CSF and VEGF Gene Therapy in Patients With Stable Severe Angina Pectoris', 'orgStudyIdInfo': {'id': 'Gene G-CSF'}}, 'armsInterventionsModule': {'interventions': [{'name': 'VEGF-A165 plasmid', 'type': 'GENETIC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen Ø', 'country': 'Denmark', 'facility': 'Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet'}], 'overallOfficials': [{'name': 'Jens Kastrup, MD DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet, DK-2100 Copenhagen Ø, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}