Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-19 @ 5:27 PM
Study NCT ID:
NCT00400959
Status:
COMPLETED
Last Update Posted:
2006-11-17
First Post:
2006-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD133+ Autologous Cells After Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2006-10'}, 'lastUpdateSubmitDate': '2006-11-15', 'studyFirstSubmitDate': '2006-11-14', 'studyFirstSubmitQcDate': '2006-11-15', 'lastUpdatePostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),'}, {'measure': 'Ejection fraction (%) evaluated by 2D echocardiography;'}], 'secondaryOutcomes': [{'measure': 'perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);'}, {'measure': 'Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D'}]}, 'conditionsModule': {'keywords': ['cell therapy', 'acute myocardial infarction'], 'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '21372740', 'type': 'DERIVED', 'citation': 'Colombo A, Castellani M, Piccaluga E, Pusineri E, Palatresi S, Longari V, Canzi C, Sacchi E, Rossi E, Rech R, Gerundini P, Viecca M, Deliliers GL, Rebulla P, Soligo D, Giordano R. Myocardial blood flow and infarct size after CD133+ cell injection in large myocardial infarction with good recanalization and poor reperfusion: results from a randomized controlled trial. J Cardiovasc Med (Hagerstown). 2011 Apr;12(4):239-48. doi: 10.2459/JCM.0b013e328343d708.'}]}, 'descriptionModule': {'briefSummary': 'TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction.\n\nTRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.\n\nSPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (\uf053STeR) (see Poli et al., Circulation, 2002).\n\nOBJECTIVES Primary:\n\n1. To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.\n2. To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls.\n\n Secondary:\n3. To evaluate the disease-related morbility of the target population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent;\n* age: 18-65 years;\n* large acute myocardial infarction (due to proximal occlusion of the left anterior descending or the right coronary artery) after successful primary PTCA carried out between the IV and the XXIV hour from the onset of AMI symptoms;\n* signs of microvascular dysfunction in the infarcted area: absence of \uf053STeR and angiographic MB, graded according to the dye density score (see van't Hof et al., Circulation, 1998); life expectancy more than 6 months.\n\nExclusion Criteria:\n\n* Pregnancy;\n* indication to aorto-coronaric by-pass;\n* neoplasia (previous or in progress);\n* primary diseases of the BM;\n* diabetes;\n* immunosuppressive therapy;\n* laboratory alterations of protein S, protein C, ATIII or Fibrinogen;\n* severe co-morbidity."}, 'identificationModule': {'nctId': 'NCT00400959', 'briefTitle': 'CD133+ Autologous Cells After Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction', 'orgStudyIdInfo': {'id': 'CFT92002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cd133+cell intracoronary administration', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Cell Factory, department of regenerative medicine, Policlinic of Milan', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Rosaria Giordano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cell Factory Department of Regenerative Medicine Policlinic Milan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}}}}