Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02871466
Status:
UNKNOWN
Last Update Posted:
2020-08-13
First Post:
2016-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stem Cells Therapy in Advanced Heart Failure
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2016-08-10', 'studyFirstSubmitQcDate': '2016-08-17', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NYHA class improvement', 'timeFrame': '12 months'}, {'measure': 'reduction in hospitalization rate', 'timeFrame': '12 months'}, {'measure': 'reduction in angor symptoms', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': 'stem cells therapy may be a choice therapy for advanced heart failure patients refractory to medical therapy, internal cardiovertor with a defibrillator (ICD) recipients, and a previous history of myocardial infarction and coronary artery revascularization. These patients, without indication to receive a cardiac resynchronization therapy (CRT), may have a worsening of heart failure, and symptoms of coronary artery disease. In this study we have evaluated in consecutive 30 selected patients the amelioration in failing heart NYHA class, hospitalization rate, echocardiographic left ventricle functionality, and associated to reduction of angina after a treatment with stem cells intra thoracic infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* heart failure post coronary artery disease, refractory to maximal medical therapy, previous coronary artery surgical revascularization.\n\nExclusion Criteria:\n\n* inflammatory chronic diseases, neoplastic diseases.'}, 'identificationModule': {'nctId': 'NCT02871466', 'briefTitle': 'Stem Cells Therapy in Advanced Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Intra Cardiac Autologous Stem Cells Infusion May Improve Clinical Outcomes in Failing Heart Subjects Refractory to Maximal Drug Therapy and Internal Cardioverter With a Defibrillator (ICD) Recipients', 'orgStudyIdInfo': {'id': '8.2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stem cells infusion', 'interventionNames': ['Drug: stem cells infusion']}], 'interventions': [{'name': 'stem cells infusion', 'type': 'DRUG', 'armGroupLabels': ['stem cells infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Raffaele Marfella', 'role': 'CONTACT'}], 'facility': 'Celestino Sardu', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '80138', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Raffaele Marfella, MD, PhD', 'role': 'CONTACT', 'email': 'raffaele.marfella@unicampania.it', 'phone': '+39 0810815665110'}, {'name': 'Celestino Sardu, MD, MSc, PhD', 'role': 'CONTACT', 'email': 'drsarducele@gmail.com', 'phone': '+393336664543'}], 'facility': 'Raffaele Marfella', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Raffaele Marfella', 'role': 'CONTACT'}], 'facility': 'Celestino Sardu', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'centralContacts': [{'name': 'Raffaele Marfella, MD, PhD', 'role': 'CONTACT', 'email': 'raffaele.marfella@unicampania.it', 'phone': '00390815566101'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Celestino Sardu', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}