Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2026-01-03 @ 1:53 PM
Study NCT ID:
NCT00480961
Status:
UNKNOWN
Last Update Posted:
2007-06-01
First Post:
2007-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-05-31', 'studyFirstSubmitDate': '2007-05-31', 'studyFirstSubmitQcDate': '2007-05-31', 'lastUpdatePostDateStruct': {'date': '2007-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients.', 'timeFrame': '1 YEAR'}], 'secondaryOutcomes': [{'measure': 'Secondary target: determine clinical effects of grafted cells on remodeling pathology.', 'timeFrame': '1 YEAR'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': 'This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischemic etiology. Cellular implantation will take place during off-pump revascularization surgery or during an ad hoc procedure using a mini-thoracotomy access.', 'detailedDescription': 'Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients. Secondary target: determine clinical effects of grafted cells on remodeling pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Age \\>18 y/o\n* CHF with EF \\> 35%\n* Bilirubinemia, serum transaminase\\> 2.5 times normal max level\n* Creatininemia \\> 2.5 times max level\n* NYHA Class \\> 3\n* Negative pregnancy test (for women in fertile age)\n\nExclusion criteria\n\n* Impossibility to harvest the bone marrow\n* Pregnancy or breast-feeding\n* History of malignant neoplasia in the 5-year period before the study (save for in-situ carcinoma of the cervix treated successfully and skin tumors - not melanomas)\n* Incapability or unwillingness to comply with the envisaged treatment protocol, follow-up, or tests.'}, 'identificationModule': {'nctId': 'NCT00480961', 'briefTitle': 'Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy', 'organization': {'class': 'OTHER', 'fullName': 'The Mediterranean Institute for Transplantation and Advanced Specialized Therapies'}, 'orgStudyIdInfo': {'id': 'IRRB/00/2006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intramiocardiac autograft of autologous stem cells', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90127', 'city': 'Palermo', 'state': 'pa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'CESARE SCARDULLA, md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ismett', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}], 'centralContacts': [{'name': 'cesare scardulla, MD', 'role': 'CONTACT', 'email': 'cscardulla@ISMETT.edu', 'phone': '0912192284'}], 'overallOfficials': [{'name': 'CESARE SCARDULLA, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Mediterranean Institute for Transplantation and Advanced Specialized Therapies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Mediterranean Institute for Transplantation and Advanced Specialized Therapies', 'class': 'OTHER'}}}}