Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-03-19 @ 12:44 AM
Study NCT ID:
NCT01758406
Status:
UNKNOWN
Last Update Posted:
2015-12-04
First Post:
2012-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transplantation of Autologous Cardiac Stem Cells in Ischemic 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2012-12-24', 'studyFirstSubmitQcDate': '2012-12-24', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death', 'timeFrame': '18months', 'description': 'evaluation the rate of patients mortality after cardiac stem cell transplantation.'}, {'measure': 'arrhythmia', 'timeFrame': '18months', 'description': 'Evaluation rate of arrhythmia after cardiac stem cell transplantation'}, {'measure': 'hospitalization', 'timeFrame': '18 months', 'description': 'Evaluation the rate of hospitalization after cardiac stem cell transplantation'}], 'secondaryOutcomes': [{'measure': 'Ejectin fraction changes', 'timeFrame': '18months', 'description': 'evaluation the elevation of ejection fraction in patients after cardiac stem cell transplantation.'}, {'measure': 'Pro BNP changes', 'timeFrame': '18months', 'description': 'Evaluation the reduction of Pro BNP in patients after cardiac stem cell transplantation.'}, {'measure': 'NYHA functional class', 'timeFrame': '18months', 'description': 'Evaluation the improvement of NYHA functional class in patients after cardiac stem cell transplantation.'}, {'measure': '6MW test', 'timeFrame': '18months', 'description': 'Evaluation the improvement of 6MW test after cardiac stem cell transplantation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac stem ce heart failure cardiac function intracoronary transplantation'], 'conditions': ['Heart Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://Royaninstitute.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective, randomized, double blind , controlled trial to assess the efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients with ischemic heart failure.', 'detailedDescription': 'Heart failure is a common, costly, disabling, and potentially deadly condition. Heart transplantation is the ultimate approach to treating heart failure, but this is costly and excludes patients who are poor candidates for transplantation given their co morbidities, or for whom a donor organ is unavailable. Currently, there is no effective intervention to regenerate dead heart muscle after a heart attack. Our hypothesis is that CSCs regenerates myocardium. In this study all eligible patients are randomly allocated into two study groups by a permuted block randomization method: group A (case group) received 5-10 millions autologous cardiac stem cells, group B (control group) just received placebo. They follow up for 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1- EF≤40 (by Echocardiography) 2- Not responding to standard therapies for heart failure \\>1m 3- NYHA class ≥ III 4- Myocardial infarction due to coronary artery atherosclerotic disease 5-An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI) 6-No HIV/Viral hepatitis 7-Normal liver function (SGPT \\< 3 times the upper reference range) 8-No or controlled diabetes (hemoglobin A1C \\< 8.5%) 9- Ability to provide informed consent and follow-up with protocol procedures\n\nExclusion Criteria:\n\n* 1 prior ICD placement(\\<2w)/Sustained ventricular arrhythmias 2-Cardiogenic shock 3- pregnancy and Child-bearing 4- Congenital / valvular heart disease'}, 'identificationModule': {'nctId': 'NCT01758406', 'briefTitle': 'Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Therapeutic Outcome of Intracoronary Transplantation of Autologous Cardiac Stem Cells in Patients With Ischemic Heart Failure: Randomized Double Blind Clinical Trial', 'orgStudyIdInfo': {'id': 'Royan-Heart-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cardiac stem cell transplantation', 'description': 'The patients with heart failure that underwent cardiac stem cell transplantation.', 'interventionNames': ['Biological: Intracoronary injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The patients with heart failure that underwent placebo injection.', 'interventionNames': ['Biological: Intracoronary injection of Placebo']}], 'interventions': [{'name': 'Intracoronary injection', 'type': 'BIOLOGICAL', 'otherNames': ['autologous cardiac stem cell intracoronary injection'], 'description': 'stem cell transplantation', 'armGroupLabels': ['cardiac stem cell transplantation']}, {'name': 'Intracoronary injection of Placebo', 'type': 'BIOLOGICAL', 'description': 'Injection of Placebo via coronary arteries in patients with heart failure.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Nasser Aghdami, MD,PhD', 'role': 'CONTACT', 'email': 'nasser.aghdami@royaninstitute.org', 'phone': '+982123562000', 'phoneExt': '504'}, {'name': 'Leila Arab, MD', 'role': 'CONTACT', 'email': 'leila.arab@yahoo.com', 'phone': '+982123562000', 'phoneExt': '414'}, {'name': 'Hoda Madani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sadaf Vahdat, PhD student', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Royan Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Nasser Aghdami, MD,PhD', 'role': 'CONTACT', 'email': 'nasser.aghdami@royaninstitute.org', 'phone': '+9821235622000', 'phoneExt': '504'}, {'name': 'Leila Arab, MD', 'role': 'CONTACT', 'email': 'leila.arab@yahoo.com', 'phone': '+982123562000', 'phoneExt': '414'}], 'overallOfficials': [{'name': 'Hamid Gourabi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of Royan Institute'}, {'name': 'Nasser Aghdami, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of Royan department of degenerative medicine'}, {'name': 'Ahmad Amin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Heart failure,Shahid Rajaee Hospital'}, {'name': 'Farveh Vakilian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Heart failure , Imam reza hospital, Mashhad, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}