Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-08 @ 4:08 AM
Study NCT ID:
NCT03145402
Status:
UNKNOWN
Last Update Posted:
2020-03-17
First Post:
2017-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-10-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': '12 months', 'description': 'The rate of patients mortality after transplantation'}, {'measure': 'Hospitalization', 'timeFrame': '12 months', 'description': 'the rate of hospitalization after transplantation'}], 'secondaryOutcomes': [{'measure': 'Ejection fraction changes', 'timeFrame': '12 months', 'description': 'Elevation of ejection fraction in patients after transplantation'}, {'measure': '6-minute walk test (6MWT)', 'timeFrame': '12 months', 'description': 'Evaluation the improvement of 6MWT test after transplantation'}, {'measure': 'Pro b-type natriuretic peptide (Pro-BNP) changes', 'timeFrame': '12 months', 'description': 'Elevation the reduction of Pro-BNP in patients after transplantation'}, {'measure': 'NYHA functional class', 'timeFrame': '12 months', 'description': 'Evaluation the improvement of NYHA functional class in patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomised double blind, controlled, parallel-group phase I and II study. Its aim is to assess that a single intracoronary infusion of autologous bone marrow-mononuclear cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(\\<=30%) when compared to a control group of patients undergoing best medical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women of any ethnic origin 18 ≤ aged≤ 65 years\n2. EF≤40 (by Echocardiography) and regional wall motion abnormality\n3. Not responding to standard therapies\n4. the New York Heart Association (NYHA) class ≥ III\n5. Myocardial infarction due to coronary artery atherosclerotic disease\n6. An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI)\n7. Normal liver and renal function\n8. No or controlled diabetes\n9. Able to give voluntary written consent and understand the study information provided to him\n\nExclusion Criteria:\n\n1. Participation in another clinical trial within 30 days prior randomisation\n2. Previously received stem/progenitor cell therapy\n3. Pregnant women\n4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol\n5. Cardiogenic shock requiring mechanical support\n6. Congenital / valvular heart disease\n7. Implantable cardioverter defibrillator (ICD) transplant\n8. Platelet count \\<100.000/µl, or hemoglobin \\<8.5 g/dl\n9. Impaired renal function, i.e. creatinine \\>2.5 mg/dl\n10. Fever or diarrhea within 4 weeks prior screening\n11. History of bleeding disorder within 3 months prior screening\n12. Uncontrolled hypertension (systolic \\>180 mmHg and diastolic \\>120 mmHg) or Sustained ventricular arrhythmia\n13. Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease'}, 'identificationModule': {'nctId': 'NCT03145402', 'acronym': 'ICMNC-HF', 'briefTitle': 'ICMNC-HF. IntraCoronary Bone Marrow MonoNuclear Cells in Heart Failure (HF) Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'SCARM Institute, Tabriz, Iran'}, 'officialTitle': 'The Effect of Intracoronary Autologous Bone Marrow Derived Mononuclear Stem Cell Transplantation in Heart Failure (HF) Patients', 'orgStudyIdInfo': {'id': 'SCARM-Heart-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracoronary injection of stem cell', 'description': 'Autologous bone marrow-derived mononuclear cells injection in patients with Heart Failure', 'interventionNames': ['Biological: Intracoronary injection of stem cell']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo injection via coronary arteries in patients with Heart Failure', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Intracoronary injection of stem cell', 'type': 'BIOLOGICAL', 'description': 'Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed in patients with Heart failure via conventional percutaneous intracoronary intervention techniques.', 'armGroupLabels': ['Intracoronary injection of stem cell']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Injection of Placebo in patients with Heart failure via coronary arteries', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tabriz', 'country': 'Iran', 'contacts': [{'name': 'Peyman Keyhanvar, MD, Ph.D', 'role': 'CONTACT', 'phone': '0914 114 6863'}, {'name': 'Yousef Faridvand, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stem Cell And Regenerative Medicine institute (SCARM)', 'geoPoint': {'lat': 38.08, 'lon': 46.2919}}], 'centralContacts': [{'name': 'Nasser Aslanabadi, MD, Cardiologist', 'role': 'CONTACT', 'email': 'aslanabadin@yahoo.com', 'phone': '0413 33349525'}, {'name': 'Peyman Keyhanvar, MD, Ph.D', 'role': 'CONTACT', 'email': 'drkeyhanvar@gmail.com', 'phone': '0413 33349525'}], 'overallOfficials': [{'name': 'Nasser Aslanabadi, MD, Cardiologist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tabriz University of Medical Sciences'}, {'name': 'Mohammad Nouri, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of SCARM institute'}, {'name': 'Peyman Keyhanvar, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deputy for translational medicine of SCARM institute'}, {'name': 'Raheleh Farahzadi, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran'}, {'name': 'Yousef Faridvand, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SCARM institute'}, {'name': 'Elgar Anamzadeh, MD, Cardiologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tabriz University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SCARM Institute, Tabriz, Iran', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}