Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-11 @ 3:40 AM
Study NCT ID:
NCT02425358
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2015-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-23', 'studyFirstSubmitDate': '2015-04-15', 'studyFirstSubmitQcDate': '2015-04-23', 'lastUpdatePostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of left ventricular eject factor (LVEF) from the baseline', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change of left ventricular end-diastolic volume (LVESV) from the baseline', 'timeFrame': '12 months'}, {'measure': 'Change of left ventricular end-systolic volume (LVEDV) from the baseline', 'timeFrame': '12 months'}, {'measure': 'Change of myocardial perfusion from the baseline', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cell therapy', 'BMC', 'timing'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '19420003', 'type': 'BACKGROUND', 'citation': 'Yao K, Huang R, Sun A, Qian J, Liu X, Ge L, Zhang Y, Zhang S, Niu Y, Wang Q, Zou Y, Ge J. Repeated autologous bone marrow mononuclear cell therapy in patients with large myocardial infarction. Eur J Heart Fail. 2009 Jul;11(7):691-8. doi: 10.1093/eurjhf/hfp062. Epub 2009 May 6.'}, {'pmid': '18381377', 'type': 'BACKGROUND', 'citation': 'Yao K, Huang R, Qian J, Cui J, Ge L, Li Y, Zhang F, Shi H, Huang D, Zhang S, Sun A, Zou Y, Ge J. Administration of intracoronary bone marrow mononuclear cells on chronic myocardial infarction improves diastolic function. Heart. 2008 Sep;94(9):1147-53. doi: 10.1136/hrt.2007.137919. Epub 2008 Apr 1.'}, {'pmid': '26021558', 'type': 'DERIVED', 'citation': 'Huang R, Yao K, Sun A, Qian J, Ge L, Zhang Y, Niu Y, Wang K, Zou Y, Ge J. Timing for intracoronary administration of bone marrow mononuclear cells after acute ST-elevation myocardial infarction: a pilot study. Stem Cell Res Ther. 2015 May 29;6(1):112. doi: 10.1186/s13287-015-0102-5.'}]}, 'descriptionModule': {'briefSummary': 'Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary intervention (PCI); however, the optimal timing is unknown. The present study assessed the therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).', 'detailedDescription': 'On the basis of experimental studies that bone marrow mononuclear cells (BMCs) transfer in the injured tissue can promote regional myocardial perfusion and improved cardiac function, several clinical trials have shown that intracoronary bone marrow mononuclear cell (BMC) transplantation in acute myocardial infarction (AMI) patients several days after myocardial reperfusion is safe and may enhance the improvement of left ventricular ejection fraction (LVEF). The timing of BMC administration, baseline LVEF, dosage of BMC and other factors has been linked to improvement in LVEF after BMC transplantation. In our previous work, we gave BMCs within 24 hours after emergency percutaneous coronary intervention (PCI) and found that it was safe and effective . In addition, there are another report about longer time from symptom onset to BMC infusion (2-4 weeks), which also appeared effective . The timing of intracoronary stem cell administration may have a critical effect on cell engraftment and may be responsible for the various biological and functional responses to therapy. However, few studies have directly addressed the optimal timing of cell injections. Therefore, in this prospective randomized study, BMCs were given at different times (within 24 hours, 3 to 7 days, or 7 to 30 days after reperfusion) to investigate whether the timing of therapy affects the therapeutic response of AMI patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a history of first acute ST-elevation myocardial infarction\n* treatment with successful PCI two to twelve hours after symptom onset\n* LVEF less than 50% on angiography immediately after emergency PCI or rescue PCI\n\nExclusion Criteria:\n\n* previous Q-wave myocardial infarction\n* cardiogenic shock\n* severe coexisting conditions such as acute and chronic heart failure, malignant\n* arrhythmia, renal failure and severe bleeding that interfered with the ability of the\n* patient to comply with the protocol'}, 'identificationModule': {'nctId': 'NCT02425358', 'briefTitle': 'Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Dalian Medical University'}, 'officialTitle': 'Timing for Intracoronary Administration of Bone Marrow Mononuclear Cells After Acute ST-elevated Myocardial Infarction: a Pilot Study', 'orgStudyIdInfo': {'id': '2004BA714B05-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMC therapy within 24 hours', 'description': 'Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 24 hours after successful primary PCI.', 'interventionNames': ['Other: BMC therapy within 24 hours']}, {'type': 'EXPERIMENTAL', 'label': 'BMC therapy within 3-7 days', 'description': 'Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 3-7days after successful primary PCI.', 'interventionNames': ['Other: BMC therapy within 3-7 days']}, {'type': 'EXPERIMENTAL', 'label': 'BMC therapy within 7-30 days', 'description': 'Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 7-30days after successful primary PCI.', 'interventionNames': ['Other: BMC therapy within 7-30 days']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCI only', 'description': 'Patients with acute myocardial infarction who were performed successful primary PCI.', 'interventionNames': ['Other: PCI only']}], 'interventions': [{'name': 'BMC therapy within 24 hours', 'type': 'OTHER', 'description': 'The BMCs were isolated by Ficoll density gradient centrifugation on Lymphocyte Separation Medium. BMCs were infused into IRA at the site of the previous occlusion. This was accomplished with the use of a microtubular. After positioning of the microtubular into the distal segment vessel of the stent position in the infarct-related artery, 15 milliliter of the whole cell suspension was slowly administered via microtubular. The usual time should be over 10min to prevent back-flow and to prolong cellular contact time for cellular migration into the tissue. Patients in BMC therapy group within 24 hours remained in the cath-lab until the entire procedure, including primary PCI and intracoronary BMC infusion, was completed.', 'armGroupLabels': ['BMC therapy within 24 hours']}, {'name': 'BMC therapy within 3-7 days', 'type': 'OTHER', 'description': 'Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.', 'armGroupLabels': ['BMC therapy within 3-7 days']}, {'name': 'BMC therapy within 7-30 days', 'type': 'OTHER', 'description': 'Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.', 'armGroupLabels': ['BMC therapy within 7-30 days']}, {'name': 'PCI only', 'type': 'OTHER', 'description': 'The saline was intracoronary infusion with the use of microtubular.', 'armGroupLabels': ['PCI only']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rchuang', 'investigatorAffiliation': 'The First Affiliated Hospital of Dalian Medical University'}}}}