Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-02-23 @ 10:27 AM
Study NCT ID:
NCT01216995
Status:
COMPLETED
Last Update Posted:
2014-11-21
First Post:
2010-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)
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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-19', 'studyFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Infarct Size', 'timeFrame': '6 Months', 'description': 'Reduction in infarct size at 6 months as measured by cardiac MRI'}], 'secondaryOutcomes': [{'measure': 'MACCE Rates', 'timeFrame': 'Through 36 months', 'description': 'Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Attack', 'Regenerative Cells', 'Stem Cells'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).', 'detailedDescription': 'This is a prospective, randomized, two arm, placebo-controlled, double blind, study that will enroll approximately 216 patients at no more than thirty-five (35) international clinical sites. Additional blinding measures will be taken in the assessment of study outcomes. The dose of the test material (ADRCs)is described in the protocol. The study will include two arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* ST-segment Elevation Myocardial Infarction (STEMI) Criteria:\n* Ischemic symptoms AND\n* ECG:\n* Development of pathologic Q waves on the ECG; or\n* ECG changes indicative of severe ischemia (ST segment elevation and/or depression); or\n* New left bundle branch block; AND\n* Creatine Phosphokinase Isoenzyme (MB Form) \\> 100 IU/L, or troponin \\>5x the upper limit of normal between admission and randomization\n* Successful revascularization of the culprit lesion in a major epicardial vessel\n\nKey Exclusion Criteria:\n\n* More than 24 hours between PCI and start of liposuction\n* Prior myocardial infarction, cardiomyopathy, or a history of congestive heart failure\n* Pacemaker, ICD, or any other contra-indication for MRI\n* Patients with increased bleeding risk\n* Cardiogenic shock present post-index PCI'}, 'identificationModule': {'nctId': 'NCT01216995', 'acronym': 'ADVANCE', 'briefTitle': 'Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytori Therapeutics'}, 'officialTitle': 'A Phase II Trial of Safety and Efficacy of ADRCs Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction - The ADVANCE Study', 'orgStudyIdInfo': {'id': 'ADVANCE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dose A', 'description': 'Dose A', 'interventionNames': ['Biological: Dose A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Dose A', 'type': 'BIOLOGICAL', 'otherNames': ['Adipose-Derived Regenerative Cells'], 'description': 'ADRC Dose A', 'armGroupLabels': ['Dose A']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo Comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus University Medical Centrum', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '31202', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '02097', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Steven Kesten, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cytori Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytori Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}