Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT00426868
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2007-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-27', 'studyFirstSubmitDate': '2007-01-23', 'studyFirstSubmitQcDate': '2007-01-24', 'lastUpdatePostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)', 'timeFrame': 'Up to 36 months'}], 'secondaryOutcomes': [{'measure': 'Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography', 'timeFrame': 'Up to 36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ADRC', 'Stem Cells', 'chronic ischemia', 'heart disease', 'coronary artery disease', 'inducible reversible ischemia'], 'conditions': ['Ischemic Heart Disease', 'Coronary Arteriosclerosis', 'Cardiovascular Disease', 'Coronary Disease', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '24952864', 'type': 'DERIVED', 'citation': 'Perin EC, Sanz-Ruiz R, Sanchez PL, Lasso J, Perez-Cano R, Alonso-Farto JC, Perez-David E, Fernandez-Santos ME, Serruys PW, Duckers HJ, Kastrup J, Chamuleau S, Zheng Y, Silva GV, Willerson JT, Fernandez-Aviles F. Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial. Am Heart J. 2014 Jul;168(1):88-95.e2. doi: 10.1016/j.ahj.2014.03.022. Epub 2014 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish safety and feasibility of utilizing Adipose Derived Stem \\& Regenerative Cells (ADRCs) in patients who have areas of myocardium that are not revascularizable and have demonstrated reversible ischemia.', 'detailedDescription': 'Subjects who have coronary artery disease that cannot be revascularized and demonstrate reversible ischemia in the area supplied by the non-revascularizable vessel(s) will be evaluated for eligibility in this study. Eligible subjects will undergo standard pre-operative testing after admission to the hospital, and then will undergo liposuction under anesthesia, after which ADRCs will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRCs or placebo.\n\nThe outcomes of this trial will be based on assessment of primary and secondary endpoints at 6 months post index procedure. Long Term Follow-up will be conducted at 12, 18, 24 and 36 months after the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Able to provide written informed consent\n* Males or females 20 to 75 years of age, inclusive\n* Coronary artery disease not amenable to any type of revascularization procedure (percutaneous or surgical) in the target area\n* Hemodynamic stability\n* Ability to undergo liposuction\n* Ability to walk on a treadmill\n* Negative urine pregnancy test (females only).\n\nKey Exclusion Criteria:\n\n* Unstable angina\n* Serum creatinine \\>2.5 mg/dL\n* Planned or scheduled staged treatment of CAD or other interventional or surgical procedures\n* Cardiogenic shock\n* History of resuscitated sudden cardiac death; or symptomatic or sustained ventricular fibrillation or ventricular tachycardia.\n* Vascular anatomy that precludes cardiac catheterization\n* Peripheral artery disease that precludes insertion of an 8 Fr sheath\n* Severe valvular disease\n* Pregnant or nursing females\n* Known and relevant allergies or sensitivities\n* Life expectancy \\<1 year\n* Participation in any other clinical research study that has not reached its primary endpoint or otherwise would interfere with the subject's participation in this study\n* Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study."}, 'identificationModule': {'nctId': 'NCT00426868', 'briefTitle': 'A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytori Therapeutics'}, 'officialTitle': 'A Randomized Clinical Trial of adiPose-deRived stEm & Regenerative Cells In the Treatment of Patients With Non revaScularizable ischEmic Myocardium - The PRECISE Trial', 'orgStudyIdInfo': {'id': 'PRECISE-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Other: Direct injection of ADRCs into the Left Ventricle']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Direct injection of placebo into the Left Ventricle']}], 'interventions': [{'name': 'Direct injection of ADRCs into the Left Ventricle', 'type': 'OTHER', 'description': 'Dose escalation', 'armGroupLabels': ['Treatment']}, {'name': 'Direct injection of placebo into the Left Ventricle', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus University Medical Centrum, Thorax Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University of Utrecht Medical Center', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Alexander M Milstein, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cytori Therapeutics, Inc'}, {'name': 'Francisco J Fernández-Avilés, MD, PhD, FACC, FESC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital G.U. Gregorio Marañón'}, {'name': 'Emerson C Perin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Heart Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytori Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}