Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-01-01 @ 4:32 AM
Study NCT ID:
NCT00102128
Status:
TERMINATED
Last Update Posted:
2015-05-22
First Post:
2005-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Examine the Safety and Effectiveness of Implanted Skeletal Muscle Cells (Cells Removed From the Thigh Muscle) Into Scarred Areas of Heart Muscle After Heart Attack.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'whyStopped': 'DMC recommended stop', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2005-01-21', 'studyFirstSubmitQcDate': '2005-01-21', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Recovery of contractility within previously akinetic areas of the heart (areas without motion/contraction) that have received treatment (cells from the patient's thigh muscle or placebo), and change in left ventricular EF as assessed by echocardiography"}], 'secondaryOutcomes': [{'measure': 'Time-to-first major adverse cardiac event (cardiovascular related death, non-cardiovascular death, congestive heart failure, resuscitated sudden death, myocardial infarction (heart attack) and stroke.'}]}, 'conditionsModule': {'conditions': ['Ischemic Heart Failure', 'Ischemic Heart Disease', 'Ischemic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients recommended for coronary bypass surgery (preferably with cardiopulmonary support)\n* Ejection fraction ≥15% and ≤35%\n* Left ventricular myocardial infarction (MI - heart attack) ≥4 weeks prior to screening\n\nExclusion Criteria:\n\n* Need for a rapid surgical coronary revascularization\n* Need for any other related cardiosurgical measure during coronary surgery (e.g. mitral valve repair or valve replacement)\n* Patients with a left ventricular aneurysm who is a candidate for left ventricular aneurysmectomy or left ventricular reduction surgery; patient receiving left or biventricular (BiV) pacing therapy for heart failure (unless the patient has stabilized after 6 or more months of this therapy)\n* Cardiomyopathy presumed to be of non-ischemic origin'}, 'identificationModule': {'nctId': 'NCT00102128', 'briefTitle': 'Study to Examine the Safety and Effectiveness of Implanted Skeletal Muscle Cells (Cells Removed From the Thigh Muscle) Into Scarred Areas of Heart Muscle After Heart Attack.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure', 'orgStudyIdInfo': {'id': 'SMC00202'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Besançon', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Treviso', 'country': 'Italy', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'city': 'Udine', 'country': 'Italy', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Genzyme Corporation', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genzyme, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}