Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT01066702
Status:
TERMINATED
Last Update Posted:
2019-03-29
First Post:
2010-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Confirmatory Study of NeoCart in Knee Cartilage Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054544', 'term': 'Arthroplasty, Subchondral'}], 'ancestors': [{'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'whyStopped': 'company dissolution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2010-02-08', 'studyFirstSubmitQcDate': '2010-02-09', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score)', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Repair cartilage structure as measured by magnetic resonance imaging (MRI)', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Articular Cartilage Defects in the Knee Joint']}, 'referencesModule': {'references': [{'pmid': '22637204', 'type': 'BACKGROUND', 'citation': 'Crawford DC, DeBerardino TM, Williams RJ 3rd. NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: an FDA phase-II prospective, randomized clinical trial after two years. J Bone Joint Surg Am. 2012 Jun 6;94(11):979-89. doi: 10.2106/JBJS.K.00533.'}, {'pmid': '19448048', 'type': 'BACKGROUND', 'citation': 'Crawford DC, Heveran CM, Cannon WD Jr, Foo LF, Potter HG. An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur: prospective clinical safety trial at 2 years. Am J Sports Med. 2009 Jul;37(7):1334-43. doi: 10.1177/0363546509333011. Epub 2009 May 15.'}], 'seeAlsoLinks': [{'url': 'http://www.histogenics.com', 'label': 'Histogenics WebSite'}]}, 'descriptionModule': {'briefSummary': 'This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* greater than 18 years old\n* symptomatic articular cartilage lesion of the femur and/or trochlea\n\nExclusion Criteria:\n\n* prior surgical intervention other than debridement\n* arthritis\n* clinically significant or symptomatic vascular or neurologic disorder of the lower extremities'}, 'identificationModule': {'nctId': 'NCT01066702', 'briefTitle': 'Confirmatory Study of NeoCart in Knee Cartilage Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Histogenics Corporation'}, 'officialTitle': 'A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee', 'orgStudyIdInfo': {'id': '8-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NeoCart', 'description': 'Autologous cartilagenous tissue implant', 'interventionNames': ['Biological: NeoCart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Microfracture', 'description': 'surgical intervention', 'interventionNames': ['Procedure: Microfracture']}], 'interventions': [{'name': 'NeoCart', 'type': 'BIOLOGICAL', 'description': 'implantation of an cartilagenous tissue implant derived from the patients own cells.', 'armGroupLabels': ['NeoCart']}, {'name': 'Microfracture', 'type': 'PROCEDURE', 'description': 'holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.', 'armGroupLabels': ['Microfracture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Orthopaedic Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Grossmont Orthopedic Medical Group', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI)', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Mission Bay Orthopaedic Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91405', 'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Orthopedic Research and Education', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}, {'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado University Boulder', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80111', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Steadman Hawkins Clinic - Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Shrock Clinical Research', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32822', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Jewett Orthopaedic Clinic', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Optim Healthcare', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'St. Lukes Medical Center', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46143', 'city': 'Greenwood', 'state': 'Indiana', 'country': 'United States', 'facility': 'OrthoIndy', 'geoPoint': {'lat': 39.61366, 'lon': -86.10665}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Sports Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Orthopaedic Associates', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '02467', 'city': 'West Roxbury', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Vanguard Medical Associates', 'geoPoint': {'lat': 42.27926, 'lon': -71.1495}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55431', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'TRIA Orthopaedic Center', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '59718', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'Alpine Orthopedics & Sports Medicine', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Sports Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University - Department of Sports Medicine', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78216', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The San Antonio Orthopaedic Group (TSAOG)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'The Orthopedic Specialty Hospital', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Simon Fraser Orthopaedic Fund', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Fowler Kennedy Sports Medicine Clinic', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Andrea Belschner', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Histogenics Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Histogenics Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}