Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT05777967
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of FF-31501 in Meniscus Tear Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-03-08', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lysholm score', 'timeFrame': 'Screening up to 52 weeks', 'description': 'It consists of items that measure: pain, instability, locking, swelling, limp, stair climbing, squatting, and need for support. Lowest and highest scores are 0 and 100 (better), respectively.'}], 'secondaryOutcomes': [{'measure': 'Arthroscopic assessment of the meniscus', 'timeFrame': 'Meniscus repair up to 52 weeks', 'description': 'The structure and function of the repaired meniscus will be assessed in terms of the presence, stability, and smoothness of the meniscus by arthroscopic imaging and MRI.'}, {'measure': 'Knee injury and osteoarthritis outcome score (KOOS)', 'timeFrame': 'Screening up to the Day before injection,4,12,24 and 52 weeks', 'description': 'The KOOS consists of five subscales; Pain, other symptoms, function in daily living (ADL), function in sport and recreation (Sport/Rec) and knee related quality of life (QOL). Lowest and highest scores are 0 and 100 (better), respectively.'}, {'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': 'Screening up to the Day before injection,4,12,24 and 52 weeks', 'description': "NRS consists of an 11-point scale to evaluate current knee pain where no pain is indicated by '0', and the worst pain imaginable by '10'."}, {'measure': 'Kellgren Lawrence', 'timeFrame': 'Screening up to 24 and 52 weeks', 'description': 'The Kellgren and Lawrence system is a common method of classifying the severity of osteoarthritis (OA) using five grades.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meniscus Injury']}, 'descriptionModule': {'briefSummary': 'A single-arm, multi-center study to verify that knee joint function at 52 weeks after injection of FF-31501 is better than at screening in patients with meniscus tear who are eligible for meniscectomy .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with suspected meniscal flap tear\n2. Patients with knee pain\n3. Patients with one or more of the following symptoms\n\n * Feeling stuck in the kneeć»Instability of the knee\n * Knee range of motion impairment\n * Knee joint edema\n4. Other\n\nExclusion Criteria:\n\n1. Patients with poor knee alignment\n2. Patients who underwent meniscus surgery or platelet rich plasma therapy\n3. Patients with or history of knee ligament injury\n4. Diabetic patients with poor glycemic control\n5. Patients with the following complications and poor general condition\n\n * Severe cardiovascular disease\n * Severe liver disease\n * Severe renal dysfunction\n * Severe anemiać»uncontrolled mental illness\n * Other diseases for which sudden change or worsening of symptoms can be expected during study participation\n6. Patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period\n7. Other'}, 'identificationModule': {'nctId': 'NCT05777967', 'briefTitle': 'Efficacy and Safety of FF-31501 in Meniscus Tear Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'FUJIFILM Toyama Chemical Co., Ltd.'}, 'officialTitle': 'A Phase 3 Single-arm Multicenter Study of FF-31501 in Meniscus Tear Patients', 'orgStudyIdInfo': {'id': 'FF31501JP301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'interventionNames': ['Biological: human autologous synovial stem cells']}], 'interventions': [{'name': 'human autologous synovial stem cells', 'type': 'BIOLOGICAL', 'description': 'A single injection of 1.5 to 9.0 x 10\\^7 human autologous synovial stem cells under arthroscopy', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'facility': 'Medical corporation keimeikai Juko Osu hospital', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Wakamatsu Hospital of the University of OccupationalOC and Environmental Health', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Mie', 'country': 'Japan', 'facility': 'Mie Prefectural General Medical Center', 'geoPoint': {'lat': 32.96667, 'lon': 131.58333}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical and Dental University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FUJIFILM Toyama Chemical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}