Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-27 @ 11:20 AM
Study NCT ID:
NCT02270905
Status:
SUSPENDED
Last Update Posted:
2018-11-20
First Post:
2014-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2014-10-17', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain relief as assessed by Visual Analog Scale (VAS)', 'timeFrame': '24 months', 'description': 'Change in VAS Pain score from baseline'}], 'secondaryOutcomes': [{'measure': 'Knee functional improvement as assessed by patient questionnaires', 'timeFrame': '24 months', 'description': 'IKDC, Lysholm and KOOS score change over time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['meniscus', 'meniscectomy', 'decellularised', 'xenograft'], 'conditions': ['Knee Injuries']}, 'descriptionModule': {'briefSummary': 'The safety and performance of dCELL® Meniscus will be evaluated in 60 patients after partial replacement of the native medial or lateral meniscus with the investigational product.', 'detailedDescription': "The dCELL® Meniscus is a novel decellularised porcine xenograft which is processed using a patented variation of Tissue Regenix's platform dCELL® technology to render it biocompatible and free from cellular material, leaving behind an acellular biological scaffold that is safe for human implantation whilst preserving the biomechanical properties. It is indicated as a biological implant to replace parts of the native meniscus in the knee for patients who present with chronic pain following failed previous meniscus repair or partial meniscectomy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with chronic pain following failed previous meniscus repair or partial meniscectomy\n* Must be a stable, well aligned knee with ligament laxity of Grade II or less\n* Osteoarthritis \\<grade 3 on the Kellgren Lawrence scale\n* Patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol\n\nExclusion Criteria:\n\n* Body Mass Index (BMI) greater than 35 kg/m2\n* Treatment with any investigational drug or device within two months prior to screening\n* Patients presenting with abnormal degenerative osteoarthritis of the joint\n* Patients with a current ligament injury requiring immediate surgery or have had ligament surgery in the previous three months\n* Patients using anticoagulants\n* Patients on current immuno-suppressive or radiation therapy or having received such therapies within six months of screening\n* Patients with diabetes or cardiovascular disease which precludes elective surgery\n* Patients with documented renal disease or metabolic bone disease'}, 'identificationModule': {'nctId': 'NCT02270905', 'briefTitle': 'Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tissue Regenix Ltd'}, 'officialTitle': 'An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus', 'orgStudyIdInfo': {'id': 'TRG-D02-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dCELL® Meniscus', 'interventionNames': ['Device: dCELL® Meniscus']}], 'interventions': [{'name': 'dCELL® Meniscus', 'type': 'DEVICE', 'description': 'decellularised porcine xenograft', 'armGroupLabels': ['dCELL® Meniscus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bialystok', 'country': 'Poland', 'facility': '"Ortotrauma" Spółka Z Ograniczoną', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Oswestry', 'state': 'Shropshire', 'country': 'United Kingdom', 'facility': 'The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS FOUNDATION TRUST', 'geoPoint': {'lat': 52.86195, 'lon': -3.05497}}, {'city': 'Uxbridge', 'country': 'United Kingdom', 'facility': 'The Hillingdon Hospitals NHS FOUNDATION TRUST', 'geoPoint': {'lat': 51.5489, 'lon': -0.48211}}, {'city': 'York', 'country': 'United Kingdom', 'facility': 'Clifton Park Hospital', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}], 'overallOfficials': [{'name': 'David Houlihan-Burne', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hillingdon Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tissue Regenix Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}