Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-28 @ 12:26 AM
Study NCT ID:
NCT06171204
Status:
RECRUITING
Last Update Posted:
2024-11-08
First Post:
2023-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Stromal Vascular Fraction for Knee Arthrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2023-12-06', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the safety of SVF injections after cryo preservation', 'timeFrame': '1 year', 'description': 'The patient will complete the KOOS questionnaire (Knee Injury and Osteoarthritis Outcome Score) on several timepoints.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Arthrosis']}, 'descriptionModule': {'briefSummary': "A trial to investigate the safety and efficacy of SVF for the treatment of knee arthrosis.\n\nPatients will undergo a single liposuction to obtain the SVF. The SVF will then be isolated and frozen in our laboratory. The SVF will then be injected up to 2 times into the fat pad of the patient's knee.", 'detailedDescription': 'Stromal Vascular Fraction (SVF) from adipose tissue is increasingly being used in the clinic for a variety of conditions (skin disorders, joint pain, etc.). SVF is a collective term for cells that can be obtained from liposuction fat. These cells can be separated from the fat by mechanical processing of the liposuction fat combined with an additional centrifugation.\n\nDespite the fact that enough SVF can be isolated after such a liposuction for multiple treatments (\\>3), our research group has found a way to safely freeze SVF without significant loss of SVF cells. In this way, a patient would only have to undergo one liposuction and associated anesthesia to be able to obtain multiple SVF treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Legal capacity\n* Osteochondral lesions\n* Inflammatory complaints\n* (Peri)tendinitis or tendinopathies and ligamentous injuries\n* Impingement complaints\n* Arthrofibrosis\n* Anterior knee pain'}, 'identificationModule': {'nctId': 'NCT06171204', 'briefTitle': 'The Use of Stromal Vascular Fraction for Knee Arthrosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Gebruik Van Stromale Vasculaire Fractie Uit Vetweefsel Na Invriezing Voor Knie Arthrose', 'orgStudyIdInfo': {'id': 'BC-07772'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Injection of SVF in fat pad of the knee', 'type': 'PROCEDURE', 'description': 'Knee fat pad injection with SVF at orthopaedics/physical medicine outpatient clinic'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'UZ GENT', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Bernard Depypere, MD', 'role': 'CONTACT', 'email': 'bernard.depypere@ugent.be', 'phone': '093325730'}, {'name': 'Jessie De Kinder', 'role': 'CONTACT', 'email': 'jessie.dekinder@uzgent.be', 'phone': '093321373'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}