Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-01-21 @ 9:31 AM
Study NCT ID:
NCT06893250
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-25
First Post:
2024-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orthobiologic Treatment for Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2024-10-02', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KOOS (The Knee injury and Osteoarthritis Outcome Score)', 'timeFrame': 'Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)', 'description': 'KOOS score filled out by the patient, from 0-100 where a higher score indicates worse outcomes.'}, {'measure': 'WOMAC score (Western Ontario og McMaster Universities Osteoarthritis Index)', 'timeFrame': 'Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)', 'description': 'Clinical outcome scores (WOMAC) filled out by the patient. Scale from 0-96 in total (0-4 on each question, added together). A higher score indicates a worse score.'}, {'measure': 'VAS (Visual analogue scale)', 'timeFrame': 'Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)', 'description': 'Pain score (VAS) from 0-10 where a higher score indicates worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Radiological findings after treatment', 'timeFrame': 'At inclusion and 2 years after intervention.', 'description': 'Cartilage status on MRI (magnetic resonance imaging) 2 years after intervention as compared with at time of inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'knee', 'platelet rich plasma', 'adipose tissue'], 'conditions': ['Osteoarthritis Knee']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized clinical trial is to compare treatment for osteoarthritis in the knee using platelet rich plasma (PRP) or adipose stem cells (ADS). The main questions it aims to answer are:\n\n* Will the patients clinically benefit from the treatment, and if so, which treatment is better?\n* Will there be radiological findings to support this? Participants will be randomized into one of four groups: PRP, ADS, PRP + ADS or placebo treatment (saline) and will be examined and get an X-ray and MRI of the knee taken at inclusion and after 1 and 2 years.', 'detailedDescription': 'Patients will be randomized into one of four treatment groups and then be followed up at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after intervention. They will fill out scores and be clinically evaluated, as well as radiologically examined at inclusion and at the final check up (x-ray and MRI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic osteoarthritis in the knee grade I-III using the Kellgren-Lawrance Grading Scale\n* Age 40-70 years\n* Minimum VAS 3\n* No use of NSAIDs or steroids the last 14 days\n* No injections of hyaluronic acid the last three months\n* Varus/valgus deformity \\<5 degrees as evaluated on x-ray imaging\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Cancer\n* Other etiologies of knee pain (refered pain, pain from the back, dislocated meniscus on MRI, osteoarthritis grade IV using the Kellgren-Lawrance Grading Scale)\n* Previous knee surgery on the affected knee\n* Secondary osteoarthritis in the knee\n* Previous infection in the knee\n* Other diseases (rheumatoid arthritis, diabetes, systemic diseases or corticosteroid-demaning disease)\n* Patients with a high risk of deep vein thrombosis\n* Patients who cannot cooperate/are low compliance (psychiatric disease) or has contraindications for MRI'}, 'identificationModule': {'nctId': 'NCT06893250', 'briefTitle': 'Orthobiologic Treatment for Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of North Norway'}, 'officialTitle': 'Orthobiologic Treatment for Knee Osteoarthritis (Ortobiologisk Behandling av Kneleddsartrose)', 'orgStudyIdInfo': {'id': '376638'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet rich plasma (PRP)', 'description': 'Plasma taken from the patient is centrifuged and isolated before it is injected into the patients knee.', 'interventionNames': ['Biological: PRP injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adipose tissue stem cells', 'description': 'Adipose tissue is taken from the patients abdominal subcutaneous fat tissue and is injected into the knee.', 'interventionNames': ['Biological: ADSTEM Inj. (Adult human mesenchymal stem cells)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet rich plasma + adipose tissue stem cells', 'description': 'A combination of platelet rich plasma and adipose tissue stem cells are taken from the patient and injected into the patients knee.', 'interventionNames': ['Biological: Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (saline)', 'description': 'Saline (NaCl) is injected into the patients knee.', 'interventionNames': ['Biological: Saline (NaCl 0,9 %) (placebo)']}], 'interventions': [{'name': 'PRP injection', 'type': 'BIOLOGICAL', 'otherNames': ['Platelet rich plasma', 'PRP'], 'description': 'Platelet rich plasma, blood from the patient that is centrifuged.', 'armGroupLabels': ['Platelet rich plasma (PRP)']}, {'name': 'ADSTEM Inj. (Adult human mesenchymal stem cells)', 'type': 'BIOLOGICAL', 'otherNames': ['Mesenchymal stem cells', 'Adipose tissue stem cells'], 'description': 'Adipose tissue stem cells, from abdominal fat.', 'armGroupLabels': ['Adipose tissue stem cells']}, {'name': 'Injection', 'type': 'BIOLOGICAL', 'otherNames': ['PRP', 'Adipose tissue stem cells'], 'description': 'PRP + adipose tissue stem cells', 'armGroupLabels': ['Platelet rich plasma + adipose tissue stem cells']}, {'name': 'Saline (NaCl 0,9 %) (placebo)', 'type': 'BIOLOGICAL', 'otherNames': ['placebo', 'NaCl', 'saline'], 'description': 'Sterile saline injection.', 'armGroupLabels': ['Placebo (saline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9038', 'city': 'Tromsø', 'state': 'Tromsø', 'country': 'Norway', 'facility': 'University Hospital in Northern Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only main scientists in the project will have access to IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of North Norway', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}