Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 5:30 PM
Study NCT ID:
NCT05933434
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blinded (participant and investigator)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional group\n\n* Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells Placebo group\n* Single intraarticular knee injection with saline'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-08', 'studyFirstSubmitDate': '2023-06-05', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observation (change) of adverse events', 'timeFrame': 'Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years', 'description': 'Pain Diary first 30 days after treatment, any reported adverse events after treatment'}, {'measure': 'Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline', 'timeFrame': 'Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years', 'description': '(questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms))'}], 'secondaryOutcomes': [{'measure': 'Change in pain from baseline', 'timeFrame': 'Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years', 'description': 'Numeric Rating Scale (NRS)'}, {'measure': 'Observation (change) of cartilage regeneration compared to baseline', 'timeFrame': 'Baseline, 3 months, 12 months, 24 months', 'description': 'MRI Osteoarthritis Knee Score'}, {'measure': 'Observation (change) of quantitative cartilage regeneration compared to baseline', 'timeFrame': 'Baseline, 3 months, 12 months, 24 months', 'description': 'Quantitative MRI (unit: stress and strain and volumen cartilage)'}, {'measure': 'Improvement (change) during clinical examination with range of motion compared to baseline', 'timeFrame': 'Baseline, 3 months, 12 months, 24 months', 'description': 'Range of motion (unit: degrees)'}, {'measure': 'Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline', 'timeFrame': 'Baseline, 3 months, 12 months, 24 months', 'description': 'Effusion tests (swelling) (unit: effusion (YES/NO))'}, {'measure': 'Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline', 'timeFrame': 'Baseline, 3 months, 12 months, 24 months', 'description': 'Measure knee diameter (unit: cm)'}, {'measure': 'Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline', 'timeFrame': 'Baseline, 3 months, 12 months, 24 months', 'description': 'Measure quadriceps muscle (unit: cm)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allogenic adipose derived mesenchymal stem cells', 'adipose derived mesenchymal stem cells', 'mesenchymal stem cells', 'stem cells'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This phase I and II double blinded randomized clinical controlled trial investigates the safety and efficacy of intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC), in patients suffering from mild-moderate knee osteoarthritis compared to placebo injection with saline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)\n* Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.\n* Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity\n* Medial, lateral or dual compartment OA as determined above\n* BMI \\<35\n* Danish speaker\n* Patients must be legally competent and must be able to sign the written consent\n\nExclusion Criteria:\n\n* Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)\n* Intraarticular tumor, infection or fracture\n* Pregnancy and breast feeding\n* Cognitive impairment\n* Treatment with cytostatic drugs\n* Previous intraarticular knee injection in the past 3 mo.\n* Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity(\\>BMI 35)\n* Previous ligament reconstruction\n* Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection)\n* Diabetes mellitus type 1 and 2\n* Knee instability on physical examination\n* History of allergy to antibiotics\n* Concomitant severe infection, malignant tumor, coagulation diseases or uncontrolled or unmanaged systemic disease\n* Presence of other types of inflammatory arthritis'}, 'identificationModule': {'nctId': 'NCT05933434', 'acronym': 'STEMJOINT', 'briefTitle': 'Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study', 'orgStudyIdInfo': {'id': 'STEMJOINT01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC)\n\n20 million AD-MSC in 10 mL saline', 'interventionNames': ['Biological: Allogenic adipose derived mesenchymal stem cells (AD-MSC)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Single intraarticular knee injection with saline alone\n\n10 mL saline', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Allogenic adipose derived mesenchymal stem cells (AD-MSC)', 'type': 'BIOLOGICAL', 'description': 'Laboratory isolated, cultivated and cryopreserved allogenic adipose derived mesenchymal stem cells (AD-MSC) from health donors undergoing cometic plastic surgery will be thawed on the injection day and formulated in 10 mL saline. The AD-MSCs will then be intraarticular injected using ultrasonic guidance.', 'armGroupLabels': ['Intervention']}, {'name': 'Saline', 'type': 'OTHER', 'description': '10 mL saline will be intraarticular injected using ultrasonic guidance.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Rasmus Aabling, MD', 'role': 'CONTACT', 'email': 'rasaab@clin.au.dk', 'phone': '+45 78450000'}], 'facility': 'Aarhus University', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'centralContacts': [{'name': 'Rasmus Aabling, MD', 'role': 'CONTACT', 'email': 'rasaab@clin.au.dk', 'phone': '+4528496767'}, {'name': 'Michael Pedersen, Professor', 'role': 'CONTACT', 'email': 'michael@clin.au.dk'}], 'overallOfficials': [{'name': 'Rasmus Aabling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Rasmus Roost Aabling', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}