Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT04567732
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-03
First Post:
2020-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': '12 months', 'description': 'It is a 0 - 100 standardized questionnaire widely used for the evaluation of patients with knee osteoarthrosis. The questionnaire is made by three subscale: Pain (5 questions ranging from 0 - 20), Stiffness (2 questions ranging from 0 - 8) and Function (17 questions ranging from 0 - 68).'}], 'secondaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Baseline, 1, 3, 6, and 24 months', 'description': 'It is a 0 - 100 standardized questionnaire widely used for the evaluation of patients with knee osteoarthrosis. The questionnaire is made by three subscale: Pain (5 questions ranging from 0 - 20), Stiffness (2 questions ranging from 0 - 8) and Function (17 questions ranging from 0 - 68).'}, {'measure': 'Subjective International Knee Documentation Committee (IKDC - subjective score)', 'timeFrame': 'Baseline, 1, 3, 6, 12 and 24 months', 'description': 'Questionnaire is specific for knee pathologies. it is composed by three subscales: Symptoms, Sport Activities and Knee Function. (Total score 0-100)'}, {'measure': 'Objective International Knee Documentation Committee (IKDC-Objective Score)', 'timeFrame': 'Baseline, 1, 3, 6, 12 and 24 months', 'description': 'The presence of effusions and the degree of movement of the knee are evaluated, the worst value of one of these parameters determines the final value of the IKDC degree. There are four grades (A, B, C, D) which respectively identify a knee rated as normal, near normal, abnormal and severely abnormal;'}, {'measure': 'Tegner score', 'timeFrame': 'Before symptoms onset, at the baseline', 'description': 'describe and assess the sport activity with a score ranging from 0 to 10, where 0 means "inability" and 10 represent ability to perform "competitive sports".'}, {'measure': 'Patient Acceptable Symptom State (PASS)', 'timeFrame': 'Baseline, 1, 3, 6, 12 and 24 months', 'description': 'tool for assessing patient satisfaction in consideration of their current degree of pain, function and daily activity. The patient will evaluate his degree of satisfaction by answering a dichotomous closed question (yes / no).'}, {'measure': 'EuroQol Visual Analogue Scale (EQ-VAS)', 'timeFrame': 'Baseline, 1, 3, 6, 12 and 24 months', 'description': '0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health"'}, {'measure': 'Numeric Rating Scale (NRS) - Function', 'timeFrame': 'Baseline, 1, 3, 6, 12 and 24 months', 'description': 'the scale is to expect the patient to select the number that best describes their functional disability status, from 0 to 10. The higher the value indicated the higher the degree of disability will be.'}, {'measure': 'Numeric Rating Scale (NRS) - Pain', 'timeFrame': 'Baseline, 1, 3, 6, 12 and 24 months', 'description': 'the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 means worst possible pain.'}, {'measure': 'Kellgren-Lawrence score', 'timeFrame': 'baseline and 24 months', 'description': 'grade 0 to 4 for the assessment of the knee osteoarthritis grade, where 4 is the worst possible grade.'}, {'measure': 'Magnetic Resonance Imaging', 'timeFrame': 'baseline and 12 months', 'description': 'evaluation of the knee joint'}, {'measure': 'overall judgement on the treatment', 'timeFrame': '6, 12 and 24 months', 'description': 'The patient must indicate the degree of satisfaction with the treatment carried out at the end of the clinical trial'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arthrosis', 'Osteoarthrosis', 'Degenerative joint disease', 'Knee degenerative joint disease.', 'Bilateral', 'Fat tissue'], 'conditions': ['Bilateral Knee Osteoarthritis', 'Autologous Adipose Tissue']}, 'referencesModule': {'references': [{'pmid': '23051701', 'type': 'BACKGROUND', 'citation': 'Bianchi F, Maioli M, Leonardi E, Olivi E, Pasquinelli G, Valente S, Mendez AJ, Ricordi C, Raffaini M, Tremolada C, Ventura C. A new nonenzymatic method and device to obtain a fat tissue derivative highly enriched in pericyte-like elements by mild mechanical forces from human lipoaspirates. Cell Transplant. 2013;22(11):2063-77. doi: 10.3727/096368912X657855. Epub 2012 Oct 8.'}, {'pmid': '20444320', 'type': 'BACKGROUND', 'citation': 'Tremolada C, Palmieri G, Ricordi C. Adipocyte transplantation and stem cells: plastic surgery meets regenerative medicine. Cell Transplant. 2010;19(10):1217-23. doi: 10.3727/096368910X507187. Epub 2010 May 4.'}, {'pmid': '26240572', 'type': 'BACKGROUND', 'citation': 'Perdisa F, Gostynska N, Roffi A, Filardo G, Marcacci M, Kon E. Adipose-Derived Mesenchymal Stem Cells for the Treatment of Articular Cartilage: A Systematic Review on Preclinical and Clinical Evidence. Stem Cells Int. 2015;2015:597652. doi: 10.1155/2015/597652. Epub 2015 Jul 9.'}, {'pmid': '25108907', 'type': 'BACKGROUND', 'citation': 'Koh YG, Kwon OR, Kim YS, Choi YJ. Comparative outcomes of open-wedge high tibial osteotomy with platelet-rich plasma alone or in combination with mesenchymal stem cell treatment: a prospective study. Arthroscopy. 2014 Nov;30(11):1453-60. doi: 10.1016/j.arthro.2014.05.036. Epub 2014 Aug 6.'}, {'pmid': '25581339', 'type': 'BACKGROUND', 'citation': 'Bellamy N, Hochberg M, Tubach F, Martin-Mola E, Awada H, Bombardier C, Hajjaj-Hassouni N, Logeart I, Matucci-Cerinic M, van de Laar M, van der Heijde D, Dougados M. Development of multinational definitions of minimal clinically important improvement and patient acceptable symptomatic state in osteoarthritis. Arthritis Care Res (Hoboken). 2015 Jul;67(7):972-80. doi: 10.1002/acr.22538.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the radiological and clinical outcomes comparing two different treatments (Filtered Autologous Adipose Tissue versus Placebo) in patients affecting bilateral knee osteoarthritis.\n\nAfter be randomized, every patient will be treated in both legs, one leg with Adipose Tissue and the other one with Placebo.', 'detailedDescription': 'All patients who meet the inclusion criteria and giving written informed consent will be randomized.\n\nEvery patient will be treated with a single injection of Filtered Autologous Adipose Tissue in one knee and single injection of Placebo in the other, based on the randomization.\n\nAfter the treatment patients will be followed up to 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. bilateral degenerative chondropathy of the knees showing at least a grade 2-3 kellgren-lawrence classification (absence of severe osteoarthritis)\n2. An overall Pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index between a value of 9 and 19.\n3. Failure, intended as the persistence of symptomatology, after at least one conservative treatment cycle (pharmacological, physiotherapeutic or infiltrative treatment);\n4. Ability and informed consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;\n\nExclusion Criteria:\n\n1. Patients incapable of understanding and wanting;\n2. Diagnosis of leukaemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy;\n3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; infection with human immunodeficiency virus (HIV), viral hepatitis; chondrocalcinosis;\n4. Patients with uncontrolled diabetes mellitus;\n5. Patients with uncontrolled thyroid metabolic disorders;\n6. Patients who abuse alcoholic beverages, drugs or medicines;\n7. Patients with misalignment of the lower limbs above 10 degrees;\n8. Body Mass Index \\> 40;\n9. Pregnant or lactating state or intention to become pregnant during the period of participation in the study.\n10. Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening.\n11. Patients who have had knee surgery in the 12 months prior to screening.\n12. Patients with insufficient abdominal adipose tissue, assessed by the investigator"}, 'identificationModule': {'nctId': 'NCT04567732', 'briefTitle': 'Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo', 'orgStudyIdInfo': {'id': 'AdipoBil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Filtered Autologous Adipose Tissue', 'description': 'based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue', 'interventionNames': ['Combination Product: injection of Filtered Autologous Adipose Tissue']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'based on randomization one of the two knees will be treated with a single injection of Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'injection of Filtered Autologous Adipose Tissue', 'type': 'COMBINATION_PRODUCT', 'description': 'Single injection of Filtered Autologous Adipose Tissue', 'armGroupLabels': ['Filtered Autologous Adipose Tissue']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single injection of Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40124', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}