Knee Osteoarthritis Clinical Trial
Official title:
Comparison of the Treatment Results of Knee Osteoarthritis Using Adipose Tissue Mesenchymal Stromal Cells Derived Through Enzymatic Digestion and Mechanically Fragmented Adipose Tissue
The aim of the study is to compare the clinical effects of treatment of knee osteoarthritis using adipose tissue mesenchymal stromal cells obtained by an enzymatic method with the outcomes of the therapy with the mechanically fragmented adipose tissue. Identification and functional analysis of the regenerative capacity of MSCs derived from the adipose tissue depending on three variables (body weight, sex and age) will help to develop a targeted therapy for different groups of patients and will determine the effectiveness of both methods of treatment. An attempt was made to identify the groups of patients with the greatest regeneration potential of the adipose tissue, and thus indicate those with the most probable improvement of the joint condition.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults with symptomatic gonarthrosis diagnosed based on the X-ray, MRI and clinical examination, previously unsuccessfully treated (rehabilitation, NSAIDs, hyaluronic acid, platelet-rich plasma) - Primary knee osteoarthritis - Willingness and consent to participate in the study - Readiness to attend control visits Exclusion Criteria: - Failure to meet the inclusion criteria - Active chronic infection - Metal implant made of a ferromagnetic material that will exclude the patient from magnetic resonance imaging - Use of anticoagulants - General and intra-articular use of steroids during the last year - Pregnancy, breastfeeding - Any autoimmune and rheumatic disease, or conditions that influence the accuracy of test results - Taking drugs or cytostatic medications in the last 30 days - Mental disorders, alcohol and drug addiction |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Medical University of Warsaw |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in patients reported outcome measures - Knee Injury and Osteoarthritis Outcome Score (KOOS) | The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved. |
1,3,6 and 12 months after procedure | |
Primary | Changes in flexibility of the knee joint | Range of motion assessment by goniometer measurements | 1,3,6, and 12 months after procedure | |
Secondary | Changes in X-ray imaging of the knee joint in a standing position (AP view) | Articular cartilage volume evaluation by joint gap measurements | 6 months and 1 year after procedure | |
Secondary | Changes in MRI with T-2 Mapping of the knee cartilage | Articular cartilage quality evaluation in T-2 Mapping | 6 months and 1 year after procedure |
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