Status:
UNKNOWN
Adipose-derived MSCs After Enzymatic Digestion vs. Mechanically Fragmented Fat Transfer in Knee Osteoarthritis Treatment
Lead Sponsor:
Medical University of Warsaw
Conditions:
Knee Osteoarthritis
Chondropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ther...
Detailed Description
Based on the calculation of the sample size using power analysis of the test, investigators plan to include 100 adults with primary knee osteoarthritis in this study. The patients will undergo lipoasp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04675359
Start Date
July 1 2021
End Date
December 1 2023
Last Update
January 8 2021
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