StromaForte injection for knee OA
Willing and able to provide written informed consent and comply with all procedures required by the protocol.
Aged ≥ 18 years at the time of signing the informed consent form.
Diagnosed with knee osteoarthritis (OA) based on the criteria established by the American College of Rheumatology, confirmed through radiological images no older than three months.
Grade I to IV osteoarthritis on the Kellgren-Lawrence radiological classification scale.
Unwilling or unable to perform any of the assessments required by the protocol.
Mechanically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear.
Varus or valgus malalignment >5 degrees as measured by 4-foot standing antero-posterior radiographs.
History of subtotal medial or lateral meniscectomy performed less than 9 months ago.
Parallel
Mesenchymal Stem Cells (MSC)
Other interventionStromaForte
Hyaluronic Acid (HA)
Other interventionHyaluronic Acid
To show that StromaForte single dose treatment provides superior pain reduction from baseline to 6 months post-injection compared to hyaluronic acid single dose treatment.
Change from baseline in subjective pain during activity assessment according to the Visual Analogue Scale (VAS) questionnaire at 6 months ±30 days post-injection.
To evaluate the effect of StromaForte single dose treatment on pain reduction from baseline to 3 months and 12 months post-injection, compared to hyaluronic acid single dose treatment.
Change from baseline in subjective pain during activity assessment according to the Visual Analogue Scale (VAS) questionnaire at 3 months ±30 days and 12 months ±30 days post-injection.
To evaluate the effect of StromaForte single dose treatment on improvement of the patient's functional ability at 3 months, 6 months and 12months post-injection, compared to hyaluronic acid single dose treatment.
Change in functional ability using the Knee injury and Osteoarthritis Outcome Score (KOOS) scores from baseline to 3 months ±30 days, 6 months ±30 days and 12 months±30 days post-injection.
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