An Open-Label, Double-Treatment Group Study to Evaluate the Efficacy and Safety of Human Allogene… (NCT07542808) | Clinical Trial Compass
RecruitingPhase 2/3
An Open-Label, Double-Treatment Group Study to Evaluate the Efficacy and Safety of Human Allogeneic Bone-Marrow- Derived Mesenchymal Stromal Cell Product StromaForte Compared With Hyaluronic Acid for the Treatment of Knee Osteoarthritis
United Arab Emirates140 participantsStarted 2026-04-27
Plain-language summary
StromaForte injection for knee OA
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Joint pain during activity as assessed by the Visual Analogue Scale (VAS) of ≥ 40 at the time of screening
* Body Mass Index (BMI) between ≥ 18.5 to ≤ 35.0 kg/m2
Exclusion Criteria:
* 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.
* History of septic arthritis in the targeted knee.
* History of infectious or inflammatory joint disorders or suspected infective or inflammatory joint disease.
* Systemic or intra-articular injection of corticosteroids in any joint within 3 months before screening.
* Immunosuppression due to illness or medication including but not limited to high dose corticosteroids, calcineurin…
What they're measuring
1
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.
Timeframe: "From enrollment to the end of follow-up at 1 year