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

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

StromaForte injection for knee OA

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 inhibitors, anti-TNF, anti-IL-6, anti-p40, biologics and prednisone and/or equivalent over 5 mg/day.
• Planned orthopaedic surgery on lower limbs within the next 12 months
• Active or suspected infection.
• History of malignancy in the past 2.5 years, except in-situ cancers treated by local excision with curative intent.
• Severe bleeding diathesis.
• Participation in another clinical trial including treatment with a different investigational product within 30 days prior to inclusion in this study.
• Pregnancy or breastfeeding.
• Unwilling or for medical reason not recommended to pause anticoagulant medications prior to procedure, as judged by prescribing doctor.
• Known diagnosis of HIV-1, HIV-2, Hepatitis A, Hepatitis B, Hepatitis C, HTLV-I/II, or Syphilis, or other acute or chronic infectious disease.
• Pulmonary embolism, deep vein thrombosis or other serious embolic disease within the past 4 months.
• Known allergies or hypersensitivity to DMSO, human serum albumin, heparin or PlasmaLyte.
• History or current evidence of any condition, therapy, laboratory abn ormality, or other circumstance that might confound the results of the study or interfere with the study participant's participation for the full duration of the study.
• Cognitive or language barriers that prohibit obtaining informed consent, questionnaires or any study elements.
• Recipient of any stem cell therapy within the previous 12 months