This Phase I/II randomized clinical trial investigates the safety, feasibility, and early regenerative potential of intra-articular administration of mesenchymal stem cell (MSC)-derived secretome combined with Plasma Rich in Growth Factors (PRGF) in patients with knee osteoarthritis (KOA). The study aims to assess whether this cell-free, biologically enriched therapeutic combination can reduce pain, improve joint function, and promote cartilage repair.
Diagnosed with primary OA in one or both knees based on American College of Rheumatology criteria
Grade I and II Arthritis
Joint pain ≥ 20mm measured by visual analogue scale
Age ranges from 30-55 years of age
• Secondary OA due to trauma, infection, rheumatoid arthritis, congenital disease or other inflammatory disorders of the knee
Diagnosed with a systemic autoimmune disorder, immunodeficiency or coagulation disorder
Had history of malignancy
History of allergy or allergic constitution
Parallel
MSC-Derived Secretome
Biological/VaccineThe secretome will be collected from cultured MSCs under sterile, GMP-compliant conditions and concentrated to retain bioactive molecules. It will be injected into the affected knee under ultrasound guidance.
MSC-Derived Secretome + Autologous PRGF
Biological/VaccineMSC-derived secretome will be collected from mesenchymal stem cell cultures under sterile, GMP-compliant conditions. Autologous PRP will be prepared from the participant's own peripheral blood using a standardized single-spin centrifugation method and combined with 10% calcium chloride to activate growth factors. Both components will be mixed and administered into the affected joint under ultrasound guidance.
Change in Knee Pain (VAS Score) Change in WOMAC Score Adverse Events (Safety Monitoring)
Participants are evaluated for change in pain intensity using the Visual Analog Scale (VAS). Best outcome: pain score significantly reduced. If any Worst outcome: no change or increased pain. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be used to assess pain, stiffness, and physical function. Best outcome: improved total WOMAC score. Any local or systemic adverse events related to intra-articular administration of MSC secretome + PRP will be monitored and documented. Events will be categorized by type, severity, and relation to treatment.
Change in Cartilage Thickness (MRI) Synovial Fluid Biomarkers Patient Global Assessment
Evaluation of articular cartilage thickness, signal intensity, and subchondral bone integrity using MRI. Best outcome: increased or preserved cartilage thickness, reduced signal abnormalities. Quantification of inflammatory biomarkers (e.g., IL-1β, TNF-α, MMP-13) in synovial fluid to assess joint inflammation. Best outcome: significant reduction in pro-inflammatory marker levels post-treatment. Self-reported patient evaluation of symptom relief and joint mobility using a standardized global assessment scale. Best outcome: improved self-perceived joint health.
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University of the Punjab
Lead sponsor
Centre of Excellence in Molecular Biology (CEMB), University of the Punjab, Lahore.
Collaborator
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