This study is a randomized, double-blind, multicenter Phase II/III clinical trial designed to evaluate the effectiveness and safety of umbilical cord-derived mesenchymal stem cell (UC-MSC) secretome compared with sodium hyaluronate in patients with knee osteoarthritis. Knee osteoarthritis is a common degenerative joint disease that causes chronic pain and functional limitation. Participants will be randomly assigned to receive intra-articular injections of either UC-MSC-derived secretome or sodium hyaluronate. The study aims to assess improvements in knee pain, physical function, and overall clinical outcomes, as well as to evaluate the safety of the interventions over the study period.
Diagnosed with primary OA in one or both knees based on American College of Rheumatology (Clinical and Rheumatology criteria). If both knees have OA, the knee with the OA grade that falls within the inclusion criteria (grade 2-3) will be selected. If both knees meet the inclusion criteria, the knee with the highest grade and the one that is most uncomfortable will be chosen.
Males or females in the age range 40-70 years
Symptomatic knee OA (defined by pain at the affected joint for at least 3 months before inclusion and visual analog scale 40 - 70 mm on a 100 mm Visual Analog Scale (VAS).
Radiographic evidence of grade 2 to 3 osteoarthritis (OA) based on Kellgren and Lawrence radiographic criteria.
Participants who, based on physical examination and clinical history (anamnesis), are in the active or acute phase of cardiac, pulmonary, hematological, hepatic, renal, systemic autoimmune, immunodeficiency, or coagulation disorders that may interfere with the administration of the study drug (Secretome or Sodium Hyaluronate) will be excluded,
Diagnosed with a meniscal rupture based on clinical history (anamnesis) and physical examination. If the anamnesis and physical examination show symptoms and signs of a meniscal rupture, further evaluation will be performed using ultrasound (USG),
Participants with significant axial deviation, defined by valgus or varus deformity observed during physical examination, will be excluded,
Participants with other pathological lesions on knee X-rays from the screening examination will also be excluded,
Parallel
UC-MSC-Derived Secretome
Biological/VaccineUmbilical cord-derived mesenchymal stem cell secretome administered via intra-articular injection according to the study protocol.
Sodium Hyaluronate (Hyalein)
DrugSodium hyaluronate administered via intra-articular injection as an active comparator.
Change From Baseline in WOMAC Pain Subscale Score
Change from baseline in knee pain assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale.
Change From Baseline in WOMAC Total Score
Change from baseline in overall knee pain, stiffness, and physical function assessed using WOMAC total score.
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Universitas Sriwijaya
Lead sponsor
PT Bifarma Adiluhung
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
