Safety and Efficacy of Pacental Cells Derived Extracellular Vesicles in Knee Osteoarthritis .
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Safety and efficacy of placental mesenchymal stromal cells-derived extracellular vesicles in knee osteoarthritis: a randomized, triple-blind, placebo-controlled clinical trial.
BMC Musculoskelet Disord . 2024 Oct 28;25(1):856.Fifty-eight knees from 29 patients with grade 2 or 3 bilateral knee osteoarthritis were randomized in a split-body design to receive a single injection of PMSCs-EVs (n=29) or normal saline (n=29). The primary outcome of interest was improvement in clinical symptoms assessed by VAS, WOMAC, and Lequesne scores. Secondary outcomes included changes in MRI findings such as cartilage volume, meniscal disintegrity, ACL integrity, and effusion-synovitis. Outcomes were evaluated at baseline, 2 months, and 6 months post-intervention. Overall, the results revealed no significant differences between the PMSCs-EVs and placebo groups in clinical symptoms or MRI findings. The study concluded that while PMSCs-EVs are safe, they do not provide additional therapeutic benefits compared to placebo.
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