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Clinical Efficacy and Safety of the Intra-articular Injection of Autologous Adipose-Derived Mesenchymal Stem Cells for Knee Osteoarthritis: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial by Kang-Il Kim; Myung Chul Lee; Ju Hong Lee; Young-Wan Moon; Woo-Suk Lee; Han-Jun Lee; Sun-Chul Hwang; Yong In; Oog-Jin Shon; Ki-Cheor Bae; Sang-Jun Song; Kwan Kyu Park; Jun-Ho Kim is a Medicine article available to read on EtoBox.

What is Clinical Efficacy and Safety of the Intra-articular Injection of Autologous Adipose-Derived Mesenchymal Stem Cells for Knee Osteoarthritis: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial about?

## Background: Intra-articular injection of autologous culture-expanded adipose-derived mesenchymal stem cells (ADMSCs) has introduced a promising treatment option for knee osteoarthritis. Although the clinical efficacy and safety of ADMSCs have been reported, the treatment remains controversial owing to the small sample sizes and heterogeneous osteoarthritis grades in previous studies. ## Purpose: To assess the efficacy and safety of intra-articular injection of ADMSCs as compared with placebo in alleviating pain and improving functional capacity in a large sample of patients with knee osteoarthritis of Kellgren-Lawrence (K-L) grade 3. ## Study Design: Randomized controlled trial; Level of evidence, 1. ## Methods: This phase III multicenter clinical trial was a double-blind randomized controlled study that included 261 patients with K-L grade 3 symptomatic knee osteoarthritis who were administered a single injection of autologous culture-expanded ADMSCs or placebo. Clinical data were assessed at baseline and at 3 and 6 months after the injection. The primary endpoints were improvements in 100-mm visual analog scale (VAS) for pain and Western Ontario and McMaster Universities Osteo

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Author

Kang-Il Kim; Myung Chul Lee; Ju Hong Lee; Young-Wan Moon; Woo-Suk Lee; Han-Jun Lee; Sun-Chul Hwang; Yong In; Oog-Jin Shon; Ki-Cheor Bae; Sang-Jun Song; Kwan Kyu Park; Jun-Ho Kim

Publisher

SAGE Publications

Published

2023

Language

EN

Field

Medicine (Health Sciences)