PDF(Pubmed)
Abstract：
BACKGROUND: Knee osteoarthritis (KOA) presents a prevalent orthopedic condition causing substantial impairment in the quality of life and imposing a significant societal and economic burden. Mesenchymal stromal/stem cells (MSCs), known for their regenerative properties and immunomodulatory effects, have emerged as a promising therapeutic avenue in regenerative medicine. Despite MSCs\' therapeutic potential, their precise mechanisms of action in KOA remain underexplored.
METHODS: Conducted as a randomized, open-label clinical trial, 20 patients will be enrolled, with 10 in the intervention group and 10 in the control group. The primary focus will be to explore the molecular mechanisms associated with MSC therapy. Biomarkers and gene expressions related to cartilage metabolism, inflammation, immune modulation, and pain in the synovial fluid, blood, and tissue samples will be analyzed. Patients will undergo pre- and post-treatment evaluations using patient-reported outcome measures (PROMs) and comprehensive clinical assessments.
CONCLUSIONS: This is an exploratory study with the goal to provide comprehensive insights into the therapeutic effects of MSCs on a molecular level, potentially paving the way for optimized and more effective MSC-based therapies in the management of KOA, as well as furthering the development of novel treatment strategies.
BACKGROUND: ClinicalTrials.gov, NCT06078059. Registered on 5 October 2023.
METHODS: Conducted as a randomized, open-label clinical trial, 20 patients will be enrolled, with 10 in the intervention group and 10 in the control group. The primary focus will be to explore the molecular mechanisms associated with MSC therapy. Biomarkers and gene expressions related to cartilage metabolism, inflammation, immune modulation, and pain in the synovial fluid, blood, and tissue samples will be analyzed. Patients will undergo pre- and post-treatment evaluations using patient-reported outcome measures (PROMs) and comprehensive clinical assessments.
CONCLUSIONS: This is an exploratory study with the goal to provide comprehensive insights into the therapeutic effects of MSCs on a molecular level, potentially paving the way for optimized and more effective MSC-based therapies in the management of KOA, as well as furthering the development of novel treatment strategies.
BACKGROUND: ClinicalTrials.gov, NCT06078059. Registered on 5 October 2023.
摘要：
背景：膝骨性关节炎（KOA）是一种普遍存在的骨科疾病，导致生活质量严重受损，并造成重大的社会和经济负担。间充质基质/干细胞(MSCs),以其再生特性和免疫调节作用而闻名，已经成为再生医学中一种有前途的治疗途径。尽管MSCs具有治疗潜力，它们在KOA中的确切作用机制仍未得到充分探索。
方法：以随机，开放标签临床试验，将招募20名患者，干预组10例，对照组10例。主要重点将是探索与MSC治疗相关的分子机制。软骨代谢相关的生物标志物和基因表达,炎症,免疫调节，滑液疼痛,血,和组织样本将被分析。患者将使用患者报告的结果测量（PROM）和综合临床评估进行治疗前和治疗后评估。
结论：这是一项探索性研究，目的是在分子水平上全面了解MSCs的治疗效果。可能为KOA管理中优化和更有效的基于MSC的疗法铺平道路，以及进一步开发新的治疗策略。
背景：ClinicalTrials.gov，NCT06078059。2023年10月5日注册。
方法：以随机，开放标签临床试验，将招募20名患者，干预组10例，对照组10例。主要重点将是探索与MSC治疗相关的分子机制。软骨代谢相关的生物标志物和基因表达,炎症,免疫调节，滑液疼痛,血,和组织样本将被分析。患者将使用患者报告的结果测量（PROM）和综合临床评估进行治疗前和治疗后评估。
结论：这是一项探索性研究，目的是在分子水平上全面了解MSCs的治疗效果。可能为KOA管理中优化和更有效的基于MSC的疗法铺平道路，以及进一步开发新的治疗策略。
背景：ClinicalTrials.gov，NCT06078059。2023年10月5日注册。
