Richardson James B, Wright Karina T, Wales Johanna, Kuiper Jan Herman, McCarthy Helen S, Gallacher Peter, Harrison Paul E, Roberts Sally
Robert Jones & Agnes Hunt Orthopaedic Hospital, Oswestry, Shropshire, SY10 7AG, UK.
Institute for Science & Technology in Medicine, Keele University, Keele, Staffordshire, ST5 5BG, UK.
Regen Med. 2017 Jul;12(5):493-501. doi: 10.2217/rme-2017-0032. Epub 2017 Jun 21.
The main aim of this trial is to test the safety and efficacy of autologous stromal/stem cells, chondrocytes or the two combined in the treatment of knee cartilage defects.
PATIENTS & METHODS: Patients with symptomatic chondral/osteochondral defects will be randomized to cell therapy treatment with one of three cell populations (1:1:1). The primary efficacy outcome is a functional knee score (Lysholm) at 15 months post-treatment and the primary safety outcome is the incidence of adverse events. Secondary objectives are to analyze repair tissues, quality of life and cost-utility assessments. Exploratory objectives are to identify predictors for success/potency and dose-response relationships.
RESULTS & CONCLUSION: This trial has been carefully designed so that valuable scientific and clinical information can be gathered throughout and in the final analysis.
本试验的主要目的是测试自体基质/干细胞、软骨细胞或两者联合用于治疗膝关节软骨缺损的安全性和有效性。
有症状的软骨/骨软骨缺损患者将被随机分配接受三种细胞群体之一的细胞治疗（1:1:1）。主要疗效指标是治疗后15个月的膝关节功能评分（Lysholm评分），主要安全性指标是不良事件的发生率。次要目标是分析修复组织、生活质量和成本效益评估。探索性目标是确定成功/效力的预测因素和剂量反应关系。
本试验经过精心设计，以便在整个过程中以及最终分析中收集有价值的科学和临床信息。
