Mechanisms of Treatment Effects Using Cultured, Allogeneic Mesenchymal Stromal Stem Cells (MSCs) in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Biomarkers analysis with Enzyme-linked immunosorbent assay (ELISA) in synovial fluid
研究概览
简要总结
The goal of this clinical trial is to pharmacologically evaluate the effects of culturued allogeneic umbilical cord blood-derived mesenchymal stromal stem cell (UCB-MSCs) in the treatment of end-stage knee osteoarthritis (Kellgren-Lawrence grade 4) with the analysis of soluble biomarkers and expression of key genes, as well as the evaluation of clinical outcomes with patient-reported outcome measures (PROMs) and recording of potential complications.
Patients will be randomized in the intervention and control groups. In both groups, the knee aspiration will be performed 4-6 weeks prior to the knee arthroplasty to analyse baseline synovial fluid characteristics. The intervention group will receive the injection of UCB-MSCs. All patients will complete PROMs questionnaires and maintain a pain diary on visual analogue scale (VAS) at home until the surgery. On the day of admission to hospital for knee arthroplasty, the same questionnaires will be administered again. During the operative procedures, the samples of synovial fluid, synovial membrane and resected cartilage will be obtained and analysed afterwards.
It is anticipated that the study results will contribute to elucidate the mechanisms of action of MSCs in the treatment of knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with end-stage (Kellgren-Lawrence) knee osteoarthritis scheduled for knee arthroplasty
- •Osteoarthritis of primary or post-traumatic etiology
排除标准
- •Secondary arthritis of other etiology
- •Rheumatic diseases
- •Uncontrolled metabolic disorders
- •Crystalopathies
- •Coagulopathy
- •Anticoagulant therapy
- •Heart failure
- •Renal failure
- •Other conditions that may affect immune response or pose additional risk during cell application
研究组 & 干预措施
Intervention group
Knee aspiration and the application of UCB-MSCs
干预措施: Knee aspiration + UCB-MSCs (Biological)
Control group
Only knee aspiration, without the application of UCB-MSCs
干预措施: Knee aspiration (Other)
结局指标
主要结局
Biomarkers analysis with Enzyme-linked immunosorbent assay (ELISA) in synovial fluid
时间窗: After sampling
Enzyme-linked immunosorbent assay (ELISA) is the main approach for the sensitive quantification of protein biomarkers in body fluids and is currently employed in clinical laboratories for the measurement of clinical markers. It also constitutes the main methodological approach for biomarker validation and further qualification.
Quantitative real-time PCR (qRT-PCR) analysis of gene expression in chondrocytes and synoviocytes
时间窗: After sampling
Quantitative real-time PCR (qRT-PCR) is a major development of PCR technology that enables reliable detection and measurement of products generated during each cycle of PCR process. The detection of changes in fluorescence intensity during the reaction enables to follow the PCR reaction in real time. qRT-PCR is comprised of several steps: 1. RNA is isolated from target tissue/cells, 2. mRNA is reverse-transcribed to cDNA, 3. modified gene-specific PCR primers are used to amplify a segment of the cDNA of interest, following the reaction in real time, 4. the initial concentration of the selected transcript in a specific tissue or cell type is calculated from the exponential phase of the reaction.
Soluble biomarkers analysis with multiplex bead-based immunoassays Luminex in synovial fluid
时间窗: After sampling
Luminex assay is a type of immunoassay that precisely measures multiple analytes in one sample. It is a bead-based immunoassay that allows for multiplex detection of analytes simultaneously. Color-coded microspheres or beads are internally dyed with different proportions of red and infrared fluorophores that correspond to a distinct spectral signature or bead region. The quantification of multiple cytokines and other biomarkers in samples provides critical information about biological processes and diseases.
次要结局
- Serious Adverse Events (SAE)(Until 1 month after the application of UCB-MSCs)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(4-6 prior to surgery and at admission)
- EuroQol 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire(4-6 prior to surgery and at admission)
- EuroQol self-rated health on Visual Analogue Scale (EQ-VAS)(4-6 prior to surgery and at admission)
- Pain on Visual Analogue Scale (VAS)(4-6 prior to surgery and at admission)