Effectivity of Allogenic Umbilical Cord Mesenchymal Stem Cells Conditioned Media for Osteoarthritis of the Knee Joint: A Clinical Study of Functional Score and Magnetic Resonance Imaging Evaluation Using CartiGram
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Functional Score 1. Knee Injury and Osteoarthritis Outcome Score (KOOS),
研究概览
简要总结
Osteoarthritis (OA) is a joint disorder that often occurs and causes disability. This disorder is characterized by an inflammatory reaction in the synovial joints accompanied by a gradual degeneration process in the articular cartilage and sub-chondral bone. Current research has discovered that stem cells produce conditioned media (secretome, extra vesicles, and exosomes) that have tissue regeneration, immunomodulation, anti-inflammatory, and anti-apoptotic capabilities. Research on conditioned media for umbilical cord mesenchymal stem cells is still at the in vivo stage in experimental animals. For this reason, this study aims to conduct clinical experimental research (translational study) in patients with knee joint OA who were given umbilical cord mesenchymal stem cell conditioned media via intra-articular injection.
详细描述
The research was conducted as a clinical trial and translational study, involving a single group treated with intra-articular secretome injection therapy derived from hypoxic umbilical cord mesenchymal stem cell conditioned media.
This study explores the clinical application of conditioned media from umbilical cord mesenchymal stem cells for treating knee OA. Our preliminary clinical trial involves administering this conditioned media via intra-articular injections to patients, followed by assessments using functional scores and MRI with T2 mapping sequence. This approach aims to harness the therapeutic potential of MSC derivatives in a clinical setting, offering a novel and potentially less invasive alternative to conventional OA treatments. The aim of this study is to evaluate the effectiveness of intra-articular injections of conditioned media from umbilical cord mesenchymal stem cells in improving knee joint function and structural integrity in patients with osteoarthritis, as assessed by MRI and functional scoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 45 years
- •primary knee joint OA Kellgrance-Lawrence grade 2 or 3,
- •never had surgery or intra-articular injection before,
排除标准
- •currently experiencing local infections and/or systemic infections,
- •have a history of autoimmune disorders or immunodeficiency,
- •have had surgery or injections on the knee joint,
研究组 & 干预措施
OA Knee
Knee Intraarticular Conditioned Media Injection
干预措施: Intra-articular secretome injection therapy (Biological)
结局指标
主要结局
Functional Score 1. Knee Injury and Osteoarthritis Outcome Score (KOOS),
时间窗: 2,4,6 Months
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Functional Score 2. Knee Society Score (KSS)
时间窗: 2,4,6 Months
The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Functional Score 3. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score
时间窗: 2,4,6 Months
Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
次要结局
- Radiographic Evaluation(2,4,6 Months)
研究者
Bintang Soetjahjo, SpOT (K), MD. PhD
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia