The Efficacy of Allogenic Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster University Osteoarthritis index (WOMAC)
研究概览
简要总结
Present research focuses on the potential of exosomes, which are small vesicles secreted by mesenchymal stem cells (MSCs), as a therapeutic approach for osteoarthritis (OA).
OA is a degenerative joint disorder characterized by the destruction of cartilage and loss of extracellular matrix. It's associated with pro-inflammatory cytokines and increased expression of matrix metalloproteinase (MMP) and "a disintegrin and metalloproteinase with thrombospondin motifs" (ADAMTS).
MSCs have been explored as a new treatment for OA over the last decade1. It's suggested that the paracrine secretion of trophic factors, in which exosomes play a crucial role, contributes to the mechanism of MSC-based treatment of OA.
Exosomes derived from MSCs may suppress OA development. They carry bioactive molecules of the parental cells, including non-coding RNAs (ncRNAs) and proteins and anti-inflammatory factors. These exosomes have shown a significant impact on the modulation of various physiological behaviors of cells in the joint cavity.
This research provides hope for developing more effective and predictable methods of using MSC-derived exosomes for OA treatment.
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 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic history (for at least 3 months) of knee joint pain
- •Body mass index (BMI) between 21.5 and 29.5
- •Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale)
排除标准
- •Rheumatoid arthritis and other rheumatic diseases
- •Varus or valgus more than 10 degrees; lateral subluxation of the patella
- •Deformity at the joint levels or adjacent to the knee due to fracture or any other injury
- •Complete rupture of the ligament and meniscus leading to laxity or locking
- •Serious systemic, oncohematological, autoimmune diseases; history of severe allergy; serious failure of vital organs, inability to walk
- •Hyaluronic acid infiltration within the previous six months
- •Hemoglobin levels <10 g/dL;
研究组 & 干预措施
Treatment
Patients with moderate to severe osteoarthritis, Kellgren-Lawrence grade 2,3 in both knees; accompanied by mild to moderate pain and swelling are included.
干预措施: Exosome (Biological)
结局指标
主要结局
Western Ontario and McMaster University Osteoarthritis index (WOMAC)
时间窗: 1, 3, and 6 months. The second injection is repeated in day 90 after first injection.
Filling out the WOMAC questionnaire, evaluating the measures related to knee function
次要结局
未报告次要终点
研究者
Leila Dehghani
Dr
Isfahan University of Medical Sciences