Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip in Patients With Osteonecrosis of the Femoral Head
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The quantity of mesenchymal stem cells present in the synovial fluid of patients with precollapse ON of the femoral head and postcollapse ON of the femoral head compared to patients without intraarticular hip pathology.
研究概览
简要总结
Previous studies have shown an increase in the concentration of mesenchymal stem cells (MSC's) in the setting of osteoarthritis of the knee and its correlation to severity. Researchers have shown that as there is an increase in the severity of the disease, the concentration of stem cells also increases. The purpose of this study is to determine if there is the same increase in stem cell concentration in patients with osteonecrosis (ON) of the femoral head.
详细描述
Since the treatment of osteonecrosis is related to the severity of disease, namely articular cartilage collapse, the purpose of this study is to determine if the MSC concentration in synovial fluid can be correlated to disease stage. In order to do this the investigators will:
Milestone #1:
Determine the concentration of MSC's in the synovial fluid in patients with osteonecrosis. This work will be carried out utilizing FACS-based technique to synovial fluid stem cell sub-population.
Milestone #2:
Compare concentrations of MSC's in patients with pre collapse, post collapse osteonecrosis and "normal" hips. Patient-derived MSC will be quantified at the different stages of disease and assays will be performed in order to assess their viability. A control group will be selected in patients undergoing hip arthroscopy for femoral/acetabular impingement (FAI). Since FAI does not affect the intraarticular environment of the hip, theoretically these patients would have a "normal" concentration of synovial stem cells.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients consented to undergo a THA (post-collapse osteonecrosis), hip arthroscopy or minimally invasive core decompression
- •Preoperative radiographic diagnosis of ON or FAI (femoral/acetabular impingement)
排除标准
- •Pregnant females
- •Active infection, HIV, Hepatitis C or B, syphilis Immunodeficiency
- •Patients receiving hematopoetic growth factors or anti-angiogenesis products
结局指标
主要结局
The quantity of mesenchymal stem cells present in the synovial fluid of patients with precollapse ON of the femoral head and postcollapse ON of the femoral head compared to patients without intraarticular hip pathology.
时间窗: 24 months
Previous studies have shown an increase in the concentration of MSCs in the setting of osteoarthritis of the knee and its correlation to severity. Researchers have shown that as there is an increase in the severity of the disease, the concentration of stem cells also increases. The purpose of this study is to determine if there is the same increase in stem cell concentration in patients with osteonecrosis (ON) of the femoral head. Since the treatment of osteonecrosis is related to the severity of disease, namely articular cartilage collapse, the purpose of this study is to determine if the MSC concentration in synovial fluid can be correlated to disease stage.
次要结局
未报告次要终点
研究者
Rafael J. Sierra, M.D.
Professor of Orthopedics
Mayo Clinic