Safety and Efficacy of a Novel Synovium Brushing Method for Endogenous Mesenchymal Stem Cells Mobilisation During Knee Joint Microfracture for Cartilage Repair.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- The mean change in the number of MSCs present in the knee pre- and post- microfracture/microfracture plus arthroscopic synovial brushing.
研究概览
简要总结
This is a proof-of-concept study to determine the safety and efficacy of a novel device to increase the reparative capacity of the knee. The discovery of a resident population of mesenchymal stem cells (MSCs) within synovial fluid (SF) was the first description of this reparative cell population having direct access to superficial cartilage and joint structures. The ready access of SF MSC to cartilage and other joint tissues offers a novel strategy for joint repair. Current arthroscopic procedures result in the removal of all SF MSCs due to continuous irrigation throughout the procedure. The current study would benefit the patient by greatly increasing the reparative capacity of the joint by bolstering MSC numbers and retaining those MSCs within the joint after surgery. By accessing MSCs from the synovium it is anticipated that these cells would be entrapped/migrate into the marrow clot formed by microfracture of the sub-chondral bone. These MSCs would supplement those from the marrow and may result in faster, better quality repair.
详细描述
The synovium is a rich source of potent chondrogenic mesenchymal stromal cells (MSCs). Gaining access to this valuable source of regenerative cells could improve the outcome of joint restorative procedures. To avoid costly two-stage procedures and ex vivo manipulation, exploiting these autologous cells in a minimally invasive way with minimal manipulation could provide a novel cost-effective approach.
This study will evaluate the safety, feasibility and efficacy of a novel medical device (a synovial brush) and procedure (synovial brushing) to increase the number of autologous minimally manipulated MSCs in the knee. Twenty patients undergoing microfracture for isolated chondral defects will be randomly assigned to either a control group (microfracture only, 10 patients) or the intervention group (microfracture plus synovial brushing, 10 patients). The device is intended to increase the number of MSCs within the joint as a final stage during surgery, aiding repair by bolstering those MSCs recruited from the bone marrow.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated cartilage defects (<2cm2)
- •Patients undergoing microfracture for repair of cartilage defects
排除标准
- •Septic arthritis
- •Infectious disease
- •Revision joint surgery
- •Meniscal damage requiring repair
- •Ligament damage requiring repair
- •Cartilage defect greater than 2cm2
- •Contra-indications for MRI:
- •Pacemakers, Implantable Cardioverter defibrillators, implantable cardiac loop recorders
- •Surgical clips within the head
- •Certain inner ear implants
- •Neuro-electrical stimulators
- •Metal fragments within the eye or head
结局指标
主要结局
The mean change in the number of MSCs present in the knee pre- and post- microfracture/microfracture plus arthroscopic synovial brushing.
时间窗: 2 weeds
次要结局
- Number of patients whose clinical effusion scores improve at 3, 6 and 12 months(3, 6 and 12 months)
- Number of patients whose semi-quantitative MRI cartilage scores improve at 6 and 12 months(up to 12 months)
- Median KOOS scores at 3, 6 and 12 months (pain; other symptoms; function in daily living; function in sport; knee-related QoL; average score)(3, 6 and 12 months)
- Visual Analogue Scale (VAS)(3, 6 and 12 months)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(3, 6 and 12 months)
研究者
Dennis McGonagle
Profession of Regenerative Medicine
University of Leeds