Use of Mesenchymal Stem Cells for the Repair of Articular Cartilage Disorder of Knee Using Intra-articular Injection of Mesenchymal Cells Alone or Mesenchymal Cells With Platelet Lysate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.
研究概览
简要总结
Induction of autologous repair chondrogenesis to regenerate injured articular cartilage using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.
详细描述
Fourteen patients from both genders, age range 40-68, will be enrolled according to strict inclusion and exclusion criteria, divided into two equal groups based upon receiving autologous MSCs alone, or MSCs supported by platelet lysate through percutaneous injection.
The patients are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.
The investigators hypothesize that the two groups will give satisfactory clinical outcomes, but the investigators are looking forward to assessing the best product that will activate chondrogenesis and heal cartilaginous injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MRI must show moderate/severe articular injury
- •Serum collagen II must be above the normal value.
- •Lesion site: Femoral and Tibial condyles or patella
- •Admission of steroid , NSAID, pain killers must be stopped before 1 month
排除标准
- •Lesion size
- •PT and PTT not within normal value
- •Complete blood count ( Hb, PCV, and RBC) not within the normal value
- •HIV and Hepatitis Antigens (B and C) detection
研究组 & 干预措施
mesenchymal stem cells
Autologous Mesenchymal Stem Cells primed prior to intra articular injection into knees of patients with advanced articular cartilage injury
干预措施: Autologous Mesenchymal Stem Cells (Biological)
mesenchymal cells&platelet lysate
Autologous Mesenchymal Stem Cells primed prior to intra articular injection with platelet lysate into knees of patients with advanced articular cartilage injury
干预措施: Autologous Mesenchymal Stem Cells (Biological)
结局指标
主要结局
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells.
时间窗: 12 months
次要结局
- Assessment of the articular cartilage healing in osteoarthritic patients through intra articular injection of Autologus Mesenchymal stem cell with/or without supported product.(12 months)
研究者
Fatima Jamali
Researcher
University of Jordan