Mesenchymal Stem Cells Transplantation for Articular Cartilage Resurfacing in Patient With Osteoarthritis of Knee Joint
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Pain relief
研究概览
简要总结
Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in terms of social and economic, are palliative and do not contemplate healing by regenerative therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded in vitro and may regenerate several damaged or injured tissues. In addition its has demonstrated that MSC are able to modulate immune responses and to control inflammation through its action on T lymphocytes. Preliminary studies in animal models, including one carried out in an equine by the investigators research group, confirms feasibility, safety and efficacy evidence proposed treatment protocol.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.
详细描述
Mesenchymal stem cells are pluripotent cells that can be obtained from various tissues .They have shown capabilities to differentiate into bone,cartilage,muscle,and adipose tissue, representing a new clinical strategy in regenerative medicine.An increasing number of reports have demonstrated effectiveness of percutaneous intra-articular infusion of MSCs in arthritic disease. In this study we perform a single intra articular injection of cultured mesenchymal stem cells in patients suffering from osteoarthritis, with the aim to assess its clinical safety and efficacy.Patients are assessed for response with MRI, X-Ray examination, WOMAC osteoarthritis index,VAS, and SF36 2,4,8 weeks and 6, and 12 months post infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female patients not pregnant or lactating.
- •Patients with a history of corticosteroids or on active therapy, will only be eligible for enrollment if corticosteroid use is suspended for 1 month prior cell therapy
- •Marcaine 0.75% و Lidocaine 4% test performed to be assure the exact location of the pain is related to the knee.
- •Diagnosis must be based on magnetic resonance imaging.
- •Both genders
- •Age:18-65 years
排除标准
- •Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease.
- •Known allergic reaction to components of study treatment and/or study injection procedure
- •Patients infected with hepatitis B,C or HIV.
研究组 & 干预措施
Mesenchymal Injection
Intra Articular injection in Patients with osteoarthritis of knee joint
干预措施: Mesenchymal Injection (Biological)
结局指标
主要结局
Pain relief
时间窗: 6 months
evaluation the effect of Mesenchymal stem cell transplantation to decrease the patients pain
次要结局
- Pain relief(6 months)