NCT02963727Unknown1 期
Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Wharton Jelly Derived Mesenchymal Stem Cells (WJMSC) for Advanced Stage III and IV KOA
Hanan Jafar2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年1月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evaluation of the safety and tolerability of the intra articular injection
研究概览
简要总结
Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) will be injected in patients diagnosed with Knee osteoarthrosis
详细描述
Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to strict inclusion and exclusion criteria. These patients will be injected with Wharton Jelly derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.
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
- 42 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe KOA stage III or IV by Laurance & Kellgren staging as judged by Posterioranterior (PA) Xray of the knee joint.
- •Willing to participate by signing the informed consent
排除标准
- •Sublaxation beyond 20 degrees of the bones of the knee joint
- •Oral anticoagulants or heparin therapy
- •Heart failure or arrhythmia
- •Body Mass Index > 35
- •Uncontrolled Diabetes Mellitus.
- •Evidence of Infectious Diseases.
- •Active infection
- •Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than
- •Unreliable patients
- •Non-resident in Jordan
结局指标
主要结局
Evaluation of the safety and tolerability of the intra articular injection
时间窗: 6 months
patients will be monitored for any adverse events resulting from the intraarticular injection of WJMSC
次要结局
- Assessment of the efficacy of intra-articular injection of WJMSC(12 months)
研究者
Hanan Jafar
Researcher
University of Jordan
研究点 (2)
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