EUCTR2011-005321-51-ES进行中（未招募）不适用
Treatment of osteoarthritis with allogeneic mesenchymal cells (MSV *). - Treatment of osteoarthritis with allogeneic mesenchymal cells (MSV *).
Parque Científico de la Universidad de Valladolid0 个研究点目标入组 30 人开始时间: 2011年11月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Gonarthrosis grade 2, 3 or 4 of Kellgren and Lawrence (Kellgren & Lawrence, 1957) assessed by two observers.
- •2. Chronic painful knee mechanical properties.
- •3. No local or systemic septic process.
- •4. Hematological and biochemical analysis without significant alterations that contraindicate treatment.
- •5. Written informed consent of the patient.
- •6. The patient is able to understand the nature of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient <18 years, or legally dependent
- •2. Patient> 65 years
- •3. Affected knee prior involvement in
- •4. Intraarticular treatment in the last 6 months.
- •5. Ligament disruption MRI image displayed on
- •6. Infection present (for inclusion in the study should not evidenced any sign infectious).
- •7. Congenital malformations or evolutionary translate and / or significant deformation of the knee and condition difficulties of implementation and evaluation of results.
- •8. Excess weight expressed as body mass index (BMI) 30.5 (obesity class II). As BMI = weight (kg): (height (m)) 2
- •9. Women who are pregnant or intend to become pregnant, or breastfeeding
- •10. neoplastic disease
- •11. immunosuppressive states
- •12. Simultaneous participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- •13. Other conditions or circumstances that compromise study participation medically
研究者
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