EUCTR2011-006270-13-ES进行中（未招募）不适用
A phase I-IIa safety and efficacy pilot clinical trial of intraarticular administration of autologous mesenchymal stem cells in meniscus injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Patient between 40 and 60 years of age
- •2. Degenerative meniscus infjury grade 3 (Crues et al.)
- •3. Indication of conservative treatment
- •4. Normal alignment of the knee (between 3º varus and 10 º valgus)
- •5.Patient is able to follow a rehabilitation program
- •6. Informed consent given by the patient in writing
- •7. Patient is able to understant the trial.
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Traumatic meniscus injury
- •2. Surgical intervention to the affected knee
- •3. Local or systemic infection
- •4. Intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months
- •5. Significant abnormal laboratory tests that contraindicates participation in the trial.
- •6. Pregnant women or intend to become pregnant or breast-feeding
- •7. The patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast.
- •8. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
- •9. The patient does not accept to be followed-up for a period that could exceed the clinical trial length
研究者
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