ACTRN12617001095358已完成1 期
A Phase I, single centre, randomised, double blind, placebo-controlled, single ascending dose (SAD) study to evaluate the safety and tolerability of allogeneic adipose-derived mesenchymal stem cells (MAG200) administered by intra-articular injection to patients with symptomatic osteoarthritis of the knee.
Magellan Biologicals Pty Ltd0 个研究点目标入组 40 人开始时间: 2017年7月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •i) Body mass index BMI must be 'greater than or equal' to 19.0 kg/m2 and 'less than or equal to' 35.0 kg/m2;
- •ii) A documented diagnosis of osteoarthritis (Grade 2 or Grade 3) of the study knee
排除标准
- •i) MRI-confirmed displaced meniscal tear, ligament deficiency or generalised Grade 4 chondral loss in the study knee.
- •ii) History of or suspected infective or inflammatory joint disorders.
- •iii) Joint surgery within 3 years prior to study start.
- •iv) Females who are pregnant or planning a pregnancy during the following 12 months.
- •v) Any contraindication to intra-articular injection.
- •vi) Any contraindication to an X-ray or MRI of the study knee.
研究者
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