ACTRN12616001259437尚未招募2 期
A proof-of-concept study on the safety and efficacy of autologous stromal vascular fraction and platelet rich plasma for the treatment of symptomatic focal chondral lesions of the knee in comparison to accepted conservative management.
Cell-Innovations Pty Ltd0 个研究点目标入组 32 人开始时间: 2016年9月8日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
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 60 Years（—）
- 性别
- All
入选标准
- •1. Focal chondral lesions of the knee (as evidenced by MRI scan) with symptomatic pain and less than or equal to 6 cm2 in size.
- •2. Greater than 6 months knee pain with the index side (left or right) predominately on one side
- •3. A KOOS pain score greater than or equal to 65
- •4. Adequate blood chemistry and hematopoietic, renal, cardiovascular, respiratory, immunological function
排除标准
- •1. Subjects who have received investigational agents within 4 weeks (or 5 half-lives) of SVF/placebo infusion.
- •2. Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological (viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders.
- •3. Subjects who have had active neoplastic disease in the previous 3 years.
研究者
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