ACTRN12611001046998已完成不适用
A Randomised Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of Autologous Non-Expanded Adipose Derived Stem Cells In The Treatment Of Knee Osteoarthritis
Regeneus Pty Ltd0 个研究点目标入组 40 人开始时间: 2011年10月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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
入排标准
- 年龄范围
- 40 Years 至 o limit（—）
- 性别
- All
入选标准
- •Aged over 40 years
- •Knee pain on most days of the last month
- •OARSI Grade 1 or 2 with joint space narrowing in either medial or lateral compartments
- •Osteophyte grade 2 or 3 in medial or lateral compartment without Joint Space Narrowing
- •Symptomatic Knee Osteoarthritis as measured by a pain score of at least 42 on the Numerical Rating Scale.
排除标准
- •Dementia or inability to give informed consent
- •Pregnancy or lactation
- •OARSI Grade 3 or above changes in either knee
- •Planned knee or hip joint replacement surgery
- •Positive blood test to HIV, HBV or HCV at Screening Visit
- •Positive nasal or groin swab for MRSA at Screening Visit
- •More than 2mm space in the knee joint on X-Ray at Screening Visit
- •Subjects with metal implants such as knee, hip or aortic valve prosthetics
- •Any clinically significant condition(s) that in the opinion of the investigator may compromise safety or compliance, interfere with evaluation or preclude completion of the study
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