NCT03543800Unknown不适用
Comparison of Conventional Platelet-Rich Plasma Treatment of Osteoarthritic Knee With a New Autologous Blood Product (CytoRich)
Antnor2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年2月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- VAS pain score
研究概览
简要总结
This study is aimed at evaluating the efficacy and safety of Cytorich compared to platelet-rich plasma (PRP) in alleviating pain and improving function in subjects with knee OA.
详细描述
This active-controlled, randomized, double-blind, prospective study will enroll subjects with knee OA. Subjects will be randomized equally to treatment with 4 injections of ABP (test treatment) or 4 injections of PRP (active control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Radiographic confirmation of OA in the knee and screening knee pain score of >50 mm on a 100 mm visual analog scale (VAS) for at least one knee.
排除标准
- •Female who is pregnant, lactating, or unwilling to use adequate contraception during the clinical study.
- •Subject who had viscosupplementation within 3 months of screening.
- •Subject treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 72 hours of screening.
- •Subject who received steroid treatment within 8 weeks of screening.
- •Subject who had an acute disease or trauma within 6 weeks of screening.
- •Subject with any major surgery, arthoplasty or arthroscopy in the target knee or lower extremities within 6 weeks of screening (or any planned surgeries throughout the duration of the study).
- •Subject with a major dysplasia or congenital abnormality of the knee or a condition which may affect the knee (i.e., osteonecrosis, chondrocalcinosis).
- •Subject with a primary inflammatory arthropathy (i.e., rheumatoid arthritis, psoriatic arthritis, gouty arthritis).
- •Subject with knee joint infection, skin diseases, or infections in or near the area of injection.
- •Subject with any musculoskeletal condition that would impede measurement of the effectiveness at the knee (in particular symptomatic hip OA).
- •Subject with any claudication or peripheral vascular disease.
- •Subject with active malignancy or that has been in treatment for a malignancy within the past 3 years.
- •Subject with uncontrolled diabetes mellitus, diabetic neuropathy, or complications from infection.
- •Subject with known sensitivity to citric acid.
- •Subject taking oral or parental anticoagulant therapy other than acetylsalicylic acid 325 mg per day or less.
- •Subject with active disease that may require periodic treatment with systemic steroids during the study period.
- •Subject with other diseases or conditions as assessed by the Investigator that may limit the ability to perform necessary study evaluations (e.g., active alcohol abuse, active drug abuse, significant psychiatric or neurological disorders, planned relocation, etc.) or any other factors (e.g., ongoing litigation for workers compensation for musculoskeletal injuries or disorders) that may compromise the subject's ability to participate in this study
结局指标
主要结局
VAS pain score
时间窗: Week 12 (Day 85) compared to baseline for ABP and PRP
Change in VAS pain score
次要结局
- WOMAC pain and function score(Week 12 (Day 85) compared to baseline for ABP and PRP)
研究者
研究点 (2)
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