NCT03074526已完成不适用
Prospective, Double Blinded Randomized Multi-Center Controlled Trial Evaluating the 2 Different Doses of Lyophilized Amniotic Fluid Compared to a Saline Placebo Injection in the Treatment of Subjects With Osteoarthritic (OA) Knee Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 8
- 主要终点
- Reduction in Pain
研究概览
简要总结
To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection, placebo control in the treatment of moderate osteoarthritis of the knee.
详细描述
Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x). The estimated enrollment period is 6 months. Each subject will receive 1 injection and be evaluated for efficacy and safety during a 6 month observation period. The study is expected to be completed within 12 months, inclusive of enrollment and follow-up for all subjects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 30 years or older.
- •Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
- •Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
- •Subject must have a VAS pain scale greater than 30.
排除标准
- •Subject has active infection at the injection site.
- •Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
- •BMI greater than 45 kg/m2
- •Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
- •Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
- •Subject has had major surgery or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
- •Subject is pregnant or plans to become pregnant within 180 days of treatment.
- •Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
- •Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
- •Subject has a history of immunosuppressive or chemotherapy in the last 5 years
- •Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
- •Subject has had prior radiation at the site
- •Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
- •New diagnosis of gout in the past 6 month
- •Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale.
- •Subject has a diagnosis of Osteonecrosis of the knee.
- •Subject has had a total knee replacement.
结局指标
主要结局
Reduction in Pain
时间窗: 3 month
The proportion of subjects who experience at least 20% improvement over baseline in Visual Analog Scale for Pain at 3 months in the Lyophilized amniotic fluid Injectable versus placebo-treated group.
次要结局
- Range of Motion(3 months)
- Knee Injury and Osteoarthritis Outcome Score(4weeks, 6weeks, 3 months, 16 weeks, 6 months)
- SF-12 Health Health Survey(4weeks, 6weeks, 3 months, 16 weeks, 6 months)
- Activity of Daily Living Questionnaire(4weeks, 6weeks, 3 months, 16 weeks, 6 months)
研究者
研究点 (8)
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