A Phase 2B, Prospective, Double-blinded, Randomized Controlled Trial of the Micronized Dehydrated Human Amnion Chorion Membrane Injection as Compared to Saline Placebo Injection in the Treatment of Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 447
- 试验地点
- 16
- 主要终点
- Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis
详细描述
Each subject will receive 1 injection (micronized dHACM or placebo) and be evaluated for efficacy and safety during a 12-month observation period. A second injection (open-label access to micronized dHACM) will be offered to all subjects at the 180-day, 270-day, and 365-day time points, it may only be used once. Blinding for the first injection treatment allocation will be maintained until the end of the study.
Subjects who receive the open-label access treatment will continue to be followed for 180 days after this second injection, regardless of the time at which treatment was received.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 and ≤ 80 years
- •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 45
排除标准
- •Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
- •BMI greater than 40 kg/m^2
- •Subject has active infection at the injection site
- •Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy.
- •Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer
- •Subject has documented history of gout or pseudo-gout
- •Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
- •Subject has received any of the following to the target knee:
- •Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
- •Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
- •Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
- •History of a total knee arthroplasty
- •Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
- •Subject has a history of immunosuppressive or chemotherapy in the last 5 years
- •Subject has had prior radiation at the site
- •Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
- •Subject is pregnant or plans to become pregnant within 365 days of treatment
- •Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- •Subject is a worker's compensation patient
- •Subject is a prisoner
研究组 & 干预措施
Micronized dHACM
Injection of micronized dHACM
干预措施: Micronized dHACM (Biological)
Saline
Injection of 0.9% Sodium Chloride Injection, USP
干预措施: Saline (Drug)
结局指标
主要结局
Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs)
时间窗: 365 days
Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported
Primary Efficacy Endpoint: Change From Baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 Days
时间窗: 90 days
Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales: * Pain (5 questions) * Stiffness (2 questions) * Physical Function (17 questions) The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Primary Safety Endpoint: Number of Participants With Adverse Events (AEs)
时间窗: 365 days
Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported
Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days
时间窗: 90 days
Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events
时间窗: 365 days
Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported
次要结局
- Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days(180 days)
- Secondary Endpoint:Change From Baseline in WOMAC at 180 Days(180 days)