A Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) Vs. Sterile Amniotic Fluid for Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Repeat allogeneic intra-articular injection within 6 months.
研究概览
简要总结
This is a Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) vs. Sterile Amniotic Fluid for Osteoarthritis
详细描述
This study will look at blinded standard of care (SOC) steroid injection vs. amniotic fluid injection (pAF) to treat and reduce osteoarthritis (OA) inflammation and pain. The main objectives of this study are to establish the safety and tolerability of allogeneic intra-articular pAF injections. Secondary objectives include pain levels and functional outcome scoring in patients over a 12 month time frame.
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)
盲法说明
Half of the patients will be in the SOC treatment arm and half of the patients will be in the AF arm. The PI and patients will be blinded as to the arm in which they will be participating. Once the randomization number is obtained, unblinded research staff will prepare the appropriate study drug. The injections will be blinded to the research coordinator in charge of data entry, the treating physician and the patient.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are between the ages of 18-70 years
- •A confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings consistent with Kellgren-Lawrence Stage 2-3 disease
- •Patients who have failed conservative treatment (e.g. steroid, activity modification, therapy, etc.) within 3 months
- •Unilateral or bilateral chronic knee joint pain >4 months
- •Patients who are able to ambulate (i.e. not wheelchair bound)
- •Patient reported a typical pain of at least 4 out of 10 during the past week using VAS numeric pain scale (0-10)
- •Patients who are of childbearing potential must agree to use adequate contraception for 90 days after study drug injection
排除标准
- •Subjects who have had a previous injection (i.e. steroid, platelet rich plasma, or other) within the last 3 months
- •A focal chondral defect, defined by x-ray evaluation
- •BMI >40 as defined by NIH Clinical Guidelines Body Mass Index
- •Concurrent participation in another investigational trial involving systemic administration of agents (within the previous 30 days) or plans to participate in any other allogeneic stem cell therapy trial during the 12 month follow-up period
- •Clinical suspicion of infection at injection site
- •Any surgeries within 4 weeks, other than diagnostic surgery
- •Insulin or self-reported non-insulin dependent diabetic evident of HgA1c ≥8% among known diabetics
- •Unable to consent to an English Language Consent Form
- •Frank mechanical issues (i.e. locking of the knee)
- •Workman's Compensation cases
- •Rheumatoid arthritis
- •Patients with a known allergy to local anesthetics or components of the study drug (pAF or steroid injection)
- •Patients with vascular claudication or neurologic disorders affecting the index lower limb
- •Patients with inflammatory arthropathies or connective tissue disorders; or
- •Patients with known alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have used medical marijuana within 7 days of study enrollment
- •Patients with history of active cancer/malignancy within 2 years of screening, apart from adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target knee
- •Women who are nursing or pregnant
- •Patients of childbearing potential who are unwilling to use adequate contraception for 90 days after study drug injection
研究组 & 干预措施
Amniotic Fluid Injection
Amniotic Fluid Injection, 3ml, one time dose.
干预措施: Amniotic Fluid Injection (Biological)
Standard of Care Steroid Injection
Corticosteroids, 3ml, one time dose.
干预措施: Standard of Care (Other)
结局指标
主要结局
Repeat allogeneic intra-articular injection within 6 months.
时间窗: 6 months
Participants in both the SOC and pAF treatment arms may require and/or request rescue medication (i.e. SOC injection) at any time and will be given per PI discretion as part of standard of care. The clinicians will not know which study arm the study participant is in but will treat the participant with the SOC injection. This information will be documented and collected in the Electronic Medical Record (EMR), as well as the study's electronic data capture system. Participants will not be given any additional pAF injections throughout the study period. The participant will continue to be treated with SOC injections as needed. The outcome will be an indicator of whether or not a subject received a rescue medication within 6 months.
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(6 months)
- Visual Analog Scale for pain (VAS Pain)(6 months)
- Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT)(6 months)
- Single Assessment Numerical Evaluation (SANE)(6 months)
研究者
David Petron
Principal Investigator
University of Utah