A Randomized, Double-Blind, Placebo-Controlled Trial of Regenexx Stem Cell Support Formula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Minimal Clinically Important Difference (MCID) for LEFS
研究概览
简要总结
Regenexx, LLC developed a nutritional supplement formula containing many components related to supporting healthy joints This oral, liquid supplement is intended to help improve joint and cartilage health while also increasing their joint function. The goal of this study is to measure changes in joint health and function for patients with knee OA taking this supplement for 2 months.
详细描述
The study design is a double-blind, randomized, placebo-controlled multicenter study. Liquid Regenexx Stem Cell Support Formula compared to placebo control administered via oral application for 2 months to determine effect on knee function and pain in patients with knee OA.
Treatment group: Forty patients randomized to the treatment group will receive daily doses of stem cell support formula for 60 days. Patients will complete patient-reported outcome questionnaires at 1 month and 2 months.
Control group: Forty patients randomized to the control group will receive a daily doses of placebo stem cell support formula for 60 days. Patients will complete patient-reported outcome questionnaires at 1 month and 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
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
- 否
入选标准
- •Voluntary signature of the IRB approved Informed Consent
- •Unilateral or bilateral osteoarthritic male or female ages 18-80
- •Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint
- •Physical examination consistent with osteoarthritis in knee joint
- •Kellgren-Lawrence grade 2 or 3 knee osteoarthritis and/or diagnostic MRI imaging of the affected knee showing osteoarthritis (i.e. chondral loss, fissuring, defect, bone marrow lesion, meniscus tear, synovial thickening, etc.)
- •Minimum of 3/10 on NPS approximately 3 days per week
- •Is independent, ambulatory, and can comply with all post-operative evaluations and visits
排除标准
- •Previously taken the Regenexx Stem Cell Support Formula
- •Receiving active knee treatment or any knee injections of any type within 3 months prior to the study (steroids, biologics, etc)
- •Knee surgery within 6 months prior to the study
- •Currently taking or history of taking products that contain curcuminoid extract within the last 2 weeks
- •Dependent on NSAIDs or acetaminophen for exercise or daily activities
- •Currently taking or previously taken fish oil in the last 2 weeks
- •Currently taking or previously taking MSM or glucosamine in the last 2 weeks
- •Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
- •Quinolone or statin-induced myopathy/tendinopathy
- •Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
- •Contraindications for MRI
- •Condition represents a worker's compensation case
- •Currently involved in a health-related litigation procedure
- •Is pregnant or breastfeeding
- •Currently taking immunosuppressive medication
- •Allergy or intolerance to study medication
- •Use of chronic opioid
- •Documented history of drug abuse within six months of treatment
- •Blood clotting disorder, taking an anticoagulant or history of cardiovascular disease
- •History of prostate cancer
- •Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment including current supplement use
结局指标
主要结局
Minimal Clinically Important Difference (MCID) for LEFS
时间窗: 2 months
Percentage of patients meeting the MCID for LEFS at 2 months
Lower Extremity Function Scale (LEFS) change from baseline
时间窗: Change from baseline to 2 months
The difference between groups of the within patient mean change from baseline to 2 months.
次要结局
- International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline(Change from baseline to 1 months)
- Additional medications or treatments(Thru 2 months)
- Numeric Pain Score (NPS) change from baseline(Change from baseline to 2 months)
- Single Assessment Numeric Evaluation (SANE)-modified(2 months)
- Adverse events(Thru 2 months)
- Lower Extremity Function Scale (LEFS) change from baseline(Change from baseline to 1 month)
- Minimal Clinically Important Difference (MCID) for IKDC(2 months)
- Minimal Clinically Important Difference (MCID) for NPS(2 months)