A Randomized, Double-Blind, Placebo-Controlled Trial of Regenexx Stem Cell Support Formula
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Regenexx, LLC
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Minimal Clinically Important Difference (MCID) for LEFS
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Minimal Clinically Important Difference (MCID) for LEFS
Time Frame: 2 months
Percentage of patients meeting the MCID for LEFS at 2 months
Lower Extremity Function Scale (LEFS) change from baseline
Time Frame: Change from baseline to 2 months
The difference between groups of the within patient mean change from baseline to 2 months.
Secondary Outcomes
- 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)