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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.
Full 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.
Enrollment
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Inclusion and exclusion 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
Diabetic
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
Has asthma
History of prostate cancer
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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