Randomized Trial of Regenexx Stem Cell Support Formula
Completed · Not applicable · Has a placebo group
Conditions studied: Knee Osteoarthritis
In brief
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.
Key facts
- Study ID
- NCT04661267
- Run by
- Regenexx, LLC
- People needed
- 80
- Starts
- 2021-02-03
- Expected to finish
- 2022-10-31
- Last updated by the study team
- 2022-12-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment including current supplement use
Where it is running
- Centeno-Schultz Clinic — Broomfield, Colorado, United States
- Centeno-Schultz Clinic — Lone Tree, Colorado, United States
Full record on ClinicalTrials.gov
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