randomized trial of regenexx stem cell support formula

Conditions: Knee Osteoarthritis

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.

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.

Eligibility criteria:
inclusion criteria: 1. voluntary signature of the irb approved informed consent 2. unilateral or bilateral osteoarthritic male or female ages 18-80 3. pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint 4. physical examination consistent with osteoarthritis in knee joint 5. 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.) 6. minimum of 3/10 on nps approximately 3 days per week 7. is independent, ambulatory, and can comply with all post-operative evaluations and visits exclusion criteria: 8. previously taken the regenexx stem cell support formula 9. receiving active knee treatment or any knee injections of any type within 3 months prior to the study (steroids, biologics, etc) 10. knee surgery within 6 months prior to the study 11. currently taking or history of taking products that contain curcuminoid extract within the last 2 weeks 12. dependent on nsaids or acetaminophen for exercise or daily activities 13. currently taking or previously taken fish oil in the last 2 weeks 14. currently taking or previously taking msm or glucosamine in the last 2 weeks 15. diabetic 16. 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) 17. quinolone or statin-induced myopathy/tendinopathy 18. severe neurogenic inflammation of the cutaneous nerves about the knee or thigh 19. contraindications for mri 20. condition represents a worker's compensation case 21. currently involved in a health-related litigation procedure 22. is pregnant or breastfeeding 23. currently taking immunosuppressive medication 24. allergy or intolerance to study medication 25. use of chronic opioid 26. documented history of drug abuse within six months of treatment 27. blood clotting disorder, taking an anticoagulant or history of cardiovascular disease 28. has asthma 29. history of prostate cancer 29) any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment including current supplement use