Randomized Trial of Regenexx Stem Cell Support Formula
Randomized Trial of Regenexx Stem Cell Support Formula
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.
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