Knee Osteoarthritis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTStem Cell Support Formula
This liquid supplement contains the following ingredients: chondroitin sulfate, glucosamine sulfate, vitamin C (ascorbic acid), curcumin and Bioperine®, resveratrol, L-carnosine, bitter melon, and vitamin D.
DIETARY_SUPPLEMENTPlacebo
The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula.
Sponsors
Regenexx, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower Extremity Function Scale (LEFS) change from baseline | Change from baseline to 2 months | The difference between groups of the within patient mean change from baseline to 2 months. |
| Minimal Clinically Important Difference (MCID) for LEFS | 2 months | Percentage of patients meeting the MCID for LEFS at 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal Clinically Important Difference (MCID) for IKDC | 2 months | Percentage of patients meeting the MCID for IKDC at 2 months |
| Numeric Pain Score (NPS) change from baseline | Change from baseline to 1 months | The difference between groups of the within patient mean change from baseline to 1 month. |
| Minimal Clinically Important Difference (MCID) for NPS | 2 months | Percentage of patients meeting the MCID for NPS at 2 months |
| Lower Extremity Function Scale (LEFS) change from baseline | Change from baseline to 1 month | The difference between groups of the within patient mean change from baseline to 1 month. |
| Adverse events | Thru 2 months | Any complication or adverse event reported |
| Additional medications or treatments | Thru 2 months | Any additional treatments or medications |
| Single Assessment Numeric Evaluation (SANE)-modified | 1 month | The difference between groups for mean improvement scores at 1 month |
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline | Change from baseline to 2 months | The difference between groups of the within patient mean change from baseline to 2 months |
Countries
United States
Outcome results
None listed