Randomized Trial of Regenexx Stem Cell Support Formula

Not Applicable

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT04661267
• Lead Sponsor: Regenexx, LLC

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.

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-10
• Study Start: 2021-02-03
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-27
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Minimal Clinically Important Difference (MCID) for LEFS	2 months	Percentage of patients meeting the MCID for LEFS at 2 months
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.

Secondary Outcome Measures

Name	Time	Method
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline	Change from baseline to 1 months	The difference between groups of the within patient mean change from baseline to 1 months
Additional medications or treatments	Thru 2 months	Any additional treatments or medications
Numeric Pain Score (NPS) change from baseline	Change from baseline to 2 months	The difference between groups of the within patient mean change from baseline to 2 months.
Single Assessment Numeric Evaluation (SANE)-modified	2 months	The difference between groups for mean improvement scores at 2 months
Adverse events	Thru 2 months	Any complication or adverse event reported
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.
Minimal Clinically Important Difference (MCID) for IKDC	2 months	Percentage of patients meeting the MCID for IKDC at 2 months
Minimal Clinically Important Difference (MCID) for NPS	2 months	Percentage of patients meeting the MCID for NPS at 2 months

Trial Locations

Locations (1)

Centeno-Schultz Clinic; 🇺🇸 Lone Tree, Colorado, United States