Clinical trial NCT04661267: Randomized Trial of Regenexx Stem Cell Support Formula
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Regenexx Stem Cell Support Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Regenexx, LLC
Sponsor class: INDUSTRY
First posted: 2020-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Lower Extremity Function Scale (LEFS) change from baseline
timeFrame: Change from baseline to 2 months
measure: Minimal Clinically Important Difference (MCID) for LEFS
timeFrame: 2 months
Secondary outcomes:
measure: Lower Extremity Function Scale (LEFS) change from baseline
timeFrame: Change from baseline to 1 month
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline
timeFrame: Change from baseline to 2 months
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline
timeFrame: Change from baseline to 1 months
measure: Minimal Clinically Important Difference (MCID) for IKDC
timeFrame: 2 months
measure: Numeric Pain Score (NPS) change from baseline
timeFrame: Change from baseline to 1 months
measure: Numeric Pain Score (NPS) change from baseline
timeFrame: Change from baseline to 2 months
measure: Minimal Clinically Important Difference (MCID) for NPS
timeFrame: 2 months
measure: Single Assessment Numeric Evaluation (SANE)-modified
timeFrame: 1 month
measure: Single Assessment Numeric Evaluation (SANE)-modified
timeFrame: 2 months
measure: Adverse events
timeFrame: Thru 2 months
measure: Additional medications or treatments
timeFrame: Thru 2 months
Other outcomes:
Locations:
city: Broomfield
country: United States
facility: Centeno-Schultz Clinic
state: Colorado
city: Lone Tree
country: United States
facility: Centeno-Schultz Clinic
state: Colorado
Study officials:
affiliation: Regenexx, LLC and Centeno-Schultz Clinic
name: Christopher Centeno, MD
role: PRINCIPAL_INVESTIGATOR
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