Randomized Trial of Regenexx Stem Cell Support Formula

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Trial of Regenexx Stem Cell Support Formula

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: Stem Cell Support Formula
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary signature of the IRB approved Informed Consent Unilateral or bilateral osteoarthritic male or female ages 18-80 Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint Physical examination consistent with osteoarthritis in knee joint 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.) Minimum of 3/10 on NPS approximately 3 days per week Is independent, ambulatory, and can comply with all post-operative evaluations and visits Exclusion Criteria: Previously taken the Regenexx Stem Cell Support Formula Receiving active knee treatment or any knee injections of any type within 3 months prior to the study (steroids, biologics, etc) Knee surgery within 6 months prior to the study Currently taking or history of taking products that contain curcuminoid extract within the last 2 weeks Dependent on NSAIDs or acetaminophen for exercise or daily activities Currently taking or previously taken fish oil in the last 2 weeks Currently taking or previously taking MSM or glucosamine in the last 2 weeks Diabetic 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) Quinolone or statin-induced myopathy/tendinopathy Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh Contraindications for MRI Condition represents a worker's compensation case Currently involved in a health-related litigation procedure Is pregnant or breastfeeding Currently taking immunosuppressive medication Allergy or intolerance to study medication Use of chronic opioid Documented history of drug abuse within six months of treatment Blood clotting disorder, taking an anticoagulant or history of cardiovascular disease Has asthma 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement formula<br>Patients randomized to the experimental group will receive daily 1-ounce doses of stem cell support formula for 60 days. Patients will complete patient-reported outcome questionnaires at 1 month and 2 months. | Dietary Supplement: Stem Cell Support Formula<br>* 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.<br>|
| Placebo Comparator: Placebo formula<br>Patients randomized to the control group will receive a daily 1-ounce doses of placebo stem cell support formula for 60 days. Patients will complete patient-reported outcome questionnaires at 1 month and 2 months. | Dietary Supplement: Placebo<br>* The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Extremity Function Scale (LEFS) change from baseline | The difference between groups of the within patient mean change from baseline to 2 months. | Change from baseline to 2 months | 
| Minimal Clinically Important Difference (MCID) for LEFS | Percentage of patients meeting the MCID for LEFS at 2 months | 2 months | 

Secondary Outcome Measures

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