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Completed

NCT Number: NCT04661267

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centeno-Schultz Clinic, Broomfield, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment including current supplement use

Treatment and study plan

Stem Cell Support Formula

Dietary Supplement

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.

Placebo

Dietary Supplement

The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula.

Primary outcomes

  1. Lower Extremity Function Scale (LEFS) change from baseline

    Time frame: Change from baseline to 2 months

    The difference between groups of the within patient mean change from baseline to 2 months.

  2. Minimal Clinically Important Difference (MCID) for LEFS

    Time frame: 2 months

    Percentage of patients meeting the MCID for LEFS at 2 months

Secondary outcomes

  1. Lower Extremity Function Scale (LEFS) change from baseline

    Time frame: Change from baseline to 1 month

    The difference between groups of the within patient mean change from baseline to 1 month.

  2. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline

    Time frame: Change from baseline to 2 months

    The difference between groups of the within patient mean change from baseline to 2 months

  3. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline

    Time frame: Change from baseline to 1 months

    The difference between groups of the within patient mean change from baseline to 1 months

  4. Minimal Clinically Important Difference (MCID) for IKDC

    Time frame: 2 months

    Percentage of patients meeting the MCID for IKDC at 2 months

  5. Numeric Pain Score (NPS) change from baseline

    Time frame: Change from baseline to 1 months

    The difference between groups of the within patient mean change from baseline to 1 month.

  6. Numeric Pain Score (NPS) change from baseline

    Time frame: Change from baseline to 2 months

    The difference between groups of the within patient mean change from baseline to 2 months.

  7. Minimal Clinically Important Difference (MCID) for NPS

    Time frame: 2 months

    Percentage of patients meeting the MCID for NPS at 2 months

  8. Single Assessment Numeric Evaluation (SANE)-modified

    Time frame: 1 month

    The difference between groups for mean improvement scores at 1 month

  9. Single Assessment Numeric Evaluation (SANE)-modified

    Time frame: 2 months

    The difference between groups for mean improvement scores at 2 months

  10. Adverse events

    Time frame: Thru 2 months

    Any complication or adverse event reported

  11. Additional medications or treatments

    Time frame: Thru 2 months

    Any additional treatments or medications

Sponsors and collaborators

Lead sponsor

Regenexx, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2020
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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