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Randomized Trial of Regenexx Stem Cell Support Formula

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ClinicalTrials.gov Identifier: NCT04661267
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
Regenexx, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Dietary Supplement: Stem Cell Support Formula Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Regenexx Stem Cell Support Formula
Actual Study Start Date : February 3, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Supplement formula
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
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 Comparator: Placebo formula
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
The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661267


Contacts
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Contact: Ehren Dodson, PhD 7202877199 edodson@regenexx.com
Contact: Neven Steinmetz, PhD 303-429-6448 ext 141 nsteinmetz@regenexx.com

Locations
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United States, Colorado
Centeno-Schultz Clinic Recruiting
Broomfield, Colorado, United States, 80021
Contact: Eric Speer, MBA       espeer@centenoschultz.com   
Principal Investigator: Christopher Centeno, MD         
Sub-Investigator: John Schultz, MD         
Sub-Investigator: John Pitts, MD         
Sub-Investigator: Jason Markle, DO         
Sub-Investigator: Matthew Hyzy, DO         
Centeno-Schultz Clinic Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Eric Speer    303-429-6448    espeer@centenoschultz.com   
Principal Investigator: Christopher Centeno, MD         
Sub-Investigator: Matthew Hyzy, DO         
Sponsors and Collaborators
Regenexx, LLC
Investigators
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Principal Investigator: Christopher Centeno, MD Regenexx, LLC and Centeno-Schultz Clinic
More Information
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Publications:

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Responsible Party: Regenexx, LLC
ClinicalTrials.gov Identifier: NCT04661267    
Other Study ID Numbers: RGX2020-RCT02
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases