search
Back to results

Randomized Trial of Regenexx Stem Cell Support Formula

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stem Cell Support Formula
Placebo
Sponsored by
Regenexx, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centeno-Schultz Clinic
  • Centeno-Schultz Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Supplement formula

Placebo formula

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2020
Last Updated
December 27, 2022
Sponsor
Regenexx, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT04661267
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regenexx, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplement formula
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo formula
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Stem Cell Support Formula
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula.
Primary Outcome Measure Information:
Title
Lower Extremity Function Scale (LEFS) change from baseline
Description
The difference between groups of the within patient mean change from baseline to 2 months.
Time Frame
Change from baseline to 2 months
Title
Minimal Clinically Important Difference (MCID) for LEFS
Description
Percentage of patients meeting the MCID for LEFS at 2 months
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Lower Extremity Function Scale (LEFS) change from baseline
Description
The difference between groups of the within patient mean change from baseline to 1 month.
Time Frame
Change from baseline to 1 month
Title
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline
Description
The difference between groups of the within patient mean change from baseline to 2 months
Time Frame
Change from baseline to 2 months
Title
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline
Description
The difference between groups of the within patient mean change from baseline to 1 months
Time Frame
Change from baseline to 1 months
Title
Minimal Clinically Important Difference (MCID) for IKDC
Description
Percentage of patients meeting the MCID for IKDC at 2 months
Time Frame
2 months
Title
Numeric Pain Score (NPS) change from baseline
Description
The difference between groups of the within patient mean change from baseline to 1 month.
Time Frame
Change from baseline to 1 months
Title
Numeric Pain Score (NPS) change from baseline
Description
The difference between groups of the within patient mean change from baseline to 2 months.
Time Frame
Change from baseline to 2 months
Title
Minimal Clinically Important Difference (MCID) for NPS
Description
Percentage of patients meeting the MCID for NPS at 2 months
Time Frame
2 months
Title
Single Assessment Numeric Evaluation (SANE)-modified
Description
The difference between groups for mean improvement scores at 1 month
Time Frame
1 month
Title
Single Assessment Numeric Evaluation (SANE)-modified
Description
The difference between groups for mean improvement scores at 2 months
Time Frame
2 months
Title
Adverse events
Description
Any complication or adverse event reported
Time Frame
Thru 2 months
Title
Additional medications or treatments
Description
Any additional treatments or medications
Time Frame
Thru 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Centeno, MD
Organizational Affiliation
Regenexx, LLC and Centeno-Schultz Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centeno-Schultz Clinic
City
Broomfield
State/Province
Colorado
ZIP/Postal Code
80021
Country
United States
Facility Name
Centeno-Schultz Clinic
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27776166
Citation
Someya A, Ikegami T, Sakamoto K, Nagaoka I. Glucosamine Downregulates the IL-1beta-Induced Expression of Proinflammatory Cytokine Genes in Human Synovial MH7A Cells by O-GlcNAc Modification-Dependent and -Independent Mechanisms. PLoS One. 2016 Oct 24;11(10):e0165158. doi: 10.1371/journal.pone.0165158. eCollection 2016.
Results Reference
background
PubMed Identifier
21826146
Citation
Jerosch J. Effects of Glucosamine and Chondroitin Sulfate on Cartilage Metabolism in OA: Outlook on Other Nutrient Partners Especially Omega-3 Fatty Acids. Int J Rheumatol. 2011;2011:969012. doi: 10.1155/2011/969012. Epub 2011 Aug 2.
Results Reference
background
PubMed Identifier
14654169
Citation
Du CB, Liu JW, Su W, Ren YH, Wei DZ. The protective effect of ascorbic acid derivative on PC12 cells: involvement of its ROS scavenging ability. Life Sci. 2003 Dec 26;74(6):771-80. doi: 10.1016/j.lfs.2003.07.014.
Results Reference
background
PubMed Identifier
28512473
Citation
D'Aniello C, Cermola F, Patriarca EJ, Minchiotti G. Vitamin C in Stem Cell Biology: Impact on Extracellular Matrix Homeostasis and Epigenetics. Stem Cells Int. 2017;2017:8936156. doi: 10.1155/2017/8936156. Epub 2017 Apr 20.
Results Reference
background
PubMed Identifier
29391517
Citation
Larasati YA, Yoneda-Kato N, Nakamae I, Yokoyama T, Meiyanto E, Kato JY. Curcumin targets multiple enzymes involved in the ROS metabolic pathway to suppress tumor cell growth. Sci Rep. 2018 Feb 1;8(1):2039. doi: 10.1038/s41598-018-20179-6.
Results Reference
background
PubMed Identifier
13679076
Citation
Leonard SS, Xia C, Jiang BH, Stinefelt B, Klandorf H, Harris GK, Shi X. Resveratrol scavenges reactive oxygen species and effects radical-induced cellular responses. Biochem Biophys Res Commun. 2003 Oct 3;309(4):1017-26. doi: 10.1016/j.bbrc.2003.08.105.
Results Reference
background
PubMed Identifier
24520218
Citation
Prasad S, Tyagi AK, Aggarwal BB. Recent developments in delivery, bioavailability, absorption and metabolism of curcumin: the golden pigment from golden spice. Cancer Res Treat. 2014 Jan;46(1):2-18. doi: 10.4143/crt.2014.46.1.2. Epub 2014 Jan 15.
Results Reference
background
PubMed Identifier
26904160
Citation
Prokopieva VD, Yarygina EG, Bokhan NA, Ivanova SA. Use of Carnosine for Oxidative Stress Reduction in Different Pathologies. Oxid Med Cell Longev. 2016;2016:2939087. doi: 10.1155/2016/2939087. Epub 2016 Jan 24.
Results Reference
background
PubMed Identifier
26968675
Citation
Dandawate PR, Subramaniam D, Padhye SB, Anant S. Bitter melon: a panacea for inflammation and cancer. Chin J Nat Med. 2016 Feb;14(2):81-100. doi: 10.1016/S1875-5364(16)60002-X.
Results Reference
background

Learn more about this trial

Randomized Trial of Regenexx Stem Cell Support Formula

We'll reach out to this number within 24 hrs