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Knee OsteoarthritisNCT04661267

Randomized Trial of Regenexx Stem Cell Support Formula

A study testing Stem Cell Support Formula in people with Knee Osteoarthritis, run by Regenexx, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Stem Cell Support Formula
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesUnited States
Study dates
3 Feb 2021to 31 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Centeno-Schultz Clinic

    Broomfield, Colorado, 80021

  • Centeno-Schultz Clinic

    Lone Tree, Colorado, 80124

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled 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.

Read the 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.

Being tested
Stem Cell Support Formula, Placebo
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stem Cell Support FormulaDietary 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.

  • PlaceboDietary supplement

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

Study groups in NCT04661267
Study groupRoleWhat they receive
Supplement formulaExperimentalPatients 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.
Receives: Dietary Supplement: Stem Cell Support Formula
Placebo formulaPlacebo comparatorPatients 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.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Change from baseline to 2 months

  2. Minimal Clinically Important Difference (MCID) for LEFS

    Percentage of patients meeting the MCID for LEFS at 2 months

    Measured: 2 months

Secondary outcomes (11)

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

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

    Measured: Change from baseline to 1 month

  2. 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

    Measured: Change from baseline to 2 months

  3. 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

    Measured: Change from baseline to 1 months

  4. Minimal Clinically Important Difference (MCID) for IKDC

    Percentage of patients meeting the MCID for IKDC at 2 months

    Measured: 2 months

  5. Numeric Pain Score (NPS) change from baseline

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

    Measured: Change from baseline to 1 months

  6. Numeric Pain Score (NPS) change from baseline

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

    Measured: Change from baseline to 2 months

  7. Minimal Clinically Important Difference (MCID) for NPS

    Percentage of patients meeting the MCID for NPS at 2 months

    Measured: 2 months

  8. Single Assessment Numeric Evaluation (SANE)-modified

    The difference between groups for mean improvement scores at 1 month

    Measured: 1 month

  9. Single Assessment Numeric Evaluation (SANE)-modified

    The difference between groups for mean improvement scores at 2 months

    Measured: 2 months

  10. Adverse events

    Any complication or adverse event reported

    Measured: Thru 2 months

  11. Additional medications or treatments

    Any additional treatments or medications

    Measured: Thru 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2020
  2. Study start3 Feb 2021
  3. Primary completion31 Oct 2022
  4. Study completion31 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04661267
Sponsor's protocol ID
RGX2020-RCT02
Status last verified
Dec 2022
First submitted
3 Dec 2020
Last updated
28 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27776166

  • 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.

    PubMed 21826146

  • 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.

    PubMed 14654169

  • 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.

    PubMed 28512473

  • 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.

    PubMed 29391517

  • 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.

    PubMed 13679076

  • 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.

    PubMed 24520218

  • 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.

    PubMed 26904160

  • 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.

    PubMed 26968675

Questions about this trial

What is this clinical trial studying?

A study testing Stem Cell Support Formula in people with Knee Osteoarthritis, run by Regenexx, LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lower Extremity Function Scale (LEFS) change from baseline (time frame: Change from baseline to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04661267, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.

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