Randomized Trial of Regenexx Stem Cell Support Formula

NCT04661267 | Completed

• 1 other identifier: RGX2020-RCT02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Lower Extremity Function Scale (LEFS) change from baseline

  Change from baseline to 1 month

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

  Change from baseline to 2 months

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

  Change from baseline to 1 months

• Minimal Clinically Important Difference (MCID) for IKDC

  2 months

• Numeric Pain Score (NPS) change from baseline

  Change from baseline to 1 months

Study Arms (2)

Supplement formula

EXPERIMENTAL

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

Placebo formula

PLACEBO COMPARATOR

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

Interventions

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.

Supplement formula

Placebo DIETARY_SUPPLEMENT

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

Placebo formula

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regenexx, LLC: lead

Study Sites (2)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

Location

Centeno-Schultz Clinic

Lone Tree, Colorado, 80124, United States

Location

Related Publications (9)

• 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.

  PMID: 27776166 BACKGROUND

• 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.

  PMID: 21826146 BACKGROUND

• 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.

  PMID: 14654169 BACKGROUND

• 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.

  PMID: 28512473 BACKGROUND

• 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.

  PMID: 29391517 BACKGROUND

• 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.

  PMID: 13679076 BACKGROUND

• 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.

  PMID: 24520218 BACKGROUND

• 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.

  PMID: 26904160 BACKGROUND

• 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.

  PMID: 26968675 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Christopher Centeno, MD

  Regenexx, LLC and Centeno-Schultz Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: February 3, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)