Randomized Trial of Regenexx Stem Cell Support Formula

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04661267
• Other study ID #: RGX2020-RCT02
• Status: Completed
• Phase: N/A
• Start date: February 3, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2022
• Source: Regenexx, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Centeno-Schultz Clinic	Broomfield	Colorado
United States	Centeno-Schultz Clinic	Lone Tree	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Regenexx, LLC

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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