Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2021-02-03
2022-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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 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.
Placebo
The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Regenexx, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Centeno, MD
Role: PRINCIPAL_INVESTIGATOR
Regenexx, LLC and Centeno-Schultz Clinic
Locations
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Centeno-Schultz Clinic
Broomfield, Colorado, United States
Centeno-Schultz Clinic
Lone Tree, Colorado, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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RGX2020-RCT02
Identifier Type: -
Identifier Source: org_study_id