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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Centeno, MD | Regenexx, LLC and Centeno-Schultz Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centeno-Schultz Clinic | Broomfield | Colorado | 80021 | United States | ||
| Centeno-Schultz Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27776166 | Background | 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. | |
| 21826146 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo | Dietary Supplement | The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula. |
|
The difference between groups of the within patient mean change from baseline to 2 months |
| 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 | Change from baseline to 1 months |
| Minimal Clinically Important Difference (MCID) for IKDC | Percentage of patients meeting the MCID for IKDC at 2 months | 2 months |
| 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 |
| 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 |
| Minimal Clinically Important Difference (MCID) for NPS | Percentage of patients meeting the MCID for NPS at 2 months | 2 months |
| Single Assessment Numeric Evaluation (SANE)-modified | The difference between groups for mean improvement scores at 1 month | 1 month |
| Single Assessment Numeric Evaluation (SANE)-modified | The difference between groups for mean improvement scores at 2 months | 2 months |
| Adverse events | Any complication or adverse event reported | Thru 2 months |
| Additional medications or treatments | Any additional treatments or medications | Thru 2 months |
| Lone Tree |
| Colorado |
| 80124 |
| United States |
| 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. |
| 14654169 | 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. |
| 28512473 | 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. |
| 29391517 | 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. |
| 13679076 | 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. |
| 24520218 | 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. |
| 26904160 | 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. |
| 26968675 | 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. |
| D012216 |
| Rheumatic Diseases |