Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT04661267
Status:
COMPLETED
Last Update Posted:
2022-12-28
First Post:
2020-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Trial of Regenexx Stem Cell Support Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-27', 'studyFirstSubmitDate': '2020-12-03', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower Extremity Function Scale (LEFS) change from baseline', 'timeFrame': 'Change from baseline to 2 months', 'description': 'The difference between groups of the within patient mean change from baseline to 2 months.'}, {'measure': 'Minimal Clinically Important Difference (MCID) for LEFS', 'timeFrame': '2 months', 'description': 'Percentage of patients meeting the MCID for LEFS at 2 months'}], 'secondaryOutcomes': [{'measure': 'Lower Extremity Function Scale (LEFS) change from baseline', 'timeFrame': 'Change from baseline to 1 month', 'description': 'The difference between groups of the within patient mean change from baseline to 1 month.'}, {'measure': 'International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline', 'timeFrame': 'Change from baseline to 2 months', 'description': 'The difference between groups of the within patient mean change from baseline to 2 months'}, {'measure': 'International Knee Documentation Committee (IKDC) Subjective Knee Evaluation change from baseline', 'timeFrame': 'Change from baseline to 1 months', 'description': 'The difference between groups of the within patient mean change from baseline to 1 months'}, {'measure': 'Minimal Clinically Important Difference (MCID) for IKDC', 'timeFrame': '2 months', 'description': 'Percentage of patients meeting the MCID for IKDC at 2 months'}, {'measure': 'Numeric Pain Score (NPS) change from baseline', 'timeFrame': 'Change from baseline to 1 months', 'description': 'The difference between groups of the within patient mean change from baseline to 1 month.'}, {'measure': 'Numeric Pain Score (NPS) change from baseline', 'timeFrame': 'Change from baseline to 2 months', 'description': 'The difference between groups of the within patient mean change from baseline to 2 months.'}, {'measure': 'Minimal Clinically Important Difference (MCID) for NPS', 'timeFrame': '2 months', 'description': 'Percentage of patients meeting the MCID for NPS at 2 months'}, {'measure': 'Single Assessment Numeric Evaluation (SANE)-modified', 'timeFrame': '1 month', 'description': 'The difference between groups for mean improvement scores at 1 month'}, {'measure': 'Single Assessment Numeric Evaluation (SANE)-modified', 'timeFrame': '2 months', 'description': 'The difference between groups for mean improvement scores at 2 months'}, {'measure': 'Adverse events', 'timeFrame': 'Thru 2 months', 'description': 'Any complication or adverse event reported'}, {'measure': 'Additional medications or treatments', 'timeFrame': 'Thru 2 months', 'description': 'Any additional treatments or medications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '27776166', 'type': 'BACKGROUND', '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.'}, {'pmid': '21826146', 'type': 'BACKGROUND', '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.'}, {'pmid': '14654169', 'type': 'BACKGROUND', '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.'}, {'pmid': '28512473', 'type': 'BACKGROUND', 'citation': "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': '29391517', 'type': 'BACKGROUND', '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.'}, {'pmid': '13679076', 'type': 'BACKGROUND', '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.'}, {'pmid': '24520218', 'type': 'BACKGROUND', '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.'}, {'pmid': '26904160', 'type': 'BACKGROUND', '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.'}, {'pmid': '26968675', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTreatment 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.\n\nControl 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Voluntary signature of the IRB approved Informed Consent\n2. Unilateral or bilateral osteoarthritic male or female ages 18-80\n3. Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint\n4. Physical examination consistent with osteoarthritis in knee joint\n5. 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.)\n6. Minimum of 3/10 on NPS approximately 3 days per week\n7. Is independent, ambulatory, and can comply with all post-operative evaluations and visits\n\n Exclusion Criteria:\n8. Previously taken the Regenexx Stem Cell Support Formula\n9. Receiving active knee treatment or any knee injections of any type within 3 months prior to the study (steroids, biologics, etc)\n10. Knee surgery within 6 months prior to the study\n11. Currently taking or history of taking products that contain curcuminoid extract within the last 2 weeks\n12. Dependent on NSAIDs or acetaminophen for exercise or daily activities\n13. Currently taking or previously taken fish oil in the last 2 weeks\n14. Currently taking or previously taking MSM or glucosamine in the last 2 weeks\n15. Diabetic\n16. 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)\n17. Quinolone or statin-induced myopathy/tendinopathy\n18. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh\n19. Contraindications for MRI\n20. Condition represents a worker's compensation case\n21. Currently involved in a health-related litigation procedure\n22. Is pregnant or breastfeeding\n23. Currently taking immunosuppressive medication\n24. Allergy or intolerance to study medication\n25. Use of chronic opioid\n26. Documented history of drug abuse within six months of treatment\n27. Blood clotting disorder, taking an anticoagulant or history of cardiovascular disease\n28. Has asthma\n29. History of prostate cancer\n\n29\\) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment including current supplement use"}, 'identificationModule': {'nctId': 'NCT04661267', 'briefTitle': 'Randomized Trial of Regenexx Stem Cell Support Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regenexx, LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Trial of Regenexx Stem Cell Support Formula', 'orgStudyIdInfo': {'id': 'RGX2020-RCT02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplement formula', 'description': '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.', 'interventionNames': ['Dietary Supplement: Stem Cell Support Formula']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo formula', 'description': '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.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Stem Cell Support Formula', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Supplement formula']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula.', 'armGroupLabels': ['Placebo formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80021', 'city': 'Broomfield', 'state': 'Colorado', 'country': 'United States', 'facility': 'Centeno-Schultz Clinic', 'geoPoint': {'lat': 39.92054, 'lon': -105.08665}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United States', 'facility': 'Centeno-Schultz Clinic', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}], 'overallOfficials': [{'name': 'Christopher Centeno, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regenexx, LLC and Centeno-Schultz Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regenexx, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}