An interventional study of Stem Cell Support Formula and Placebo in Knee Osteoarthritis, sponsored by Regenexx, LLC. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-28.
Sponsored by Regenexx, LLC · Not applicable, Interventional, and Supportive care
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Regenexx, LLC is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula.
Lower Extremity Function Scale (LEFS) change from baseline
The difference between groups of the within patient mean change from baseline to 2 months.
Time frame: Change from baseline to 2 months
Minimal Clinically Important Difference (MCID) for LEFS
Percentage of patients meeting the MCID for LEFS at 2 months
Time frame: 2 months
Lower Extremity Function Scale (LEFS) change from baseline
The difference between groups of the within patient mean change from baseline to 1 month.
Time frame: Change from baseline to 1 month
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
Time frame: 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
Time frame: Change from baseline to 1 months
Minimal Clinically Important Difference (MCID) for IKDC
Percentage of patients meeting the MCID for IKDC at 2 months
Time frame: 2 months
Numeric Pain Score (NPS) change from baseline
The difference between groups of the within patient mean change from baseline to 1 month.
Time frame: 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.
Time frame: Change from baseline to 2 months
Minimal Clinically Important Difference (MCID) for NPS
Percentage of patients meeting the MCID for NPS at 2 months
Time frame: 2 months
Single Assessment Numeric Evaluation (SANE)-modified
The difference between groups for mean improvement scores at 1 month
Time frame: 1 month
Single Assessment Numeric Evaluation (SANE)-modified
The difference between groups for mean improvement scores at 2 months
Time frame: 2 months
Adverse events
Any complication or adverse event reported
Time frame: Thru 2 months
Additional medications or treatments
Any additional treatments or medications
Time frame: Thru 2 months
Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Regenexx, LLC