Status:
COMPLETED
Randomized Trial of Regenexx Stem Cell Support Formula
Lead Sponsor:
Regenexx, LLC
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 he...
Detailed 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 mont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04661267
Start Date
February 3 2021
End Date
October 31 2022
Last Update
December 28 2022
Active Locations (2)
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1
Centeno-Schultz Clinic
Broomfield, Colorado, United States, 80021
2
Centeno-Schultz Clinic
Lone Tree, Colorado, United States, 80124