Stem Cell Support Formula Study for Patients with Knee Osteoarthritis

Patients must be able to visit the clinic in Broomfield, CO to see if they are a candidate and for all study visits (evaluation and 2-month visit).

Our Research Team is conducting a study to understand the effects of the Regenexx Stem Cell Support Formula on joint health. Participants in the study will be randomly assigned to one of 2 groups, either to receive the real supplement formula or a placebo supplement. Patients will take 1 ounce (1 capful) of the liquid supplement provided for 2 months. Participants will keep a daily diary to document doses and pain medications taken. After taking the supplement for 1-month, participants will complete online surveys and have a check-in with someone from our research team. At 2-months, participants will visit with one of our research staff to complete another set of questionnaires and final study activities. They will also be told at that time whether they had been assigned to the real or placebo supplement. If in the placebo group, you will receive 2 real bottles of supplement at no cost.

Candidates must meet ALL of the following (tick if yes):

  • 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 evaluations and visits

Candidates will be excluded if they meet ANY of the following (tick if no):

  • 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
  • History of prostate cancer
  • Has asthma
  • Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment including current supplement use

*Recruiting local patients only

If you are interested in seeing if you are a candidate for participating in this study, please email Ehren Dodson, PhD, Clinical Research Director, at [email protected] or call 720-287-7199.

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CONTACT INFORMATION

Address

9035 Wadsworth Pkwy #1000
Westminster, CO 80021

Phone

*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.

Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.

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