Clinical trial: Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment (NCT02848027)

Eligibility criteria:
Inclusion Criteria:

          1. Voluntary signature of the IRB approved Informed Consent

          2. Unilateral or bilateral osteoarthritic male or female ages 35-85

          3. Pain, swelling, and/or functional disability in the affected knee consistent with
             osteoarthritis in the knee joint

          4. Physical examination consistent with osteoarthritis in one knee joint

          5. Kellgren-Lawrence grade 2 or greater 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…)

          6. Is independent, ambulatory, and can comply with all post-operative evaluations and
             visits

        Exclusion Criteria:

          1. Knee injections of any type within 3 months prior to the study.

          2. Knee surgery within 6 months prior to the study.

          3. 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)

          4. Quinolone or Statin induced myopathy/tendinopathy

          5. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh

          6. Contraindications for MRI

          7. Condition represents a worker's compensation case

          8. Currently involved in a health-related litigation procedure

          9. Is pregnant

         10. Bleeding disorders

         11. Currently taking anticoagulant or immunosuppressive medication

         12. Allergy or intolerance to study medication

         13. Use of chronic opioid

         14. Documented history of drug abuse within six months of treatment

         15. Any other condition, that in the opinion of the investigator, that would preclude the
             patient from enrollment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment