Clinical trial: A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment (NCT02370823)

Eligibility criteria:
Inclusion Criteria:

          1. Voluntary signature of the IRB approved Informed Consent

          2. Unilateral osteoarthritic male or female ages 35-85

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

          4. Physical examination consistent with osteoarthritis in one knee joint

          5. Restricted range of motion of the affected knee (<135 degrees in flexion and/or >0
             degrees of extension)

          6. Kellgren-Lawrence grade 2 or greater knee osteoarthritis with diagnostic MR imaging of
             the affected knee showing osteoarthritis

          7. Limited knee effusion in osteoarthritic knee (i.e. not more than 20 ml of visible
             joint fluid on ultrasound examination of the knee.)

          8. Normal range of motion of the unaffected knee

          9. No sign of pain, swelling, and/or functional disability of the unaffected knee

         10. No history of acute injury in the unaffected knee

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

        Exclusion Criteria:

          1. Knee injections of any type within 6 months prior to the study.

          2. 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)

          3. Quinolone or Statin induced myopathy/tendinopathy

          4. Symptomatic lumbar spine pathology (e.g. radicular pain)

          5. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh (i.e.
             evidence of complex regional pain syndrome or central sensitization with allodynia
             present on exam).

          6. Contraindications for MRI

          7. Tested positive or has been treated for a malignancy in the past five years or is
             suspected of having a malignancy or is currently undergoing radiation or chemotherapy
             treatment for a malignancy anywhere in the body, whether adjacent to or distant from
             the proposed injection site

          8. Condition represents a worker's compensation case

          9. Currently involved in a health-related litigation procedure

         10. Is pregnant

         11. Bleeding disorders

         12. Currently taking anticoagulant or immunosuppressive medication

         13. Allergy or intolerance to study medication

         14. Use of chronic opioid

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

        18) 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