A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment
A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment
The primary objective of this study is to determine the levels of proteins and/or cellular
 components of the synovial fluid that are indicative of microenvironment phenotypes of the
 osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks
 post-Regenexx® SD treatment.
The primary objective of this study is to determine the levels of proteins and/or cellular
 components of the synovial fluid that are indicative of microenvironment phenotypes of the
 osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks
 post-Regenexx SD treatment (day 0).

 Secondary objective is an evaluation of possible direct and/or indirect associations between
 the measured levels of proteins and/or cellular components of the synovial fluid in the
 osteoarthritic knee joint with the administration of the Regenexx SD treatment. The secondary
 objective will include MRI evidence of cartilage repair; incidence of post-operative
 complications, adverse events, re-injections, and surgical intervention; change in pain score
 and use of pain medications.
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