Correlating the OA Knee Microenvironment to Outcomes After Regenexx-SD Treatment: A Multi-Site Study
Correlating the OA Knee Microenvironment to Outcomes After Regenexx-SD Treatment: A Multi-Site Study
Multi-center study to include up to 600 subjects with knee osteoarthritis in unilateral or
 bilateral knees treated with Regenexx® SD in the osteoarthritic knee/s. Synovial fluid drawn
 from patients' knee/s prior to receiving Regenexx-SD treatment will be correlated with their
 clinical outcomes after treatment.
Initial study procedures include baseline evaluation of medical history, knee history, knee
 examination, medication use, MRI, and subject-reported outcomes.

 Each osteoarthritic subject will undergo withdrawal of knee joint synovial fluid for each
 knee being treated (0.3-0.5 ml) which will be analyzed by the research laboratory via
 multiplexed enzyme linked immunosorbent assay (ELISA) and dimethylmethylene blue assay (DMMB)
 at pre-injection (2-8 days before Regenexx-SD treatment). Documentation of osteoarthritic
 joint characteristics and injection procedure details will be recorded throughout the study.

 The unaffected knee joint will undergo no treatment, but bilateral knees may be treated.

 The objective of this study is to correlate the pre- Regenexx-SD treatment levels of
 pro-inflammatory cytokines, anti-inflammatory cytokines, matrix metalloproteinases, and
 catabolic articular cartilage breakdown products in the osteoarthritic knee synovial fluid
 microenvironment with 6 month post-treatment clinical outcomes. This data will be used to
 establish a predictive a priori testing "model" to determine if a patient is a good candidate
 for the Regenexx-SD treatment based on their initial osteoarthritic knee synovial fluid
 microenvironment phenotype. It may also be used to determine if the micro-environment can be
 altered to improve outcome before receiving Regenexx-SD.

 Incidence of post-operative complications, adverse events, re-injections, and surgical
 intervention and change in pain score will be considered while determining these direct and
 indirect associations upon completion of the Regenexx-SD treatment.

 Components of the synovial fluid will be correlated to post-treatment clinical outcomes,
 which include several self-reported questionnaires as well as assessment of post-injection
 complications, adverse events, re-injections and surgical interventions. Patient reported
 questionnaires include IKDC Subjective Knee Evaluation, Lower Extremity Function Scale, Pain
 Scales and a Modified Single Assessment Numeric Evaluation (SANE).
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:

 -  7) Knee injections of any type within 3 months prior to the study. 8) Knee surgery
 within 6 months prior to the study.

 9) Patient undergoing lavage with treatment

 10) 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) 11) Quinolone or statin-induced
 myopathy/tendinopathy 12) Severe neurogenic inflammation of the cutaneous nerves about
 the knee or thigh 13) Contraindications for MRI 14) Condition represents a worker's
 compensation case 15) Currently involved in a health-related litigation procedure 16)
 Is pregnant 17) Bleeding disorders 18) Currently taking anticoagulant or
 immunosuppressive medication 19) Allergy or intolerance to study medication 20) Use of
 chronic opioid 21) Documented history of drug abuse within six months of treatment 22)
 Any other condition, that in the opinion of the investigator, that would preclude the
 patient from enrollment