Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis

Exclusion Criteria

• •1. Subjects whose knee pain is caused by:
• •i. unstable meniscal root tears or locked bucket handle meniscal tears ii. displaced meniscus tear iii. osteo chondritis dissecans iv. parameniscal, Baker's, or ganglion cysts v. lipoma arborescens vi. Hoffa's Pad Syndrome vii. acute ligament tears viii. diffuse edema ix. patellar mal-tracking or patellar dislocations
• •2. Outerbridge Scale Grade 0-I as diagnosed on MRI
• •3. Outerbridge Scale Grade IV where the full thickness lesion of the articular cartilage is greater than 4.0 cm in any direction, as diagnosed on MRI
• •4. Subjects with malignant neoplasms of the bone, cartilage, synovium or vasculature.
• •5. Subjects who have had surgery of either knee within 6 months prior to the surgery visit
• •6. Subjects who have had a major injury to either knee within 12 months prior to the surgery visit
• •7. Subjects who have had an injection into the intraarticular space of either knee in the prior 6 months, including corticosteroids, viscosupplementation, stromal vascular fraction (SVF), bone marrow stem cells, or platelet rich plasma
• •8. Subjects who have a diagnosis of gout with a flare in the past 12 months.
• •9. Subjects who have a diagnosis of Pes Anserine Bursitis with an event in the past 12 months.
• •10. Subjects who have had a diagnosed infection in the knee joint in the past 12 months.
• •11. Subject who have received a diagnosis of the following at any time: rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, fibromyalgia, or neurogenic or vascular claudication
• •12. Diagnosis of severe bone deformity defined as greater than 10 degrees of either varus or valgus deformity
• •13. Subjects that are unwilling to stop taking prescription or over the counter pain medication 7 days prior to any visit (except Day 2 Post Treatment Visit).
• •14. Subjects that are allergic to lidocaine, epinephrine or valium
• •15. Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as follows prior to injection; thrombolytics and anti-platelet medication including but not limited to Coumadin (warfarin) for 3 days, Plavix (colpidogrel) for 3 days, ASA/NSAIDs/fish oil supplements for 7 days, Xarelto® (rivaroxaban) for 24 hours
• •16. Subjects with systemic immunosuppressant use within 6 weeks from screening
• •17. Subjects with HIV or viral hepatitis
• •18. Subjects who have ever received a diagnosis of:
• •chondrocalcinosis, Paget's disease or Villonodular synovitis
• •19. Subjects that use any form of tobacco, including e-cigarettes, more than once a week over the most recent 1 year period
• •20. Women that are pregnant or planning to become pregnant during the study
• •21. Subjects on long term oral steroids defined as longer than a 2-week taper.
• •22. History of any chemotherapy or radiation therapy on either leg or adipose harvest site
• •23. Subjects currently on workers' compensation