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

Inclusion Criteria:

1. Bilateral or unilateral knee osteoarthritis as diagnosed on pre-op MRI using theOuterbridge Cartilage Classification as Grade II, Grade III, or Grade IV with fullthickness lesion of the articular cartilage is less than 4.0 cm in any direction

2. Kellgren and Lawrence score grade 2-4 as diagnosed on X-Ray

3. Index knee must present with a score ≥8 using the WOMAC pain scale (A1 subscale, 20total points)

4. Study Subjects must be willing to voluntarily give written Informed Consent toparticipate in the study and sign the Health Insurance Portability andAccountability Act (HIPAA) authorization before any study procedures are performed

5. Males and females 35-85 years old

6. Subjects with BMI ≥22 and ≤ 37

7. Subjects must speak, read and understand English

8. Subjects must be able to return for multiple follow-up visits

9. Subjects must have failed at least two conservative therapies for treatment of kneeOA within the last 24 months (2 years), with one or more of the failed conservativetherapies being from a-f:

10. Physical Therapy: 6 week course of treatment

11. Exercise Therapy: 6 week course of treatment

12. Viscosupplementation injection in the knee for OA pain

13. Steroid injection in the knee for OA pain

14. Platelet-Rich Plasma (PRP) injection in the knee for OA pain

15. Arthroscopic surgery including microfracture and/or debridement

16. Braces or other support devices: therapy tried for at least 2 weeks

17. Over the Counter (OTC) pain medication including NSAIDS, Acetaminophen, ASA:therapy tried for at least 2 weeks

18. Prescription pain medication: therapy tried for at least 1 weeks

19. Modification of Activities of Daily Living (ADL): therapy tried for at least 2weeks

20. Topical applications to the knee for OA pain: therapy tried for at least 2weeks

21. Supplements including glucosamine sulfate and chondroitin sulfate: therapytried for at least 4 weeks

22. Ice/Heat regimen: therapy tried for at least 2 weeks

Exclusion Criteria:

1. Subjects whose knee pain is caused by: i. unstable meniscal root tears or locked bucket handle meniscal tears ii. displacedmeniscus tear iii. osteo chondritis dissecans iv. parameniscal, Baker's, or ganglioncysts 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 articularcartilage 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 surgeryvisit

6. Subjects who have had a major injury to either knee within 12 months prior to thesurgery visit

7. Subjects who have had an injection into the intraarticular space of either knee inthe prior 6 months, including corticosteroids, viscosupplementation, stromalvascular 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 12months.

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: rheumatoidarthritis, 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 eithervarus or valgus deformity

13. Subjects that are unwilling to stop taking prescription or over the counter painmedication 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 cannotbe stopped as follows prior to injection; thrombolytics and anti-platelet medicationincluding 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 weekover 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 harvestsite

23. Subjects currently on workers' compensation