Adipose-derived SVF for the Treatment of Knee OA

Osteoarthritis is the main form of arthritis and affects over 20 million people in the United
States. In the knee it can cause severe pain, reduced functionality and increased stiffness
thus, a treatment that would reduce pain, increase function and reduce stiffness would be of
benefit to many people.

This study will collect and disassociate adipose tissue and inject the stromal vascular
fraction into the knee of the same patient. The study is controlled, randomized and
double-blinded with 2 SVF treatments (high and low dose) and a placebo control.

Inclusion Criteria:

- Grade II or Grade III osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade)
as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI.

- Study Subjects must have failed a minimum of at least two conservative therapies,
spanning a period of at least 3 months.

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

- Subjects will be in good health (ASA Class I-II) with a BMI < 35.

- Subjects must have continued pain in the knee despite conservative therapies for at
least 3 months.

- Subjects with unilateral disease must present with symptomatic knee pain using the
WOMAC subscale for pain.

- Subjects must speak, read and understand English.

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

Exclusion Criteria:

- Subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus
tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis
dissecans.

- Subjects who have had surgery of either knee within 6 months prior to the screening
visit.

- Subjects who have had a major injury to the targeted knee within 12 months prior to
enrolling in the study.

- Subjects who have had an injection in either knee in the prior 3 months, including
corticosteroids, viscosupplementation or platelet rich plasma (PRP).

- Subjects who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis,
avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia,
pes anserine bursitis, or neurogenic or vascular claudication.

- Subjects who have symptomatic OA of the hips, spine, or ankle that would interfere
with the evaluation of the treated knee.

- Subjects that are unwilling to stop taking prescription or over the counter pain
medication for 7 days prior to any visit

- Subjects that are allergic to lidocaine, epinephrine or valium

- Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be
stopped as prior to injection.

- Subjects with systemic immunosuppressant use within six (6) weeks from screening and
subjects with HIV/viral hepatitis.

- Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis

- Subjects that use any form of tobacco

- Women that are pregnant or planning to become pregnant during the study.

- Subjects on long term use of oral steroids

- History of any chemotherapy or radiation therapy of the targeted/treatment leg or
adipose harvest site.

- Subjects currently on worker's compensation