Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee

Exclusion Criteria

• •Pregnant or nursing, or planning on becoming pregnant during the study period.
• •Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results.
• •Significant clinical malalignment requiring follow-up full length, standing X-rays.
• •Orthopedic hardware or implantable devices anywhere in the body, other than dental.
• •Surgery on the index knee within 1 year of study enrollment.
• •Injections of any into the index knee within 3 months prior to study enrollment.
• •Locking, catching, give-away or another major mechanical symptom of the target knee.
• •Kellgren-Lawrence Grade 1 or-4 arthritis in the index knee.
• •History of intra-articular infection in the index knee.
• •History of superficial infection in the index knee within 6 months of study enrollment, or evidence of current superficial infection affecting the index knee.
• •History of falls requiring medical attention, or gait instability.
• •Abnormal hematology (complete blood count with differential), blood chemistry (Glucose, Calcium, Sodium, Potassium, Bicarbonate, Chloride, BUN, Creatinine, Anion Gap), or urinalysis screening laboratory results, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), , and CRP.. If the laboratory reports a single, non-clinically relevant, non-life-threatening result for any of these studies and is the only excluding factor it may be repeated 1 week later if the patient wishes. Normalization of that laboratory study will then be considered nonexclusionary. See Section 14.3, Appendix 3.
• •Body mass index (BMI) \> 40 kg/m2.
• •Taking anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix).
• •Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to avoid use of herbal therapies or supplements until at least 30 days following completion of the study drug treatment cycle (includes, but not limited to chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin).
• •Taking non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) without a stable dosing regimen for at least 4 weeks before baseline evaluation, or anticipating not remaining on a stable dose until at least 30 days following completion of the study drug treatment cycle.
• •Use of electrotherapy or acupuncture for OA, unless there is a stable regimen for at least 4 weeks before baseline assessment.
• •Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
• •On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids.
• •Current tobacco product use, including nicotine patch or other nicotine products.
• •Systemic inflammatory, rheumatological or connective tissue disorder including but not limited to rheumatoid arthritis, systemic sclerosis, system lupus erythematosus, and Ehlers-Danlos Syndrome.
• •Rheumatological or inflammatory disease of the knee or chondrocalcinosis/calcium pyrophosphate disease (CPPD), hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
• •Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.
• •Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension \> 90 mmHg diastolic and/or 180 mmHg systolic), neurologic (e.g. stroke, TIA) renal, hepatic, orthopedic (e.g. surgery on other weight bearing joints that will interfere with study, osteoporosis, acute lower body fractures), or endocrine disease (e.g. diabetes).
• •Vascular or neurological disorder affecting the index either lower limb.
• •History of cancer/malignancy with the exception of adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target knee within the last 5 years.
• •History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy.
• •Participation in a study of an experimental drug or medical device within 3 months of study enrollment.
• •Known allergy to local anesthetics of other components of the study drug.
• •Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures.
• •History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have use of medical marijuana within 30 days of study entry.
• •Any illness or condition which, in the investigators' judgement will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.