An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint

Inclusion Criteria:

• Adults between the ages of 35 - 75 years Body Mass Index (BMI) less than 39 kg/m2

• Ambulatory and in good general health

• Willing and able to comply with the study procedures and visit schedules and able tofollow verbal and written instructions

• Willing to abstain from use of protocol-restricted treatments from Screening throughEnd-of-Treatment

• Kellgren-Lawrence grading scale score of 3 or 4 for OA of the knee

• No clinically significant abnormalities observed in medical history, physical examvital signs, and laboratory assessments

• For females of reproductive potential: use of effective contraception for at least 1month prior to screening and agreement to use such a method till end of the studyperiod and negative pregnancy test

• For males of reproductive potential: use of condoms and other methods to ensureeffective contraception

Exclusion Criteria:

• Known or suspected infection of the target joint

• Subjects with surgery for OA in the target joint

• Subject with reactive arthritis, rheumatoid arthritis, psoriatic arthritis,ankylosing spondylitis, or arthritis associated with inflammatory bowel disease

• Subject with myocardial infarction, congestive heart failure, and other severe heartdisease or hypertension (or medical history of hypertension) that are not controlledbelow 140/90 mmHg even with treatment with more than three antihypertensive drugs

• Subject with serious medical conditions other than cardiovascular disease

• Subject with, or with a medical history of autoimmune diseases

• Subject with an infection that requires parenteral antibiotic administration within 30 days prior to screening

• Subject with a medical history of mental disorder or epilepsy

• Subject abuse alcohol 10 times a week or smoke 25 cigarettes a day

• Subject who was diagnosed with cancer within 5 years before screening

• Subject who participated in another clinical trial within 6 months prior to thescreening of this clinical trial

• Subject who was administered with immunosuppressants such as cyclosporin A orazathioprine within 6 weeks prior to the screening

• Subject who had intra-articular administration such as sodium hyaluronate injectionswithin 6 months prior to the screening

• Clinical findings consistent with active infection or crystal disease in the indexjoint within 1 month prior to the screening

• History of fracture in the index limb or fracture with sequelae within 12 monthsprior to the screening

• Joint instability or history of acute dislocation within 12 months prior to thescreening

• Planned or anticipated surgery of the joint during the study period

• Presence of surgical hardware or other foreign body in the index joint

• Surgery or arthroscopy of the index joint within 12 months of screening

• Intra-articular treatment of any joint with any of the following agents within 6months prior to the screening: Any corticosteroid preparation (investigational ormarketed), any biologic agent (e.g., platelet rich plasma (PRP) injection, stemcells, prolotherapy, amniotic fluid injection)

• Treatment of the index joint with any investigational therapy within 6 months priorto the screening

• Serious life-threatening conditions

• Allergies to anesthesia

• Subject who is breastfeeding.