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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 to follow verbal and written instructions.

• - Willing to abstain from use of protocol-restricted treatments from Screening through End-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 exam vital signs, and laboratory assessments.

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

• - For males of reproductive potential: use of condoms and other methods to ensure effective 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 heart disease or hypertension (or medical history of hypertension) that are not controlled below 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 the screening of this clinical trial.

• - Subject who was administered with immunosuppressants such as cyclosporin A or azathioprine within 6 weeks prior to the screening.

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

• - Clinical findings consistent with active infection or crystal disease in the index joint within 1 month prior to the screening.

• - History of fracture in the index limb or fracture with sequelae within 12 months prior to the screening.

• - Joint instability or history of acute dislocation within 12 months prior to the screening.

• - 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 6 months prior to the screening: Any corticosteroid preparation (investigational or marketed), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection) - Treatment of the index joint with any investigational therapy within 6 months prior to the screening.

• - Serious life-threatening conditions.

• - Allergies to anesthesia.

• - Subject who is breastfeeding.

PURPOSE OF THE STUDY The goal of this clinical trial is to evaluate the safety and tolerability of a treatment called OA-SYS for moderate to severe osteoarthritis (OA) of the knee. Osteoarthritis is a common condition that affects the joints and can cause significant pain and disability, especially in older adults. The study aims to see if OA-SYS is a safe and effective treatment option for people with knee osteoarthritis. STUDY TREATMENT.Participants in this study will receive the OA-SYS treatment, which involves the use of adult stem cells (ASCs). The main questions the study aims to answer are:

• - Is OA-SYS safe and well-tolerated by participants with moderate to severe knee osteoarthritis? - Does OA-SYS help reduce the symptoms and improve the function of the knee joint? Participants will: - Receive the OA-SYS treatment, which includes adult stem cells, administered to the knee joint.

• - Attend regular clinic visits for check-ups and monitoring.

• - Report any side effects or changes in their condition throughout the study period.

RANDOMIZATION AND BLINDING This is a phase II open-label clinical trial, blinding is not applicable to this study.

Arms

Experimental: OA-SYS

Treatment with OA-SYS

Interventions

Drug: - OA-SYS

OA-SYS is made of several types of cells obtained from fat tissue for the treatment of osteoarthritis.