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

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.

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.