an study to evaluate safety and tolerability of oa-sys in subjects with moderate to severe osteoarthritis of the knee joint

Conditions: Osteoarthritis; Osteo Arthritis Knee

Summary: this study is being conducted to evaluate the safety and tolerability of oa-sys in patients with moderate to severe oa 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.

Eligibility criteria:
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.