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

Launched by AGELESS BIOTECH, INC. · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called OA-SYS for people who have moderate to severe osteoarthritis in their knee. Osteoarthritis is a condition that causes pain and stiffness in the joints, and the purpose of this study is to see how safe this treatment is and how well patients can tolerate it. The trial is currently recruiting participants, and anyone between the ages of 35 to 75 who is generally healthy and has a specific level of osteoarthritis (as measured by a scoring system) may be eligible to join.

If you decide to participate, you'll need to follow certain guidelines, such as avoiding specific treatments during the study. The trial will involve regular visits where you'll be monitored for your health and any side effects. It's important to know that some people may not qualify if they have certain medical conditions, have had recent surgeries, or are taking specific medications. Overall, this study aims to help improve treatment options for people suffering from knee osteoarthritis.

Gender

ALL

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.