RecruitingOsteoarthritisOsteo Arthritis Knee

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

Eligible age

35–75 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

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.

Sponsor: Ageless Biotech, Inc.

✓ 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

✕ 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

Las Vegas

Source: ClinicalTrials.gov · NCT06485843 · last updated 2025-09-18