Actively Recruiting
An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint
Led by Ageless Biotech, Inc. · Updated on 2025-09-18
400
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults between the ages of 35 and 75 years with a Body Mass Index (BMI) less than 39 kg/m2
- Ambulatory and in good general health
- Willing and able to comply with study procedures and visit schedules
- Willing to avoid protocol-restricted treatments from screening through end-of-treatment
- Kellgren-Lawrence grade 3 or 4 for osteoarthritis of the knee
- No significant abnormalities in medical history, physical exam, vital signs, or lab tests
- Females of reproductive potential must use effective contraception for at least 1 month before screening and during the study; negative pregnancy test required
- Males of reproductive potential must use condoms or other effective contraception methods
You will not qualify if you...
- Infection of the target knee joint
- Previous surgery for osteoarthritis in the target knee joint
- Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis related to inflammatory bowel disease
- Uncontrolled heart disease or hypertension despite treatment with more than three antihypertensive drugs
- Serious medical conditions other than cardiovascular disease
- Autoimmune diseases or history of such diseases
- Infection requiring intravenous antibiotics within 30 days before screening
- History of mental disorder or epilepsy
- Alcohol abuse (10 times a week) or smoking 25 cigarettes a day
- Cancer diagnosis within 5 years before screening
- Participation in another clinical trial within 6 months before screening
- Use of immunosuppressants such as cyclosporin A or azathioprine within 6 weeks before screening
- Intra-articular injections like sodium hyaluronate within 6 months before screening
- Active infection or crystal disease in the index joint within 1 month before screening
- Fracture in the index limb or related complications within 12 months before screening
- Joint instability or acute dislocation within 12 months before screening
- Planned or expected joint surgery during the study
- Presence of surgical hardware or foreign body in the index joint
- Surgery or arthroscopy of the index joint within 12 months before screening
- Intra-articular treatment with corticosteroids, biologics, or investigational therapy within 6 months before screening
- Serious life-threatening conditions
- Allergies to anesthesia
- Currently breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Orthopedic & Sports Medicine Institute of Las Vegas
Las Vegas, Nevada, United States, 89117
Actively Recruiting
Research Team
V
Vince Liguori
CONTACT
M
Mukesh Kumar, PhD RAC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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