Actively Recruiting
An Open Label Phase IIb 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
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of OA-SYS, a treatment for moderate to severe osteoarthritis (OA) of the knee joint. OA is a common condition that causes joint pain and disability, particularly in older adults. This phase II open-label clinical trial aims to determine if OA-SYS, which uses adult stem cells derived from fat tissue, is a safe and potentially helpful option for people suffering from knee OA. Participants will receive the OA-SYS treatment through administration of adult stem cells directly into the knee joint. This study does not use a placebo or blinding, and participants will attend regular clinic visits for monitoring. Throughout the study, participants will report any side effects or changes in their knee condition to help researchers understand the treatment's safety and tolerability. During their participation, individuals will undergo evaluations including physical exams, vital sign checks, and laboratory tests. Researchers will monitor adverse events over 52 weeks and assess changes in pain levels and knee function using tools like the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Visual Analog Scale (VAS). Participants will be followed for a year to closely observe the treatment's effects and safety.
CONDITIONS
Brief 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 abstain from restricted treatments from screening through end-of-treatment
- Kellgren-Lawrence grading scale score of 3 or 4 for knee osteoarthritis
- No clinically significant abnormalities in medical history, physical exam, vital signs, or lab tests
- Females of reproductive potential must use effective contraception and have a negative pregnancy test
- Males of reproductive potential must use condoms or other effective contraception methods
You will not qualify if you...
- Known or suspected infection of the target knee joint
- Previous surgery for osteoarthritis in the target joint
- Presence of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis related to inflammatory bowel disease
- History of severe heart disease or uncontrolled hypertension despite treatment
- Serious medical conditions other than cardiovascular disease
- Current or history of autoimmune diseases
- Recent infection requiring intravenous antibiotics within 30 days
- History of mental disorder or epilepsy
- Regular alcohol abuse or heavy smoking
- Cancer diagnosis within 5 years prior to screening
- Participation in another clinical trial within 6 months
- Use of immunosuppressants within 6 weeks prior to screening
- Intra-articular injections such as corticosteroids or biologics within 6 months
- Active infection or crystal disease in the joint within 1 month
- History of fracture or joint instability in the affected limb within 12 months
- Planned joint surgery during the study period
- Presence of surgical hardware or foreign body in the joint
- Recent joint surgery or arthroscopy within 12 months
- Treatment with investigational therapy in the index joint within 6 months
- Life-threatening conditions or allergies to anesthesia
- Currently breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive the OA-SYS treatment, which involves adult stem cells administered to the knee joint. Regular clinic visits are conducted for check-ups and monitoring during this period.
Regular clinic visits for check-ups and monitoring
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
M
Mukesh Kumar, PhD RAC
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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