RecruitingPhase 2NCT06485843

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

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

Sponsor

Ageless Biotech, Inc.

Enrollment

400 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

Osteo Arthritis Knee Osteoarthritis

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.

Eligibility

Min Age: 35 YearsMax Age: 75 Years

Inclusion Criteria8

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 Criteria24

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.