Recruiting

Phase 2

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

Sponsor:

Ageless Biotech, Inc.

Code:

NCT06485843

Conditions

Osteoarthritis

Osteo Arthritis Knee

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

OA-SYS

Study Details

Brief 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.

Conditions

Osteoarthritis

Osteo Arthritis Knee

Study ID

NCT06485843

Start date

May 21, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OA-SYS

Treatment with OA-SYS

Interventions

OA-SYS

OA-SYS is made of several types of cells obtained from fat tissue for the treatment of osteoarthritis.

Primary outcome measure

Presence of Adverse Events [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

Vince Liguori

847-561-0217 vince@agebiomed.com

Mukesh Kumar, PhD RAC

2407504893 mkumar@fdamap.com

Locations

Orthopedic & Sports Medicine Institute of Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89117

More Information

Sponsor

Ageless Biotech, Inc.

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ageless Biotech, Inc. on 2025-09-18.