An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint (OA-SYS-01)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Osteo Arthritis Knee
• Intervention / Treatment: Drug: OA-SYS

Detailed Description

PURPOSE OF THE STUDY The goal of this clinical trial is to evaluate the safety and tolerability of a treatment called OA-SYS for moderate to severe osteoarthritis (OA) of the knee. Osteoarthritis is a common condition that affects the joints and can cause significant pain and disability, especially in older adults. The study aims to see if OA-SYS is a safe and effective treatment option for people with knee osteoarthritis.

STUDY TREATMENT

Participants in this study will receive the OA-SYS treatment, which involves the use of adult stem cells (ASCs). The main questions the study aims to answer are:

• Is OA-SYS safe and well-tolerated by participants with moderate to severe knee osteoarthritis?
• Does OA-SYS help reduce the symptoms and improve the function of the knee joint?

Participants will:

• Receive the OA-SYS treatment, which includes adult stem cells, administered to the knee joint.
• Attend regular clinic visits for check-ups and monitoring.
• Report any side effects or changes in their condition throughout the study period.

RANDOMIZATION AND BLINDING This is a phase II open-label clinical trial, blinding is not applicable to this study.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Vince Liguori; Phone Number: 847-561-0217; Email: vince@agebiomed.com
• Study Contact Backup: Name: Mukesh Kumar, PhD RAC; Phone Number: 2407504893; Email: mkumar@fdamap.com

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • Recruiting
      • Orthopedic & Sports Medicine Institute of Las Vegas
      • Contact: Randa Bascharon, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OA-SYS; Treatment with OA-SYS	Drug: OA-SYS; OA-SYS is made of several types of cells obtained from fat tissue for the treatment of osteoarthritis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Adverse Events	Presence of adverse events in less than 5% of the study population, as a measure of safety	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NSAIDs Use	Change in NSAIDS use, until study completion	52 weeks
Change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC)	The WOMAC score is used in clinical trials to measure the condition of patients with osteoarthritis. It's a patient-reported outcome measure where 0 represents the worst possible score and 100 represents the best possible score. A higher score indicates worse pain, stiffness, and functional limitations.	52 weeks
Change in the Visual Analog Scale (VAS)	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain". A lower scale indicates better progress, which indicates less pain.	52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	TEAEs are defined as adverse events with an onset on or after the time of first administration of the treatment.	52 weeks
Incidence of withdrawals due to adverse events (AEs)	Reported withdrawals from the study due to adverse events, as a measure of safety.	52 weeks

Collaborators and Investigators

• Sponsor: Ageless Biotech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: OA-SYS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No