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

Phase 2

Recruiting

• Conditions: Osteoarthritis; Osteo Arthritis Knee
• Interventions: Drug: OA-SYS

• Registration Number: NCT06485843
• Lead Sponsor: Ageless Biotech, Inc.

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.

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 Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-07-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03
• Study Start: 2025-04-02
• Primary Completion: 2028-03-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OA-SYS	OA-SYS	Treatment with OA-SYS

Primary Outcome Measures

Name	Time	Method
Presence of Adverse Events	52 weeks	Presence of adverse events in less than 5% of the study population, as a measure of safety

Secondary Outcome Measures

Name	Time	Method
Change in NSAIDs Use	52 weeks	Change in NSAIDS use, until study completion
Change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC)	52 weeks	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.
Change in the Visual Analog Scale (VAS)	52 weeks	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.

Trial Locations

Locations (1)

Orthopedic & Sports Medicine Institute of Las Vegas; 🇺🇸 Las Vegas, Nevada, United States