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

Ageless Biotech, Inc.

Status and phase

Enrolling

Phase 2

Conditions

Osteoarthritis

Osteo Arthritis Knee

Treatments

Drug: OA-SYS

Study type

Interventional

Funder types

Industry

Identifiers

NCT06485843

OA-SYS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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.