Clinical trial NCT06485843: An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Osteoarthritis
Osteo Arthritis Knee
Lead sponsor: Ageless Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 400
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of Adverse Events
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in NSAIDs Use
timeFrame: 52 weeks
measure: Change in The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 52 weeks
measure: Change in the Visual Analog Scale (VAS)
timeFrame: 52 weeks
Other outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: 52 weeks
measure: Incidence of withdrawals due to adverse events (AEs)
timeFrame: 52 weeks
Locations:
city: Las Vegas
country: United States
facility: Orthopedic & Sports Medicine Institute of Las Vegas
state: Nevada
Study officials:
References: