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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
400
OA-SYS is made of several types of cells obtained from fat tissue for the treatment of osteoarthritis.
Orthopedic & Sports Medicine Institute of Las Vegas
Las Vegas, Nevada, United States
RECRUITINGPresence of Adverse Events
Presence of adverse events in less than 5% of the study population, as a measure of safety
Time frame: 52 weeks
Change in NSAIDs Use
Change in NSAIDS use, until study completion
Time frame: 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.
Time frame: 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.
Time frame: 52 weeks
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