About this trial
This study aims to study the safety and efficacy of XytriX, an umbilical cord-derived stem cell product, in the treatment of Grade I-IV knee osteoarthritis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Mesenchymal Stem Cell Injection
Biological/VaccineSubjects will receive an intra-articular injection of mesenchymal stem cells derived from umbilical cord tissue
Treatment groups
Trial outcomes
Primary outcomes
Knee Injury and Osteoarthritis Outcome Score
Scores are transformed into a 0-100 point scale. 0 means extreme problems and 100 means no problems.
Western Ontario and McMaster Universities Osteoarthritis Index
Items are typically scored on a 0-4 Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Lower scores indicate better outcomes, while higher scores indicate worse pain, stiffness, and functional limitations.
Secondary outcomes
Visual Analog Pain Score
The Visual Analog Scale (VAS) is a 100mm horizontal line anchored by "no pain" (0mm) and "worst pain imaginable" (100mm) used to measure pain intensity. Patients mark the line, and the distance in millimeters provides a 0-100 score.
KOOS Sub-Scale
Change from baseline in all KOOS subscales (pain, symptoms, activities of daily living, sport and recreation, quality of life). The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item, self-administered questionnaire assessing five distinct subscales for knee health: Pain, Symptoms, Daily Living Activities (ADL), Sport/Recreation, and Quality of Life. It ranges from 0 (worst) to 100 (best) and is used to measure short- and long-term consequences of knee injury
Short Form-36 (SF-36)
This is a widely used, patient-reported survey measuring health-related quality of life across eight domains, including physical, emotional, and social functioning. It consists of 36 items, typically assessing the past four weeks, used to calculate physical (PCS) and mental (MCS) health summary scores ranging from 0 to 100. Items are transformed into a 0-100 scale, where higher scores represent better health.
Timed Up and Go Test
The Timed Up and Go (TUG) test is a simple, quick assessment used to measure an individual's balance, functional mobility, and fall risk. It requires the person to rise from a chair, walk 3 meters (10 feet), turn around, walk back, and sit down. A result of under 10-12 seconds is typically considered normal, while longer times indicate increasing fall risk.
Sponsors and contacts
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