The Safety and Efficacy of XytriX (Umbilical Cord-Derived Mesenchymal Stem Cells) in the Treatment of Knee Osteoarthritis

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTricelX Inc.

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mesenchymal Stem Cell Injection

    Biological/Vaccine

    Subjects will receive an intra-articular injection of mesenchymal stem cells derived from umbilical cord tissue

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: XytriX 30 million cells intra-articular injectionExperimental treatment 1 intervention
Group B: XytriX 10 million cells IA InjectionExperimental treatment 1 intervention
Group C: XytriX 50 million cells IA doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Knee Injury and Osteoarthritis Outcome Score

Scores are transformed into a 0-100 point scale. 0 means extreme problems and 100 means no problems.

Time frame
24 months
2

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.

Time frame
24 months

Secondary outcomes

1

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.

Time frame
24 months
2

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

Time frame
24 months
3

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.

Time frame
24 months
4

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.

Time frame
24 months

Other outcomes

Sponsors and contacts

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