A Phase 1/2, Single-Blinded Trial to Evaluate the Safety and Efficacy of Intra-Articular (IA) Injection of XytriX in Adult Subjects With Grade I-IV Knee Osteoarthritis (KOA)
TricelX Inc.
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for enrollment: Adult patient aged 18 years or older with Grade I-IV knee osteoarthritis as determined by radiographic (X-ray) evaluation. Ambulatory subject with symptoms of knee osteoarthritis for at least 3 months, who may be receiving conservative therapy (e.g., oral anti-inflammatory medication) and/or physical therapy. In subjects with bilateral knee OA, the more symptomatic knee will be designated as the target knee. Subject with joint pain equal to or greater than 7 (out of a total pain score of 24…
Interventions
- BiologicalMesenchymal Stem Cell Injection
Subjects will receive an intra-articular injection of mesenchymal stem cells derived from umbilical cord tissue
Location
- TriCelXFrisco, Texas