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)

NCT07487766 Phase 1/Phase 2 NOT_YET_RECRUITING

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.

Details

Lead sponsor	TricelX Inc.
Phase	Phase 1/Phase 2
Status	NOT_YET_RECRUITING
Enrolment	75
Start date	2026-05
Completion	2028-12

Conditions

• Osteoarthritis

Interventions

• Mesenchymal Stem Cell Injection

Primary outcomes

• Knee Injury and Osteoarthritis Outcome Score — 24 months
  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 — 24 months
  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.

Countries

United States