Trial intelligence / Profile preview

XytriX in Adult Subjects With Grade I-IV Knee Osteoarthritis

NCT07487766Phase 2

Key facts

Status: Not yet recruiting
Start: May 2026
Primary completion: May 2027
Countries: 1
Sponsor: TricelX
Modality: Stem Cell Therapies

Drugs: XytriX
Conditions: knee osteoarthritis (OA)

Overview

Phase 2, randomised, single-blind trial of XytriX in knee osteoarthritis (OA) (3 arms), sponsored by TricelX. Primary endpoints: Knee Injury and Osteoarthritis Outcome Score at 24 months and Western Ontario and McMaster Universities Osteoarthritis Index at 24 months. Planned start May 2026; status: not yet recruiting.

Design

3 arms

Study design: RandomizedSingle-blind

XytriX 10M
10 million cells IA injection
XytriX 30M
30 million cells IA injection
XytriX 50M
50 million cells IA injection

Who it enrols

Adults with Grade I-IV knee osteoarthritis, BMI <= 40, experiencing symptoms for at least 3 months with significant joint pain, excluding those with recent knee surgeries, injections, or systemic autoimmune/infectious diseases.

Endpoints

Primary

Knee Injury and Osteoarthritis Outcome Score24 months
Western Ontario and McMaster Universities Osteoarthritis Index24 months

Secondary

Visual Analog Pain Score24 months
Knee Injury and Osteoarthritis Outcome Score Sub-Scale24 months
Short Form-3624 months
Timed Up and Go Test24 months

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