drugset
drugset / Trial / NCT05344157

A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis

NCT05344157 ↗

Phase 1/2 Completed 24 enrolled Xindu Pty Ltd Xintela AB · collab
NaSingle-groupOpen-labelTreatment

Summary

The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-OA when administered as a single intra-articular injection to patients with symptomatic knee osteoarthritis. The study is divided into two parts; a dose escalation (Part A) and an optional dose expansion part (Part: B). Three dose levels are planned to be evaluated in Part A and selected dose level(s) may be further expanded in Part B.

Timeline

Start
2022-06-22
Primary completion
2025-06-18
Completion
2025-06-18

Drugs

EvaluationDrugModalityDoseRoute
Subject XSTEM-OA Cell therapy — Other

Indications

osteoarthritis, knee