drugset / Trial / NCT05549609

A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers

NCT05549609 ↗

Phase 1/2 Completed 6 enrolled Xintela AB Vinnova · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers. The study is randomised and the patients will receive either XSTEM-VLU or vehicle as add on to standard wound care. The patients will be followed weekly for 10 weeks after treatment. At 4 months after treatment, the patients will return to the clinic for an end-of-study visit.

Timeline

Start
2022-10-26
Primary completion
2026-02-11
Completion
2026-02-11

Drugs

EvaluationDrugModalityDoseRoute
Subject XSTEM-VLU Cell therapy — Topical

Indications