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

Venous Leg Ulcer Clinical Trial

Official title:
A Multi-centre, Randomised, Single-blind Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of a Single Topical Dose of Allogeneic Integrin α10β1-selected Mesenchymal Stem Cells (XSTEM-VLU) in Patients With Difficult-to-heal Venous Leg Ulcers

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05549609
Study type Interventional
Source Xintela AB
Contact Central contact
Phone +46 73 435 53 42
Email clinicaltrials@xintela.se
Status Recruiting
Phase Phase 1/Phase 2
Start date October 26, 2022
Completion date June 2024
View Details
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