NCT05549609

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Xintela AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	XSTEM-VLU	XSTEM-VLU is an allogeneic, adipose tissue-derived, integrin alpha10beta1-selected and expanded mesenchymal stem cell (MSC) product for the treatment of venous leg ulcers.
OTHER	Vehicle	CryoStor CS10 cryomedium

Timeline

• Start date: 2022-10-26
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2022-09-22
• Last updated: 2025-05-04

Locations

4 sites across 1 country: Sweden