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

NCT05549609 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-05-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Vinnova

    collaborator OTHER_GOV

  • Xintela AB

    lead INDUSTRY

Principal Investigators

  • Folke Sjöberg · Burn Centre, Linkoping University Hospital, Linkoping, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05549609 on ClinicalTrials.gov