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A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT05549609•Xintela AB

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent for participation in the study
•Male or female patient aged ≥18 years
•BMI ≥18.5 and ≥40.0 kg/m2
•Lower leg wound due to venous insufficiency
•Target wound has failed to heal despite standard wound care for a minimum of 6 weeks
•A surface area of the target wound of ≥2 and ≤40 cm2

Exclusion Criteria

•Signs or symptoms of clinically significant ongoing infection i the target wound requiring anti-microbial treatment
•History of autoimmune disease, such as but not limited to systemic lupus erythematosus, Addison's disease, Crohn's disease and type I diabetes mellitus
•B-HbA1C value ≥52 mmol/mol
•Plaque psoriasis or any other skin disease that could interfere with the outcome of the study
•Arterial insufficiency
•History of any malignancy within the past 5 years
•Target wound diagnosed as a malignant wound, neuropathic wound, pressure wound or osteomyelitis
•Patients who are immunocompromised due to disease or for other reasons such as the use of systemic immunosuppressants

Locations (4)

Clinical Trial Center (CTC)

Gothenburg, Sweden

Burn Centre, Linköping University Hospital

Linköping, Sweden

Clinical Research Unit

Lund, Sweden

Clinical Trial Consultants (CTC) Karolinska

Stockholm, Sweden

Key Dates

Start Date

October 26, 2022

Primary Completion Date

October 1, 2025

Completion Date

October 1, 2025

Last Updated

May 4, 2025

Enrollment

ESTIMATED participants

Conditions

Venous Leg Ulcer

Interventions

XSTEM-VLU

BIOLOGICAL

Vehicle

OTHER

Contacts

Central contact

CONTACT

+46 73 435 53 42 clinicaltrials@xintela.se

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone

Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population

Finnish Venous Ulcer Study (FINNULCER Study)

A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.