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

June 23, 2026 updated by: Xintela AB

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Gothenburg, Sweden, SE-413 46
        • Clinical Trial Center (CTC)
      • Stockholm, Sweden, SE-171 64
        • Clinical Trial Consultants (CTC) Karolinska

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Major 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

Major 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: XSTEM-VLU
Single topical dose of XSTEM-VLU
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.
Placebo Comparator: Vehicle
Single topical dose of CryoStor CS10
Other: Vehicle
CryoStor CS10 cryomedium

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability: Adverse events (AEs)
Time Frame: From study start to 4 months after dosing
Frequency, seriousness and intensity of AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
From study start to 4 months after dosing
Safety and tolerability: Local tolerability
Time Frame: From study start to 4 months after dosing
Local tolerability evaluated by direct inspection by need for debridement (Yes/No) and clinical signs of wound infection (Yes/No)
From study start to 4 months after dosing
Safety and tolerability: Number of participants with abnormal 12-lead electrocardiogram (ECG)
Time Frame: From study start to 4 months after dosing
Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
From study start to 4 months after dosing
Safety and tolerability: Number of participants with abnormal vital signs
Time Frame: From study start to 4 months after dosing
Vital signs include blood pressure, pulse and body temperature. Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
From study start to 4 months after dosing
Safety and tolerability: Number of participants with abnormal laboratory test results
Time Frame: From study start to 4 months after dosing
Laboratory tests include clinical chemistry, haematology and coagulation parameters. Abnormal values assessed by the Investigator as clinically significant will be reported as AEs.
From study start to 4 months after dosing
Safety and tolerability: Number of participants with abnormal physical examination findings
Time Frame: From study start to 4 months after dosing
Abnormal findings assessed by the Investigator as clinically significant will be reported as AEs.
From study start to 4 months after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preliminary efficacy: Wound area reduction (absolute and percentage) compared to baseline
Time Frame: From study start to 4 months after dosing
From study start to 4 months after dosing
Preliminary efficacy: Proportion of patients with re-epithelialization of >=95% and >=50% of the wound area measured at baseline
Time Frame: From study start to 4 months after dosing
From study start to 4 months after dosing
Preliminary efficacy: Time to re-epithelialization of >=95% and >=50% of the wound area measured at baseline
Time Frame: From study start to 4 months after dosing
From study start to 4 months after dosing
Preliminary efficacy: Pain for target wound and the affected leg using Visual Analogue Scale (VAS)
Time Frame: From study start to 4 months after dosing
The VAS consists of a 100 mm line from no pain (0 mm) to worst possible pain (100 mm).
From study start to 4 months after dosing
Preliminary efficacy: Scar formation assessed by the Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: At week 10 and at 4 months after dosing
The POSAS is divided into two scales (for patient and for observer), each with six items scored numerically (1 -10). The lowest score "1" corresponds to normal skin.
At week 10 and at 4 months after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xintela AB

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vinnova

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Folke Sjöberg, Burn Centre, Linkoping University Hospital, Linkoping, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XIN-XSTEM-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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