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Stem cell shot aims to heal stubborn leg wounds

NCT ID NCT05549609

Disease control Sponsor: Xintela AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tested a single topical dose of stem cells (XSTEM-VLU) in 6 people with difficult-to-heal venous leg ulcers. The goal was to check safety and see if the treatment helps wounds close faster when added to standard care. Participants were followed for 10 weeks after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
stem cells (XSTEM-VLU)
What this could lead to
If it works, this could point toward a new treatment that helps heal stubborn leg ulcers faster.
What could go wrong
This is a very early, tiny trial (6 people) testing safety first. It may not show clear benefit, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

6 people

The number who actually took part.

Started

Oct 2022

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Venous leg ulcer

Contacts and locations

Locations

  • Clinical Trial Center (CTC)

    Gothenburg, SE-413 46, Sweden

  • Clinical Trial Consultants (CTC) Karolinska

    Stockholm, SE-171 64, Sweden

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