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Can stem cells heal burn scars? new trial aims to find out

NCT ID NCT07635875

Disease control Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether injections of stem cells from donated fat tissue can improve the quality of old burn scars. 39 adults with hypertrophic scars (at least 2 years old) will receive stem cells in one scar area and a placebo in another. The main goal is to see if patients report less pain, itching, and tightness, and if scars look and feel better.

What this could mean

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

Active substance
allogeneic adipose-derived mesenchymal stromal cells (stem cells from donated fat tissue)
What this could lead to
If it works, this could offer a new treatment to reduce pain, itching, and stiffness from burn scars, improving quality of life for survivors.
What could go wrong
This is an early phase 1/2 trial with only 39 people, so results may not apply to everyone. Stem cell treatments can have side effects like injection site reactions or unexpected immune responses.

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

About 39 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Accepted

You do not need to have the condition being studied to take part.

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.

Inclusion Criteria: * Adults ≥ 18 years of age * Males and females * Hypertrophic scars (age of scar \> 2 years) after burn injuries on the front thorax or extremities. * Two uniform 6 cm x 6 cm areas of burn scar tissue on the front thorax or extremities. The scar should be large enough to separate the areas by a minimum of two centimeters. * Ability to understand information about the project. Exclusion Criteria: * Significant comorbidities or lack of cognitive abilities to follow instructions. * Not being able to participate due to language or other personal issues. * Pregnancy or breastfeeding * Current or previous steroid therapy (systemic or local) within one year. * Scar revision surgery within one year in the affected areas. * Keloids. * Active cancer or previous cancer within two years (skin cancers do not apply) * Penicillin and Streptomycin allergy.

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Conditions

The condition(s) this trial relates to.

severe cutaneous adverse reaction

As listed by the trial registrant

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

Scar conditions and fibrosis of skin Scar quality assessment and safety Scar tissue

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Copenhagen University Hospital

    RECRUITING

    Copenhagen, East, 2100, Denmark

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