Scar remodeling after burn injury using stem cells from fat tissue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ScarASC program combines Phase 1 and Phase 2 to test safety and preliminary effectiveness of allogeneic adipose-derived mesenchymal stromal cells for burn scar remodeling. In the randomized design, two 6 cm by 6 cm scar areas on each patient receive either the stem cell treatment or placebo, with patient-reported outcomes as the primary endpoint and objective 3D scar assessments as complementary data. Participants are adults with mature hypertrophic burn scars on the front torso or extremities, without significant comorbidities. The study uses cryopreserved adipose-derived cells delivered in Cryostor CS10 with Ringers lactate. Trial locations include Copenhagen and collaborating Danish centers, led by Rigshospitalet with university partners.

Why it matters

Who can join: the full rules

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.

Where it's running

• Copenhagen University Hospital
  Copenhagen, East, Denmark Recruiting

Study contacts

• Study coordinator: Laura Hansen, MD
• Email: laura.hansen.01@regionh.dk
• Phone: +45 25330409

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.