Scar Remodeling After Burn Injury Using Allogeneic Adipose-derived Stromal Cells

NCT07635875 | Recruiting Phase 1

• 2 other identifiers: ScarASC2024-519160-41-00
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The present project serves to test whether stem cell therapy offers a new treatment option for the scars of burn survivors. In Denmark, 12.000 people seek medical assistance every year for burn injuries leaving thousands of people with the devastating condition of hypertrophic scarring. Affected patients experience pain, itching, numbness, and reduced range of motion, which profoundly impact their quality of life. We hypothesize that adipose-derived stem cells can improve scar quality. To test this, we have conducted an integrated phase I + II trial (the ScarASC trials). ScarASC will be the first randomized controlled trial to use stem cells in burn patients. Two scar areas in each patient will be randomly injected with A) allogeneic adipose-derived stem cells and B) the control medium (placebo). We maintain a patient-centered scope, with our primary endpoint being a patient-reported outcome measure. However, we also obtain objective scar assessments using three-dimensional photographs, the scar elevation index, and gene/protein expression regulation.

Conditions

Scar Quality Assessment and Safety; Scar Tissue; Scar Conditions and Fibrosis of Skin

Keywords

Mesenchymal stromal cell therapy; Cell therapy; Regenerative medicine; Scar tissue; Clinical trial; ATMP

Outcome Measures

Primary Outcomes (1)

• Change in Patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0

  The total score from all items, excluding the overall satisfaction

  From enrollment to 12-month follow-up.

Secondary Outcomes (8)

• Change in Observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0

  From enrollment to 12-month follow-up.

• Documentation of any adverse events (AEs), serious adverse advents (SAEs), and deaths.

  From the day of intervention to 12-month follow-up.

• Changes in scar volume and microstructure in nanocubic meters.

  From enrollment to 12-month follow-up.

• Changes in scar elevation index/scar thickness as a ratio and in millimeters.

  From enrollment to 12-month follow-up.

• Changes in collagen fiber arrangement.

  From baseline biopsies to 12-month biopsies.

Study Arms (1)

All participants

OTHER

All participants will receive both interventions (stromal cells (IMP) and placebo) in two separate scar areas. The treatments are masked and randomly allocated to the two scar areas.

Drug: Allogeneic adipose-Derived Mesenchymal Stromal Cells; Other: Cryostor CS10 + Ringers Lactate

Interventions

Cryostor CS10 + Ringers Lactate OTHER

Placebo

All participants

Allogeneic adipose-Derived Mesenchymal Stromal Cells DRUG

Advanced therapeutic medicinal product

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Odense University Hospital: collaborator
• University of Southern Denmark: collaborator
• Københavns Universitet: collaborator

Study Sites (1)

Copenhagen University Hospital

Copenhagen, East, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Cicatrix

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Laura Hansen, MD

CONTACT

+45 25330409; laura.hansen.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Participants, care providers, investigators, and outcome assessors are all masked. All participants receive both treatments (IMP and placebo). However, the above-mentioned parties are blinded to which scar area will receive what treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor and Associate Professor

Model Details: Within-participant randomized, triple-blinded study in which each participant receives both treatments (IMP and placebo) administered to two separate scar areas.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)