Scar Remodeling After Burn Injury Using Allogeneic Adipose-derived Stromal Cells (ScarASC)
3. juni 2026 oppdatert av: Rikke Holmgaard, Rigshospitalet, Denmark
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
39
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Laura Hansen, MD
- Telefonnummer: +45 25330409
- E-post: laura.hansen.01@regionh.dk
Studiesteder
-
-
East
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Copenhagen, East, Danmark, 2100
- Rekruttering
- Copenhagen University Hospital
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Ta kontakt med:
- Laura Hansen, MD
- Telefonnummer: +45 25330409
- E-post: laura.hansen.01@regionh.dk
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: All participants
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.
|
Advanced therapeutic medicinal product
Placebo
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0
Tidsramme: From enrollment to 12-month follow-up.
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The total score from all items, excluding the overall satisfaction
|
From enrollment to 12-month follow-up.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0
Tidsramme: From enrollment to 12-month follow-up.
|
The total score from all items, excluding the overall satisfaction
|
From enrollment to 12-month follow-up.
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Documentation of any adverse events (AEs), serious adverse advents (SAEs), and deaths.
Tidsramme: From the day of intervention to 12-month follow-up.
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All events will be documented and evaluated.
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From the day of intervention to 12-month follow-up.
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Changes in scar volume and microstructure in nanocubic meters.
Tidsramme: From enrollment to 12-month follow-up.
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Measured by three-dimensional photography and software.
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From enrollment to 12-month follow-up.
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Changes in scar elevation index/scar thickness as a ratio and in millimeters.
Tidsramme: From enrollment to 12-month follow-up.
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Measured by ultrasound video sequencing.
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From enrollment to 12-month follow-up.
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Changes in collagen fiber arrangement.
Tidsramme: From baseline biopsies to 12-month biopsies.
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Descriptive assessment of punch biopsies.
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From baseline biopsies to 12-month biopsies.
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Up- or downregulation of fibrotic, inflammatory, and matrix remodeling biomarkers.
Tidsramme: From baseline biopsies to 12-month biopsies.
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Advanced Nanostring technology.
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From baseline biopsies to 12-month biopsies.
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The presence of donor stem cells/DNA
Tidsramme: From punch biopsies at 12 months post-intervention.
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Descriptive assessment of punch biopsies.
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From punch biopsies at 12 months post-intervention.
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Immune response/presence of donor-specific antibodies.
Tidsramme: From baseline blood samples to six- and 12-month follow-up blood samples.
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Evaluated by the development of de novo HLA.
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From baseline blood samples to six- and 12-month follow-up blood samples.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. april 2026
Primær fullføring (Antatt)
1. april 2028
Studiet fullført (Antatt)
31. mai 2028
Datoer for studieregistrering
Først innsendt
3. juni 2026
Først innsendt som oppfylte QC-kriteriene
3. juni 2026
Først lagt ut (Faktiske)
9. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ScarASC
- 2024-519160-41-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
All IPD that underlies results in a publication will be shared.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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