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

Обзор

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.

Вмешательства

• Препарат Allogeneic adipose-Derived Mesenchymal Stromal Cells
  Advanced therapeutic medicinal product
• Другое Cryostor CS10 + Ringers Lactate
  Placebo

Первичные конечные точки

• Change in Patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0 [Срок оценки: From enrollment to 12-month follow-up.]

Вторичные конечные точки (8)

• Change in Observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0 [Срок оценки: From enrollment to 12-month follow-up.]
• Documentation of any adverse events (AEs), serious adverse advents (SAEs), and deaths. [Срок оценки: From the day of intervention to 12-month follow-up.]
• Changes in scar volume and microstructure in nanocubic meters. [Срок оценки: From enrollment to 12-month follow-up.]
• Changes in scar elevation index/scar thickness as a ratio and in millimeters. [Срок оценки: From enrollment to 12-month follow-up.]
• Changes in collagen fiber arrangement. [Срок оценки: From baseline biopsies to 12-month biopsies.]
• Up- or downregulation of fibrotic, inflammatory, and matrix remodeling biomarkers. [Срок оценки: From baseline biopsies to 12-month biopsies.]
• The presence of donor stem cells/DNA [Срок оценки: From punch biopsies at 12 months post-intervention.]
• Immune response/presence of donor-specific antibodies. [Срок оценки: From baseline blood samples to six- and 12-month follow-up blood samples.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Copenhagen University Hospital — Copenhagen

Идентификаторы

NCT: NCT07635875 · ScarASC · 2024-519160-41-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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