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Набира участници Фаза 2 2024-519160-41-00

Scar Remodeling after Burn Injury using Adipose-derived Allogeneic Stem Cells (ScarASC)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Hypertrophic scarring.

Спонсор: Copenhagen University Hospital

Налично на: БГ
Обобщение
Trial status: Authorised Change in total observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0., Scar volume and microstructure measured by three-dimensional photography, measured in nano cubic meter., Scar elevation index / scar thickness by ultrasound video sequencing, measured as a ratio and in milli meter., Changes in collagen fiber arrangement., Up- and/or downregulation of biomarkers from punch biopsies., Development of de novo HLA., Histologic assessment of the presence of donor stem cells / DNA., Safety assessment by documenting any adverse events or suspected unexpected serious adverse reactions at every follow-up. Change in total patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0.
Описание
Change in total observer score of the Danish Patient and Observer Scar Assessment Scale version 3.0., Scar volume and microstructure measured by three-dimensional photography, measured in nano cubic meter., Scar elevation index / scar thickness by ultrasound video sequencing, measured as a ratio and in milli meter., Changes in collagen fiber arrangement., Up- and/or downregulation of biomarkers from punch biopsies., Development of de novo HLA., Histologic assessment of the presence of donor stem cells / DNA., Safety assessment by documenting any adverse events or suspected unexpected serious adverse reactions at every follow-up.
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 39 participants
Интервенции
CryoStor CS10 + Physiologic solution, e.g., Ringers Lactate
Drug
Culture expanded Adipose Derived Regenerative Cells, ADRC001
Drug
Места на провеждане 1
Дания (1)
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
11.04.2025
Регистрационен номер
2024-519160-41-00
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

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