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Recruiting Phase 2 2024-519160-41-00

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

Phase 2 – studying effectiveness and dosage
Conditions: Hypertrophic scarring.

Sponsor: Copenhagen University Hospital

trial.available_in: БГ
Overview
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.
Description
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.
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 39 participants
Interventions
CryoStor CS10 + Physiologic solution, e.g., Ringers Lactate
Drug
Culture expanded Adipose Derived Regenerative Cells, ADRC001
Drug
Locations 1
Denmark (1)
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
11.04.2025
Registry ID
2024-519160-41-00
Source
euclinicaltrials.eu
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