This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.
ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a Dystrophic Epidermolysis Bullosa.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Dressing for Dystrophic Epidermolysis Bullosa wound.
Dressing for Dystrophic Epidermolysis Bullosa wound.
Gangnam Severence Hospital
Seoul, South Korea
Area of re-epithelization
Time frame: Follow up to 8 weeks
Percentage of a target wound's re-epithelialization
Time frame: Every time of visit for follow up to 8 weeks
Time taken to re-epithelization
Time frame: Over 8 weeks
Safety assessed by clinically measured abnormality of laboratory tests and adverse events
Time frame: Over 8 weeks
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