This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn wound subjects.
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 a new option in treating Deep Second-degree burn wounds.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Dressing for Second Deep degree Burn injury
Typical therapy conducted for burn injury patients
Hallym university Medical Center
Seoul, South Korea
Time of re-epithelialization
Time of re-epithelialization
Time frame: Follow up to 12 weeks
Safety (laboratory tests and adverse events)
Clinically measured abnormality of laboratory tests and adverse events
Time frame: Follow up to 12 weeks
Burn Scar Index
Vancouver Burn Scar Scale
Time frame: Follow up to 12 weeks
healing status of the wound evidenced by photography
healing status of the wound evidenced by photography
Time frame: follow up to 12 weeks
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