This is a phase I open-label study to evaluate the safety of ALLO-ASC-DFU in diabetic foot ulcers patients. 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 diabetic foot ulcer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Asan Medical Center
Seoul, South Korea
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: up to 4 weeks
Wound size and depth measurement
Evaluation of the improvement of wound measured by size and depth, and examines the change for 4 weeks period.
Time frame: baseline and 1, 2, 4 weeks
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