This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months. 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 a Diabetic Foot Ulcer.
Study Type
OBSERVATIONAL
Enrollment
54
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer. This study is a follow-up study without intervention.
Standard therapy conducted for patients with diabetic foot ulcer. This study is a follow-up study without intervention.
Eulji General Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Asan medical center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Evaluation of AE
Time frame: up to 24 months
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