This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 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
104
Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
Soonchunhyang University Hospital
Bucheon-si, Gyeonggi-do, South Korea
RECRUITINGBucheon ST. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGEvaluation of systemic tolerance through incidence of abnormal laboratory test results
Time frame: Up to 9 months
Evaluation of incidence of clinically significant change in physical examination and vital signs
Time frame: Up to 18 months
Evaluation of localized tolerance through incidence of clinically significant change about treatment area
Time frame: Up to 24 months
Evaluation of incidence of adverse events
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Borame Medical Center
Seoul, South Korea
RECRUITING