A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-201 Clinical Trial

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.

• ALLO-ASC-DFU (Biological), also known as Allogeneic mesenchymal stem cells: Application of ALLO-ASC-DFU sheet to diabetic foot ulcer. This study is a follow-up study without intervention.
• Standard therapy (Other): Standard therapy conducted for patients with diabetic foot ulcer. This study is a follow-up study without intervention.

Primary outcomes

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability [up to 24 months]: Evaluation of AE

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-DFU-201.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1\. Subjects who are considered not suitable for the study by the principal investigator.

• Seung-Kyu Han, MD. Ph D., Principal investigator, Korea University Guro Hospital
• Ki-Won Young, MD. Ph D., Principal investigator, Eulji General Hospital
• Hyun-suk Suh, MD. Ph D., Principal investigator, Asan Medical Center
• Jin Woo Lee, MD. Ph D., Principal investigator, Severance Hospital