A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-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-BI-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 burn.

• ALLO-ASC-DFU (Biological): 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 burn. This tudy is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells

Primary outcomes

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

Secondary outcomes

• Vancouver Burn Scar Scale [Every time of visit for follow up to 24 weeks]: Evaluation of Vancouver Burn Scar Scale

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-BI-201.
2. A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided.

Exclusion Criteria:

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

• Wook Chun, PhD, Principal investigator, Hallym University Medical Center