Diabetic Foot Ulcer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALALLO-ASC-DFU
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer. This study is a follow-up study without intervention.
OTHERStandard therapy
Standard therapy conducted for patients with diabetic foot ulcer. This study is a follow-up study without intervention.
Sponsors
Anterogen Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | up to 24 months | Evaluation of AE |
Countries
South Korea
Outcome results
None listed