Dystrophic Epidermolysis Bullosa
Conditions
Keywords
Epidermolysis Bullosa, Stem cell
Brief summary
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months.
Detailed description
This is an open-label follow up study to evaluate the efficacy and safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial (ALLO-ASC-EB-101) 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 Dystrophic Epidermolysis Bullosa.
Interventions
BIOLOGICALALLO-ASC-DFU
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 Dystrophic Epidermolysis Bullosa. This study is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells
Sponsors
Anterogen Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by clinically measured abnormality of laboratory tests and adverse events | Every time of visit for follow up to 24 months | Number of Participants with Adverse Events as a Measure of Safety and Tolerability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area of re-epithelization | Every time of visit for follow up to 24 months | Time taken to re-epithelization |
Countries
South Korea
Outcome results
None listed