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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 Dystrophic Epidermolysis Bullosa. This study is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by clinically measured abnormality of laboratory tests and adverse events | Number of Participants with Adverse Events as a Measure of Safety and Tolerability. | Every time of visit for follow up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area of re-epithelization | Time taken to re-epithelization | Every time of visit for follow up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
1. Subjects who are considered not suitable for the study by the principal investigator.
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Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101
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| Name | Affiliation | Role |
|---|---|---|
| Su Chan Kim, PhD | Gangnam Severence Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severence Hospital | Seoul | 135-720 | South Korea |
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| ID | Term |
|---|---|
| D016108 | Epidermolysis Bullosa Dystrophica |
| D004820 | Epidermolysis Bullosa |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
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| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D012872 | Skin Diseases, Vesiculobullous |