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This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.
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 an new option in treating a Dystrophic Epidermolysis Bullosa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLO-ASC-DFU | Experimental |
| |
| Conventional Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic mesenchymal stem cells | Other | Dressing for Dystrophic Epidermolysis Bullosa wound. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area of re-epithelization | Follow up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of a target wound's re-epithelialization | Every time of visit for follow up to 8 weeks | |
| Time taken to re-epithelization | Over 8 weeks | |
| Safety assessed by clinically measured abnormality of laboratory tests and adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Polyurethene Film | Device | Dressing for Dystrophic Epidermolysis Bullosa wound. |
|
| Over 8 weeks |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D012872 | Skin Diseases, Vesiculobullous |