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After confirming eligibility, a single subject with four selected target lesions will receive both ALLO-ASC-SHEET and Vehicle control, three target lesions for ALLO-ASC-SHEET and the other target for Vehicle control, and which lesion to apply which IP treatment will be determined randomly at the time of enrollment using pre-designed block randomization scheme.
Primary efficacy endpoint will be assessed during and after 12th IP applications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLO-ASC-SHEET | Experimental | Allogeneic mesenchymal stem cells Dressing for Dystrophic Epidermolysis Bullosa wound |
|
| Conventional Therapy | Active Comparator | Hydrogel Sheet Matching control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-ASC-SHEET | Biological | Weekly administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Incidence, severity, relationship of adverse event | First application to week 37 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of complete wound closure | Proportion of subject with target skin ulcer area meeting the definition of wound closure during and at the completion of 12 weeks treatment | First application to week 17 |
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Key Inclusion Criteria:
Subject diagnosed as dystrophic epidermolysis bullosa confirmed by clinical criteria and one of the following:
Subject with skin ulcer lesions of dystrophic epidermolysis bullosa meet the following criteria, on the screening start day (Visit 1) and treatment start day (enrollment day) (Visit 3):
Subject who has two comparable target skin ulcer lesions, and each lesions with a change of size equal to or less than ±50% at treatment day (Visit 3) compared to that of screening day (Visit 1)
Subject who has no clinical evidence of infection related signs/symptoms, or visible necrosis in the target skin ulcer area (area including ulcer lesion and surrounding area where the IP is to be applied).
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernanda Bellodi Schmidt | Contact | 82-2-2014-0391 | antstudy@anterogen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Dermatology Clinical Trials Unit | Recruiting | Miami | Florida | 33125 | United States |
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| ID | Term |
|---|---|
| D016108 | Epidermolysis Bullosa Dystrophica |
| ID | Term |
|---|---|
| D004820 | Epidermolysis Bullosa |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Vehicle Control |
| Other |
Weekly administration |
|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D012872 | Skin Diseases, Vesiculobullous |