Overview
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.
Description
Primary efficacy endpoint will be assessed during and after 12th IP applications.
Eligibility
Key Inclusion Criteria:
- Subject diagnosed as dystrophic epidermolysis bullosa confirmed by clinical criteria
and one of the following:
- Immunostaining test: patients who have reduced or no type 7 collagen in staining degree of immunofluorescence. Other antigens (laminin-332, type 17 collagen, plectin, integrin α6β4, type 5 and type 14 keratin, etc.) are normal in immune-staining.
- COL7A1 mutational analysis: confirmation of COL7A1 genetic mutation.
- 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 has two skin ulcer lesions judged as comparable to compare the safety and efficacy by investigator during screening period and prior to the IP application (enrollment day).
- Two skin ulcer lesions meeting criteria stated in 2a) should be sized 5-20 cm2 (inclusive)
- 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:
- Subject who requires antibiotics due to bacterial infection on skin of the target skin ulcer area (area including ulcer lesion and surrounding area where the IP is to be applied).
- Female subjects: pregnant woman (indicated by serum hCG test result at screening), breast-feeding patient, all sexually active patient, with child bearing potential in case of female, who is not willing to contracept* during the clinical trial.