Last updated: April 19, 2024
Sponsor: Anterogen Co., Ltd.
Overall Status: Active - Recruiting
Phase
2
Condition
Epidermolysis Bullosa
Treatment
Vehicle Control
ALLO-ASC-SHEET
Clinical Study ID
NCT05157958
ALLO-ASC-DEB-201
Ages 4-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Subject diagnosed as dystrophic epidermolysis bullosa confirmed by clinical criteriaand one of the following:
- Immunostaining test: patients who have reduced or no type 7 collagen in stainingdegree of immunofluorescence. Other antigens (laminin-332, type 17 collagen,plectin, integrin α6β4, type 5 and type 14 keratin, etc.) are normal inimmune-staining.
- COL7A1 mutational analysis: confirmation of COL7A1 genetic mutation.
- Subject with skin ulcer lesions of dystrophic epidermolysis bullosa meet the followingcriteria, on the screening start day (Visit 1) and treatment start day (enrollmentday) (Visit 3):
- Subject has two skin ulcer lesions judged as comparable to compare the safety andefficacy 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 achange of size equal to or less than ±50% at treatment day (Visit 3) compared to thatof screening day (Visit 1)
- Subject who has no clinical evidence of infection related signs/symptoms, or visiblenecrosis in the target skin ulcer area (area including ulcer lesion and surroundingarea where the IP is to be applied).
Exclusion
Key Exclusion Criteria:
- Subject who requires antibiotics due to bacterial infection on skin of the target skinulcer area (area including ulcer lesion and surrounding area where the IP is to beapplied).
- Female subjects: pregnant woman (indicated by serum hCG test result at screening),breast-feeding patient, all sexually active patient, with child bearing potential incase of female*, who is not willing to contracept** during the clinical trial.
Study Design
Total Participants: 6
Treatment Group(s): 2
Primary Treatment: Vehicle Control
Phase: 2
Study Start date:
May 01, 2023
Estimated Completion Date:
April 28, 2026
Study Description
Connect with a study center
University of Miami Dermatology Clinical Trials Unit
Miami, Florida 33125
United StatesActive - Recruiting
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