Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa

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

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Subject diagnosed as dystrophic epidermolysis bullosa confirmed by clinical criteriaand one of the following:
  2. 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.
  3. COL7A1 mutational analysis: confirmation of COL7A1 genetic mutation.
  4. 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):
  5. 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).
  6. Two skin ulcer lesions meeting criteria stated in 2a) should be sized 5-20 cm2 (inclusive)
  7. 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)
  8. 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:

  1. 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).
  2. 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

Primary efficacy endpoint will be assessed during and after 12th IP applications.

Connect with a study center

  • University of Miami Dermatology Clinical Trials Unit

    Miami, Florida 33125
    United States

    Active - Recruiting

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