Recruiting
Phase 2

ALLO-ASC-SHEET

Sponsor:

Anterogen Co., Ltd.

Code:

NCT05157958

Conditions

Dystrophic Epidermolysis Bullosa

Eligibility Criteria

Sex: All

Age: 4 - 60

Healthy Volunteers: Not accepted

Interventions

ALLO-ASC-SHEET

Vehicle Control

Study Details

Brief 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.

Conditions

Dystrophic Epidermolysis Bullosa

Study ID

NCT05157958

Start date

May 1, 2023

Status verified date

Apr, 2024

Completion date

Apr 28, 2026

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 60

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Subject diagnosed as dystrophic epidermolysis bullosa confirmed by clinical criteria and one of the following:

1. 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.
2. COL7A1 mutational analysis: confirmation of COL7A1 genetic mutation.
2. 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):

1. 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).
2. Two skin ulcer lesions meeting criteria stated in 2a) should be sized 5-20 cm2 (inclusive)
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)
4. 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:

1. 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).
2. 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.

Study Design

Enrollment

6 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALLO-ASC-SHEET

Allogeneic mesenchymal stem cells

Dressing for Dystrophic Epidermolysis Bullosa wound

active comparator: Conventional Therapy

Hydrogel Sheet

Matching control

Interventions

ALLO-ASC-SHEET

Weekly administration

Vehicle Control

Weekly administration

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: First application to week 37 ]

Central Contacts and Locations

Central contacts

Locations

University of Miami Dermatology Clinical Trials Unit

Recruiting

Miami, Florida, United States, 33125

More Information

Sponsor

Anterogen Co., Ltd.

Last update posted

Apr 22, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Anterogen Co., Ltd. on 2024-04-22.