Loading clinical trials...

Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

Double Blind, Randomized, Phase II Clinical Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET Versus Vehicle Control in Dystrophic Epidermolysis Bullosa (DEB) Patients

NCT05157958•Anterogen Co., Ltd.

View on ClinicalTrials.gov

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.

Detailed Description

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

Eligibility

Age

4 - 60 years

Sex

ALL

Healthy Volunteers

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).

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.

Locations (1)

University of Miami Dermatology Clinical Trials Unit

Miami, Florida, United States

Key Dates

Start Date

May 1, 2023

Primary Completion Date

October 1, 2025

Completion Date

April 28, 2026

Last Updated

April 22, 2024

Enrollment

ESTIMATED participants

Conditions

Dystrophic Epidermolysis Bullosa

Interventions

ALLO-ASC-SHEET

BIOLOGICAL

Vehicle Control

OTHER

Contacts

Fernanda Bellodi Schmidt

CONTACT

82-2-2014-0391 antstudy@anterogen.com

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

NCT04213261

Recessive Dystrophic Epidermolysis Bullosa

View study

ACTIVE_NOT_RECRUITINGPHASE3

Evaluation of D-Fi for the Treatment of Wounds Due to DEB

NCT06892639

Dystrophic Epidermolysis Bullosa

View study

ACTIVE_NOT_RECRUITINGPHASE1

Pilot Study of ELK-003 Eye Drops for Treating Ocular Manifestations of Epidermolysis Bullosa

NCT06713434

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

Evaluation of D-Fi for the Treatment of Wounds Due to DEB

Pilot Study of ELK-003 Eye Drops for Treating Ocular Manifestations of Epidermolysis Bullosa

A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients

Targeting Collagen VII Antibodies in Bullous Diseases Using Efgartigimod IV (VYVGART)

Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa