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

Dystrophic Epidermolysis Bullosa Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

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

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05157958
Study type Interventional
Source Anterogen Co., Ltd.
Contact Fernanda Bellodi Schmidt
Phone 82-2-2014-0391
Email antstudy@anterogen.com
Status Recruiting
Phase Phase 2
Start date May 1, 2023
Completion date April 28, 2026
View Details
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