drugset / Trial / NCT05157958

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

NCT05157958 ↗

Phase 2 Unknown 6 enrolled Anterogen Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-05-01
Primary completion
2025-10-01
Completion
2026-04-28

Drugs

EvaluationDrugModalityDoseRoute
Subject ALLO-ASC-SHEET Cell therapy — —