NCT05157958

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Anterogen Co., Ltd. · Industry
• Sex: All
• Age: 4 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dystrophic Epidermolysis Bullosa

Interventions

Type	Name	Description
BIOLOGICAL	ALLO-ASC-SHEET	Weekly administration
OTHER	Vehicle Control	Weekly administration

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-10-01
• Completion: 2026-04-28
• First posted: 2021-12-15
• Last updated: 2024-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study