Clinical Trial

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

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated June 27, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
To evaluate and further characterize the safety of EB-101 (LZRSE-Col7A1 gene-corrected keratinocyte sheets with type VII collagen \[C7\] expression) for the treatment of large, chronic DEB wounds in new and previously EB-101 treated patients 12 months and older.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-02-02; most recent amendment 2026-04-07.
Status change: Active, Not Recruiting → Completed 2026-04-07
Status change: Recruiting → Active, Not Recruiting 2025-06-24
Status change: Active, Not Recruiting → Recruiting 2023-09-20
Status change: Not Yet Recruiting → Active, Not Recruiting 2023-07-11
Trial Details
NCT Number NCT05725018
Lead Sponsor Abeona Therapeutics, Inc
Conditions Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, RDEB
Enrollment 12 participants
Start Date 2023-04-02
Primary Completion 2025-09-30 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-27