A Multicenter, open-label, single-arm Phase 3b safety study of one-time surgical application of up to 8 autologous, gene-corrected keratinocyte sheets (EB-101) for the treatment of RDEB wounds in approximately 10-12 patients. Patients enrolled will also contribute biopsies to support manufacturing requirements.~Patients will be evaluated at their Day -26 Screening visit, a phone call approximately 14 days after screening, and at Baseline (Day -1) prior to treatment on Day 0. Patients will remain in the hospital, or other suitable medical facility, as determined by the investigator, for observation for up to 5 days (+/- 1 day) following treatment and will be evaluated by phone on Day 14, by telehealth visits on Weeks 4, 8, and 18, and by clinic visits on Weeks 12 and 24.~All patients will be followed through 24 weeks post-treatment.
To evaluate and further characterize the safety of EB-101 (LZRSECol7A1 Engineered Autologous Epidermal Sheets [LEAES]) for the treatment of RDEB wounds in new and previously EB-101 treated patients 6 years and older.