Epidermolysis Bullosa Clinical Trial
Official title:
A Phase 3b Study for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) in New and Previously EB-101 Treated Patients
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.
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. ;
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