A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB

A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

A Long-Term Extension Study for Participants Previously Treated with EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

This is an open-label, long-term, follow-up study in participants from prior interventional trials involving surgical application of gene-corrected keratinocyte sheets (EB-101) for the treatment of RDEB wound sites. Up to 22 participants will be enrolled in this study, with follow-up through at least 5 years post treatment. Patient-reported outcomes and safety will be assessed throughout the study, and where applicable, compared to Baseline of the preceding interventional EB-101 trial. Upon completion, participants will transfer to an annual monitoring program for additional 10 years of phone visits.

Inclusion Criteria:

• Willing and able to give consent/assent;
• If under the age of 18, guardian(s) is/are willing and able to give consent;
• Prior study treatment with EB-101.

Exclusion Criteria:

• Inability to properly follow protocol as determined by the Principal Investigator