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

Abeona Therapeutics, Inc

Summary

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

Description

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…

Eligibility

Age range: 6+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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

Interventions

Biological
EB-101
This is non-interventional and follows patients treated with EB-101

Locations (2)

Stanford University
Redwood City, California
University of Massachusetts Medical School
Worcester, Massachusetts