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

Launched by ABEONA THERAPEUTICS, INC · Jan 23, 2023

Keywords

ClinConnect Summary

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 pho...

Gender

ALL

Eligibility 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

Trial Officials