NCT05708677

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)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 22 (estimated)
• Sponsor: Abeona Therapeutics, Inc · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 visits.

Conditions

• RDEB

Interventions

Type	Name	Description
BIOLOGICAL	EB-101	This is non-interventional and follows patients treated with EB-101

Timeline

• Start date: 2021-02-09
• Primary completion: 2036-02-01
• Completion: 2036-08-01
• First posted: 2023-02-01
• Last updated: 2024-06-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study