A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB
← catalyst calendarNCT05708677 · readout ≤ 3,481 d
Sponsored by Abeona Therapeutics, Inc (industry) · ABEO — their whole pipeline →.
Phase
—
Status
Enrolling by invitation
Study type
Observational
Enrollment
22estimated
Sites
2
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-02-09 | actual | When the study began enrolling |
| Primary completion | Feb 2036 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2036 | estimated | The whole study's end, after follow-up |
| First posted | 2023-02-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- RDEB
Intervention
- Biological: EB-101 — also filed as pz-cel
Primary outcomes
what the primary-completion date above is the date OFWound Closure
measured 5 years
Pain Severity Scale (Wong-Baker FACES)
measured 5 years
Itch Severity Scale
measured 5 years
Zarit Burden Interview Scale
measured 5 years
Quality of Life in Epidermolysis Bullosa
measured 5 years
Caregiver Global Impression of Change for Pain Scale
measured 5 years
Wound Infection and Adverse Events
measured 5 years
The number of treatment-emergent adverse events.
measured 5 years
Serious Adverse Events
measured 5 years
Incidence of squamous cell carcinoma.
measured 5 years
Replication-competent retrovirus (RCR) status
measured 5 years
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