A Long-Term Safety Follow-up Registry for Patients Who Received Treatment With Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa (RDEB) in the Post-Marketing Setting
← catalyst calendarNCT07700966 · readout ≤ 6,828 d
Sponsored by Abeona Therapeutics, Inc (industry) · ABEO — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
250estimated
Sites
4
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 | 2025-07-25 | actual | When the study began enrolling |
| Primary completion | Apr 2045 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2045 | estimated | The whole study's end, after follow-up |
| First posted | 2026-07-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Recessive Dystrophic Epidermolysis Bullosa
Intervention
- Combination product: Prademagene Zamikeracel — also filed as EB-101, Pz-cel
Primary outcomes
what the primary-completion date above is the date OFThe number and incidence of treatment-related malignancies.
measured From enrollment to 15 years post-treatment
The number and incidence of treatment-emergent SAEs, including systematic and wound specific SAEs
measured From enrollment to 15 years post-treatment
The number and incidences of treatment-related SAEs related to pz-cel, including systematic and wound-specific SAEs.
measured From enrollment to 15 years post-treatment
The number and incidence of positive RCR testing results required for AEs and SAEs where retroviral infection is a consideration
measured From enrollment to 15 years post-treatment
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