At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 11 enrolled
Drug / intervention
EB-101biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
VIITAL: A Phase 3 Study of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
In Brief
A Phase 3 clinical trial evaluating EB-101 for Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa. Completed, enrolled 11 participants across 2 sites.
Detailed Summary
The purpose of this trial is to evaluate safety and efficacy of surgical application of EB-101 (autologous, gene-corrected keratinocyte sheets) as a treatment of recessive dystrophic epidermolysis bullosa (RDEB).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartJan 2020
First PostedJan 2020
Primary CompletionOct 2022
TodayJul 2026
First PostedJan 13, 2020
Enrollment StartJan 10, 2020
Primary CompletionOct 18, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.5 years ago
Interventions
EB-101biological
autologous RDEB keratinocytes isolated from skin biopsies and transduced with a recombinant retrovirus containing a full-length COL7A1 expression cassette for C7