Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04227106 | Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) | PHASE3 | COMPLETED | 11 | — | — | Jan 10, 2020 | Oct 18, 2022 | Dec 5, 2022 | 2 | United States |
Proportion of RDEB wound sites with ≥50% healing from Baseline in treated versus untreated wounds
Associated with wound dressing change assessed by the mean differences in scores of the Wong-Baker FACES scale between treated and untreated wounds
| Arm | Type | Description |
|---|---|---|
| EB-101 | EXPERIMENTAL | One-time surgical application of EB-101 on up to 6 chronic, RDEB wounds |
| Name | Type | Description |
|---|---|---|
| EB-101 | BIOLOGICAL | autologous RDEB keratinocytes isolated from skin biopsies and transduced with a recombinant retrovirus containing a full-length COL7A1 expression cassette for C7 |
Inclusion Criteria: * Clinical diagnosis of RDEB; * Age 6 years or older, willing and able to give consent/assent; * If under the age of 18, guardian(s) is/are willing and able to give consent; * Positive expression of the non-collagenous region 1 of the type 7 collagen protein (NC1+) in the skin; ...