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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06892639 | Evaluation of D-Fi for the Treatment of Wounds Due to DEB | PHASE3 | ACTIVE NOT_RECRUITING | 32 | — | — | Mar 27, 2025 | Feb 1, 2042 | Mar 13, 2026 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| D-Fi COL7A1 Genetically-Corrected Autologous Fibroblasts | EXPERIMENTAL | Intra-subject randomized (paired wounds in each subject receive experimental treatment, D-Fi, or remain untreated). One target wound pair will be identified for each subject. Following pairing, target wounds will be randomly assigned as the treatment wound (D-Fi is administered) or control wound. Subjects will receive intradermal injections of D-Fi in each specified treatment wound in two or more treatment sessions. The first treatment session occurs at Day 1, the second at Week 8/Month 2 and the third at Week 16/Month 4. Additional treatment sessions may occur at Week 26/Month 6, Week 32/Month 8 and Week 40/Month 10 when unclosed treatment wounds may be re-treated, and unclosed control wounds may be treated. |
| Name | Type | Description |
|---|---|---|
| D-Fi | BIOLOGICAL | D-Fi is composed of fibroblasts isolated from the subject's skin biopsies which are genetically corrected with the full length COL7A1 gene encoding for type VII collagen. |
Inclusion Criteria: * Male or female ≥2 years of age at the Screening visit * Clinical diagnosis of DEB with confirmation of COL7A1 genetic mutation. Exclusion Criteria: * Medical instability limiting ability to travel to the investigative site. * Active infection with human immunodeficiency viru...