Evaluation of Dabocemagene Autoficel (D-Fi; FCX-007; Genetically Modified Autologous Human Dermal Fibroblasts) for the Treatment of Wounds Due to Dystropic Epidermolysis Bullosa
Status: Active_not_recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to determine whether administration of D-Fi in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Dystrophic Epidermolysis Bullosa.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:
• Male or female ≥2 years of age at the Screening visit
• Clinical diagnosis of DEB with confirmation of COL7A1 genetic mutation.
Locations
United States
California
Stanford University School of Medicine, Dermatology
Redwood City
Mission Dermatology
Santa Margarita
Colorado
Children's Hospital Colorado
Aurora
Massachusetts
University of Massachusetts
Worcester
Time Frame
Start Date: 2025-03-27
Completion Date: 2042-02
Participants
Target number of participants: 32
Treatments
Experimental: D-Fi COL7A1 Genetically-Corrected Autologous Fibroblasts
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.
Related Therapeutic Areas
Sponsors
Leads: Castle Creek Biosciences, LLC.
Collaborators: Prosoft Clinical