Clinical trial NCT06892639: Evaluation of D-Fi for the Treatment of Wounds Due to DEB
Official title: Evaluation of Dabocemagene Autoficel (D-Fi; FCX-007; Genetically Modified Autologous Human Dermal Fibroblasts) for the Treatment of Wounds Due to Dystropic Epidermolysis Bullosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dystrophic Epidermolysis Bullosa
Keywords: DEB
Lead sponsor: Castle Creek Biosciences, LLC.
Sponsor class: INDUSTRY
Collaborators: name: Prosoft Clinical
First posted: 2025-03-25
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intra-patient Randomized and Controlled, Open-label, Rater-Blinded, Multi-center
Primary purpose: TREATMENT

Brief 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.

Detailed description: CCB-EB-304 is a multi-center, intra-patient randomized and controlled, open-label, rater-blinded Phase 3 study of D-Fi for the treatment of persistent non-healing and recurrent DEB wounds in approximately 32 subjects. Each subject will serve as his/her own control. Each subject's target wounds will be paired then randomized to receive D-Fi (treatment wound) or remain untreated (control wound). One target wound pair will be identified for each subject.

Subjects will receive intradermal injections of D-Fi in each specified treatment wound in three 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 and Week 32/Month 8 and Week 40/Month 10 when unclosed treatment wounds may be re-treated, and unclosed control wounds may be treated. Safety and efficacy assessments will occur at scheduled intervals through Week 48/Month 12, when the treatment period is completed, and a long-term safety follow-up period (through 15 years) commences for subjects who have received one or more D-Fi injections.

Eligibility criteria: 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 virus, hepatitis B or hepatitis C.
* The presence of COL7 antibodies.
* Evidence of systemic infection.
* Known allergy to any of the constituents of the product.
* Female who is pregnant or breastfeeding.

Primary outcomes:
measure: The difference in Complete (100%) Wound Closure of the Target Wound Pair at either Week 22 (Visit 6), and Week 24 (Visit 7) or at Week 24 (Visit 7) and Week 26 (Visit 8) as assessed by a Blinded Assessor.
timeFrame: Week 26
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University School of Medicine, Dermatology
state: California
city: Santa Margarita
country: United States
facility: Mission Dermatology
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Philadelphia
country: United States
facility: Thomas Jefferson University Dept of Dermatology and Cutaneous Biology
state: Pennsylvania
Study officials:
References: