Using D-Fi to treat wounds from Dystrophic Epidermolysis Bullosa
Evaluation of Dabocemagene Autoficel (D-Fi; FCX-007; Genetically Modified Autologous Human Dermal Fibroblasts) for the Treatment of Wounds Due to Dystropic Epidermolysis Bullosa
This study is testing if a new treatment called D-Fi can help heal wounds in people with Dystrophic Epidermolysis Bullosa better than leaving some wounds untreated.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Castle Creek Biosciences, LLC. Industry-sponsored |
| Locations | 5 sites (Redwood City, California and 4 other locations) |
| Trial ID | NCT06892639 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial evaluates the effectiveness of D-Fi in improving wound healing for patients with Dystrophic Epidermolysis Bullosa (DEB). The study involves approximately 32 subjects who will receive intradermal injections of D-Fi in designated treatment wounds, while paired control wounds will remain untreated. Each subject serves as their own control, allowing for a direct comparison of treatment effects. Safety and efficacy will be monitored over a 12-month treatment period, followed by a long-term safety follow-up lasting up to 15 years.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 2 years and older with a confirmed diagnosis of DEB and a COL7A1 genetic mutation.
Not a fit: Patients with medical instability, active infections, or known allergies to the treatment components may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance wound healing for patients suffering from DEB.
How similar studies have performed: While this approach is novel in the context of DEB, similar studies using targeted therapies for wound healing have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Redwood City, California and 4 other locations
- Stanford University School of Medicine, Dermatology — Redwood City, California, United States (Recruiting)
- Mission Dermatology — Santa Margarita, California, United States (Recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- University of Massachusetts — Worcester, Massachusetts, United States (Recruiting)
- Thomas Jefferson University Dept of Dermatology and Cutaneous Biology — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Chief Medical Officer, MD
- Email: medinfo@castlecreekbio.com
- Phone: 484-352-3055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.