Evaluation of D-Fi for the Treatment of Wounds Due to DEB
- Registration Number
- NCT06892639
- Lead Sponsor
- Castle Creek Biosciences, LLC.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
- Male or female ≥2 years of age at the Screening visit
- Clinical diagnosis of DEB with confirmation of COL7A1 genetic mutation.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description D-Fi COL7A1 Genetically-Corrected Autologous Fibroblasts D-Fi 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.
- Primary Outcome Measures
Name Time Method 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. Week 26
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (5)
Thomas Jefferson University Dept of Dermatology and Cutaneous Biology
🇺🇸Philadelphia, Pennsylvania, United States
Stanford University School of Medicine, Dermatology
🇺🇸Redwood City, California, United States
Mission Dermatology
🇺🇸Santa Margarita, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States