Evaluation of D-Fi for the Treatment of Wounds Due to DEB

NCT06892639 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CCB-EB-304
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Dystrophic Epidermolysis Bullosa

Keywords

DEB

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Biological: D-Fi

Interventions

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.

D-Fi COL7A1 Genetically-Corrected Autologous Fibroblasts

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥2 years of age at the Screening visit
• Clinical diagnosis of DEB with confirmation of COL7A1 genetic mutation.

You may not qualify if:

• Medical instability limiting ability to travel to the investigative site.
• Active infection with human immunodeficiency virus, hepatitis B or hepatitis C.
• The presence of clinically significant COL7 antibodies.
• Evidence of systemic infection.
• Known allergy to any of the constituents of the product.
• Female who is pregnant or breastfeeding.

Sponsors & Collaborators

• Castle Creek Biosciences, LLC.: lead
• Prosoft Clinical: collaborator

Study Sites (4)

Stanford University School of Medicine, Dermatology

Redwood City, California, 94063, United States

Location

Mission Dermatology

Santa Margarita, California, 92688, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Epidermolysis Bullosa Dystrophica

Condition Hierarchy (Ancestors)

Epidermolysis Bullosa; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Skin Diseases, Vesiculobullous

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-patient Randomized and Controlled, Open-label, Rater-Blinded, Multi-center

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 25, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 1, 2042
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)