Evaluation of D-Fi for the Treatment of Wounds Due to DEB
Key facts
- Who runs it
- Castle Creek Biosciences, LLC.
- Where
- Aurora, Redwood City, Santa Margarita, and Worcester, United StatesSee the 4 sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 3
- People taking part
- 32 people, planned
- Started
- 27 Mar 2025
- Expected to end
- Feb 2042
- Type of study
- Interventional
- Treatments tested
- D-Fi
- Record updated
- 13 March 2026
Who can take part
- Age
- 2 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Male or female ≥2 years of age at the Screening visit
- Clinical diagnosis of DEB with confirmation of COL7A1 genetic mutation
Who cannot take part
- The presence of clinically significant COL7 antibodies
- Active infection with human immunodeficiency virus, hepatitis B or hepatitis C
- Evidence of systemic infection
- Known allergy to any of the constituents of the product
- Medical instability limiting ability to travel to the investigative site
- Female who is pregnant or breastfeeding
Where in United States
- Children's Hospital ColoradoAurora, United States
- Stanford University School of Medicine, DermatologyRedwood City, United States
- Mission DermatologySanta Margarita, United States
- University of MassachusettsWorcester, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- D-Fi COL7A1 Genetically-Corrected Autologous FibroblastsTreatment being tested
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.
Treatment: D-Fi
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 13 March 2026