A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa
Public ClinicalTrials.gov record NCT04213261. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Pivotal Phase 3 Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa
Study identification
- NCT ID
- NCT04213261
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Castle Creek Biosciences, LLC.
- Industry
- Enrollment
- 6 participants
Conditions and interventions
Conditions
Interventions
- FCX-007 (dabocemagene autoficel; see below for FCX-007 description) Biological
Biological
Eligibility (public fields only)
- Age range
- 2 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 8, 2020
- Primary completion
- Jan 16, 2023
- Completion
- Jun 30, 2037
- Last update posted
- Mar 17, 2026
2020 – 2037
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Solutions Through Advanced Research, Inc. | Jacksonville | Florida | 32256 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Dell Children's Medical Group | Austin | Texas | 78723 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04213261, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 17, 2026 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04213261 live on ClinicalTrials.gov.