Trial · NCT04213261
A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa
NCT04213261, Phase 3, Active not recruiting, Castle Creek Biosciences, LLC.; results first posted 2024-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa. Trials, record NCT04213261. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04213261
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa
- NCT number
- NCT04213261
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 6 participants, actual
- Lead sponsor
- Castle Creek Biosciences, LLC.
- Conditions
- Recessive Dystrophic Epidermolysis Bullosa
- Interventions
- FCX-007 (dabocemagene autoficel; see below for FCX-007 description)
- First posted
- 2019-12-30
- Last updated
- 2026-03-18
- Results first posted
- 2024-04-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Wound Closure of the First Wound Pair at Week 24 | Week 24 | Complete wound closure of the first wound pair (treated vs. control) |
| Secondary | Complete Wound Closure of the First Wound Pair at Week 12 | Week 12 | Complete wound closure of first wound pair (treated vs. control) |
| Secondary | Complete Wound Closure of All Wound Pairs at Week 24 | Week 24 | Complete wound closure |
| Secondary | Complete Wound Closure of All Wound Pairs at Week 12 | Week 12 | Complete wound closure |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Wound Closure of the First Wound Pair at Week 24 | Week 24 | wound | NUMBER | |
| SECONDARY | Complete Wound Closure of the First Wound Pair at Week 12 | Week 12 | wound | NUMBER | |
| SECONDARY | Complete Wound Closure of All Wound Pairs at Week 24 | Week 24 | wound | NUMBER | |
| SECONDARY | Complete Wound Closure of All Wound Pairs at Week 12 | Week 12 | wound | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Wound Closure of the First Wound Pair at Week 24 | FCX-007 Treated Success | 1 | wound | ||
| Complete Wound Closure of the First Wound Pair at Week 24 | Control Success | 0 | wound | ||
| Complete Wound Closure of the First Wound Pair at Week 12 | FCX-007 Treated Success | 1 | wound | ||
| Complete Wound Closure of the First Wound Pair at Week 12 | Control Success | 1 | wound | ||
| Complete Wound Closure of All Wound Pairs at Week 24 | FCX-007 Treated Success | 1 | wound | ||
| Complete Wound Closure of All Wound Pairs at Week 24 | Control Success | 2 | wound | ||
| Complete Wound Closure of All Wound Pairs at Week 12 | FCX-007 Treated Success | 1 | wound | ||
| Complete Wound Closure of All Wound Pairs at Week 12 | Control Success | 3 | wound |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 6 | 13 |
| Overall Study | STARTED | Control (no Treatment) | 6 | 13 |
| Overall Study | COMPLETED | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 6 | 13 |
| Overall Study | COMPLETED | Control (no Treatment) | 6 | 13 |
| Overall Study | NOT COMPLETED | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 0 | 0 |
| Overall Study | NOT COMPLETED | Control (no Treatment) | 0 | 0 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tachycardia | Cardiac disorders | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 1 | 6 | 1 |
| other | Injection site pain | General disorders | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 1 | 6 | 2 |
| other | Growth retardation | Musculoskeletal and connective tissue disorders | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 1 | 6 | 1 |
| other | Osteoporosis | Musculoskeletal and connective tissue disorders | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 1 | 6 | 1 |
| other | Pruritus | Skin and subcutaneous tissue disorders | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 1 | 6 | 1 |
| other | Superficial vein thrombosis | Vascular disorders | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 1 | 6 | 1 |
| other | Injection site haemorrhage | General disorders | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 1 | 6 | 1 |
| other | Injection site swelling | General disorders | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 1 | 6 | 1 |
| other | COVID-19 | Infections and infestations | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 1 | 6 | 1 |
| other | Skin infection | Infections and infestations | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 1 | 6 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 0 | 6 |
| Total, other adverse events | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 2 | 6 |
| Total, serious adverse events | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 2 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04213261
GET https://conductscience.org/api/trials/v1/NCT04213261/registered