A Phase 3 interventional study of FCX-007 (dabocemagene autoficel; see below for FCX-007 description) in Recessive Dystrophic Epidermolysis Bullosa, sponsored by Castle Creek Biosciences, LLC.. Active, not recruiting at 5 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Castle Creek Biosciences, LLC. · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether administration of FCX-007 in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Recessive Dystrophic Epidermolysis Bullosa.
Funding Source - FDA OOPD
DEFI-RDEB is a multi-center, intra-patient randomized, controlled, open-label, Phase 3 study of FCX-007 for the treatment of persistent non-healing and recurrent RDEB wounds in approximately 24 subjects. Each subject will serve as his/her own control. Each subject's target wounds will be paired then randomized to receive FCX-007 (treatment wound) or remain untreated (control wound). Up to three target wound pairs will be identified for each subject.
Subjects will receive intradermal injections of FCX-007 in each specified treatment wound in two or more treatment sessions. The first treatment session occurs at Day 1 and the second at Week 12/Month 3. Additional treatment sessions may occur at Week 24/Month 6 and Week 36/Month 9 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 FCX-007 injections.
77 studies on the registry are indexed under Epidermolysis Bullosa Dystrophica; 20 are open to participants now.
This study's enrollment of 6 is below the median of 9 across 54 interventional studies indexed under Epidermolysis Bullosa Dystrophica.
Browse Epidermolysis Bullosa Dystrophica studies →Castle Creek Biosciences, LLC. is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Intra-subject randomized (paired wounds in each subject receive experimental treatment, FCX-007, or remain untreated). Up to three target wound pairs will be identified for each subject. Following pairing, target wounds will be randomly assigned as the treatment wound (FCX-007 is administered) or control wound. Subjects will receive intradermal injections of FCX-007 in each specified treatment wound in two or more treatment sessions. The first treatment session occurs at Day 1 and the second at Week 12/Month 3. Additional treatment sessions may occur at Week 24/Month 6 and Week 36/Month 9 when unclosed treatment wounds may be re-treated, and unclosed control wounds may be treated.
Biological: FCX-007 (dabocemagene autoficel; see below for FCX-007 description)
FCX-007 is comprised of fibroblasts isolated from the subject's skin biopsies which are genetically corrected with the full length COL7A1 gene encoding for type VII collagen.
Complete Wound Closure of the First Wound Pair at Week 24
Complete wound closure of the first wound pair (treated vs. control)
Time frame: Week 24
Complete Wound Closure of the First Wound Pair at Week 12
Complete wound closure of first wound pair (treated vs. control)
Time frame: Week 12
Complete Wound Closure of All Wound Pairs at Week 24
Complete wound closure
Time frame: Week 24
Complete Wound Closure of All Wound Pairs at Week 12
Complete wound closure
Time frame: Week 12
| Milestone | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | Control (no Treatment) |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
Complete wound closure of the first wound pair (treated vs. control)
| wound | FCX-007 Treated Success | Control Success |
|---|---|---|
| Complete Wound Closure of the First Wound Pair at Week 24 | 1 | 0 |
Complete wound closure of first wound pair (treated vs. control)
| wound | FCX-007 Treated Success | Control Success |
|---|---|---|
| Complete Wound Closure of the First Wound Pair at Week 12 | 1 | 1 |
Complete wound closure
| wound | FCX-007 Treated Success | Control Success |
|---|---|---|
| Complete Wound Closure of All Wound Pairs at Week 24 | 1 | 2 |
Complete wound closure
| wound | FCX-007 Treated Success | Control Success |
|---|---|---|
| Complete Wound Closure of All Wound Pairs at Week 12 | 1 | 3 |
Collected over Treatment-emergent adverse events (AEs), regardless of relationship to FCX-007, are those reported from start of treatment to end of treatment period (Week 48). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts | 0/6 (0%) | 2/6 (33.3%) | 2/6 (33.3%) |
| Event | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts |
|---|---|
| Lower limb fractureInjury, poisoning and procedural complications | 1/6 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/6 |
| Pulmonary infarctionRespiratory, thoracic and mediastinal disorders | 1/6 |
| Event | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts |
|---|---|
| TachycardiaCardiac disorders | 1/6 |
| Injection site painGeneral disorders | 1/6 |
| Growth retardationMusculoskeletal and connective tissue disorders | 1/6 |
| OsteoporosisMusculoskeletal and connective tissue disorders | 1/6 |
| PruritusSkin and subcutaneous tissue disorders | 1/6 |
| Superficial vein thrombosisVascular disorders | 1/6 |
| Injection site haemorrhageGeneral disorders | 1/6 |
| Injection site swellingGeneral disorders | 1/6 |
| COVID-19Infections and infestations | 1/6 |
| Skin infectionInfections and infestations | 1/6 |
| Age, Categorical(Participants) | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts |
|---|---|
| <=18 years | 3 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Age, Continuous(years) | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts |
|---|---|
| Mean | 28.7 ± 16.77 |
| Sex: Female, Male(Participants) | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts |
|---|---|
| Female | 1 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | FCX-007 COL7A1 Genetically-Corrected Autologous Fibroblasts |
|---|---|
| United States | 6 |
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Epidermolysis Bullosa Dystrophica→
Castle Creek Biosciences, LLC.