Drugs / Dabocemagene Autoficel
Dabocemagene Autoficel
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02810951 | Jul 2016 → Sep 2020 | recessive dystrophic epidermolysis bullosa | Castle Creek Biosciences, LLC. | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06892639 | Mar 2025 → Sep 2027 expected | epidermolysis bullosa dystrophica | Castle Creek Biosciences, LLC. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04213261 | Jun 2020 → Jan 2023 overdue | recessive dystrophic epidermolysis bullosa | Castle Creek Biosciences, LLC. | Active not recruiting | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-10-21 | Castle Creek Biosciences, LLC. | Castle Creek Biosciences Awarded FDA Orphan Products Development Grant to Support DeFi-RDEB, a Pivotal Phase 3 Study of FCX-007 Investigational Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa castlecreekbio.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dabocemagene autoficel | “Evaluation of Dabocemagene Autoficel (D-Fi; FCX-007; Genetically Modified Autologous Human Dermal Fibroblasts) for the Treatment of Wounds Due to Dystropic Epidermolysis Bullosa” NCT06892639 ↗1“FCX-007 (dabocemagene autoficel; see below for FCX-007 description)” NCT04213261 ↗ |
| Known as | D-Fi | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06892639 ↗ |
| Known as | FCX-007 | “Evaluation of Dabocemagene Autoficel (D-Fi; FCX-007; Genetically Modified Autologous Human Dermal Fibroblasts) for the Treatment of Wounds Due to Dystropic Epidermolysis Bullosa” NCT06892639 ↗ |
| Modality | Cell therapy | “FCX-007 is a genetically modified cell product” NCT02810951 ↗ |
| Route | Other | “FCX-007 cell suspension is injected intradermally.” NCT02810951 ↗ |