NCT02810951|TerminatedPhase 1/2ResultsDMC
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Subjects were all in Long-Term Follow Up and were transferred to the ongoing EB-002 study
A Phase I/II Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Office of Orphan Products Development
interventional
6
1 country
2
Study Start
July 1, 2016
Actual (reported)Primary Completion
September 29, 2020
Actual (reported)Study Completion
April 18, 2022
Actual (reported)The purpose of this study is to evaluate the safety of FCX-007, evaluate Type VII collagen (COL7) expression and the presence of anchoring fibrils and to analyze wound healing as a result of FCX-007 administration in subjects with recessive dystrophic epidermolysis bullosa (RDEB). Funding Source- FDA OOPD
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 18, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 13, 2016
Actual (reported)June 23, 2016
Actual (reported)July 1, 2016
Actual (reported)September 29, 2020
Actual (reported)September 16, 2021
Actual (reported)April 18, 2022
Actual (reported)Adverse Events
Number of subjects with adverse events.
52 weeks post treatment
Complete Wound Closure
Through Week 52
In Phase I, a target of three adult subjects will be enrolled into Group A and a target of three adult subjects will be enrolled into Group B. In Phase II the study will target enrolling subjects (aged seven (7 years or older) to each arm, but will allow a disproportionate distribution of subjects between Group A and Group B to equal approximately 6 total subjects. All subjects will receive FCX-007 into one or more paired target wounds as well as to intact skin at least one time during the study with a possible second administration pending laboratory results. One wound in each target wound pair will be used as control for efficacy and safety evaluations.
FCX-007 is a genetically modified cell product obtained from the subject's own skin cells (Autologous fibroblasts). The cells are expanded and genetically modified to produce functional COL7. FCX-007 cell suspension is injected intradermally.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Stanford University
Stanford, California, 94305, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Small number of subjects analyzed for proof of mechanism analyses
6 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2016
First Posted
June 23, 2016
Study Start
July 1, 2016
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
September 29, 2020
Actual (reported)Study Completion
April 18, 2022
Actual (reported)Last Updated
February 8, 2023
Results First Posted
September 16, 2021
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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