TerminatedPhase 1/2

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Stopped: Subjects were all in Long-Term Follow Up and were transferred to the ongoing EB-002 study

United States6 participantsStarted 2016-07-01

Plain-language summary

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

Who can participate

Age range7 Years

SexALL

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Inclusion criteria

✓. Age
✓. Phase I: Eighteen (18) years or older.
✓. Phase II: Seven (7) years or older.
✓. Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB)

Exclusion criteria

✕. Medical instability limiting ability to travel to the investigative center.
✕. Active infection with HIV, hepatitis B or hepatitis C or evidence of other systemic infection
✕. Current evidence of metastatic squamous cell carcinoma at the site to be injected
✕. Clinically significant abnormal laboratory result or other significant clinical abnormalities
✕. Receipt of a chemical or biological study product for the specific treatment of RDEB in the past six months

What they're measuring

Adverse Events

Timeframe: 52 weeks post treatment

Trial details

NCT IDNCT02810951

SponsorCastle Creek Biosciences, LLC.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-09-29

Results submitted2021-07-23

View on ClinicalTrials.gov More Epidermolysis Bullosa Dystrophica, Recessive trials