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 range

7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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