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ACTIVE NOT RECRUITING Phase 3

A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

NCT04213261 · View on ClinicalTrials.gov ↗

Study Summary

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

Interventions

  • BIOLOGICAL FCX-007 (dabocemagene autoficel; see below for FCX-007 description)

Study Locations (5)

California

  • Stanford University — Stanford

Colorado

  • Children's Hospital Colorado — Aurora

Florida

  • Solutions Through Advanced Research, Inc. — Jacksonville

Minnesota

  • Mayo Clinic — Rochester

Texas

  • Dell Children's Medical Group — Austin

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2020-06-09
Est. Completion 2037-07
Phase Phase 3

Sponsor

Castle Creek Biosciences

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04213261

The ClinicalTrials.gov registry entry for NCT04213261 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Castle Creek Biosciences, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Recessive Dystrophic Epidermolysis Bullosa appearing as the primary indexed condition, and to 1 intervention — of which FCX-007 (dabocemagene autoficel; see below for FCX-007 description) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04213261 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04213261 about?

NCT04213261 is a clinical study titled "A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa". 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

What is the current status of trial NCT04213261?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 6 participants. The study started on 2020-06-09. Estimated completion is 2037-07.

What conditions does trial NCT04213261 study?

This clinical trial studies the following conditions: Recessive Dystrophic Epidermolysis Bullosa. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04213261?

The interventions under investigation include: FCX-007 (dabocemagene autoficel; see below for FCX-007 description) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04213261?

This trial is sponsored by Castle Creek Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04213261 being conducted?

This trial has 5 study locations across California, Colorado, Florida, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial