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Gene therapy heals wounds in rare skin disease?

NCT ID NCT04213261

Disease control Sponsor: Castle Creek Biosciences, LLC. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests a gene therapy called FCX-007 for people with recessive dystrophic epidermolysis bullosa, a rare disease that causes fragile skin and painful blisters. The therapy uses the patient's own skin cells, genetically corrected to produce collagen, and injects them into wounds. The study compares treated wounds to untreated ones in just 6 participants, looking for complete healing by 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FCX-007 (dabocemagene autoficel) – a gene-corrected skin cell therapy
What this could lead to
If it works, this could provide a way to heal chronic wounds in people with a severe skin blistering disease, improving quality of life.
What could go wrong
This is a very small early-phase trial with only 6 people, so results may not apply to everyone. The treatment involves injections and there is a risk of immune reactions or the wounds not healing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

6 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Jul 2037

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Male or female ≥2 years of age at the Screening visit. * Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation. Key Exclusion Criteria: * Medical instability limiting ability to travel to the investigative site. * Active infection with human immunodeficiency virus, hepatitis B or hepatitis C. * The presence of COL7 antibodies. * Evidence of systemic infection. * Evidence or history of squamous cell carcinoma at the site to be injected. * Evidence of or history of metastatic squamous cell carcinoma. * Known allergy to any of the constituents of the product. * Female who is pregnant or breastfeeding. * Receipt of a chemical or biological intervention for the specific treatment of RDEB in the past three (3) months prior to screening or anticipated/planned during the screening and treatment period for this study.

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Conditions

The condition(s) this trial relates to.

epidermolysis bullosa dystrophica recessive dystrophic epidermolysis bullosa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recessive dystrophic epidermolysis bullosa

Contacts and locations

Locations

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Dell Children's Medical Group

    Austin, Texas, 78723, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida, 32256, United States

  • Stanford University

    Stanford, California, 94305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.