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Gene therapy mends wounds in rare 'butterfly skin' disease

NCT ID NCT06892639

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a treatment called D-Fi, made from a person's own skin cells that are genetically modified to produce a missing protein. It aims to see if injecting these cells into wounds helps them close completely compared to standard care alone. The trial includes 32 children and adults with dystrophic epidermolysis bullosa, a condition that causes fragile skin and chronic wounds.

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

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Feb 2042

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.

Inclusion Criteria: * Male or female ≥2 years of age at the Screening visit * Clinical diagnosis of DEB with confirmation of COL7A1 genetic mutation. 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 clinically significant COL7 antibodies. * Evidence of systemic infection. * Known allergy to any of the constituents of the product. * Female who is pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

dystrophic epidermolysis bullosa, dog epidermolysis bullosa dystrophica

As listed by the trial registrant

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

Dystrophic epidermolysis bullosa

Contacts and locations

Locations

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Mission Dermatology

    Santa Margarita, California, 92688, United States

  • Stanford University School of Medicine, Dermatology

    Redwood City, California, 94063, United States

  • University of Massachusetts

    Worcester, Massachusetts, 01655, United States

More trials for these conditions

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