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Gene-Corrected skin cells may offer lasting relief for 'Butterfly Children'

NCT ID NCT05708677

Disease control Sponsor: Abeona Therapeutics, Inc 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study follows people with recessive dystrophic epidermolysis bullosa (RDEB), a severe blistering skin disease, who previously received an experimental treatment called EB-101. EB-101 uses gene-corrected skin cells to help wounds heal. Researchers will track wound closure, pain, itch, and quality of life for up to 54 months to see if the benefits last.

What this could mean

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

Active substance
a gene-corrected skin cell therapy called EB-101 (pz-cel)
What this could lead to
If successful, this could show that a single treatment with EB-101 provides lasting wound healing and symptom relief for people with RDEB.
What could go wrong
This is a small, long-term follow-up study with no control group, so results may not prove the treatment works for everyone. There is also a risk of infections or skin cancer over time.

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.

Participants

About 22 people

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

Started

Feb 2021

Expected to finish

Aug 2036

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.

Who is studied

Patient with previous EB-101 treatment

Ages

6 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: * Willing and able to give consent/assent; * If under the age of 18, guardian(s) is/are willing and able to give consent; * Prior study treatment with EB-101. Exclusion Criteria: * Inability to properly follow protocol as determined by the Principal Investigator

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Conditions

The condition(s) this trial relates to.

recessive dystrophic epidermolysis bullosa

As listed by the trial registrant

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

RDEB

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Stanford University

    Redwood City, California, 94063, United States

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01605, United States

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