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Stem cell therapy offers hope for children with butterfly skin

NCT ID NCT05464381

Disease control Sponsor: RHEACELL GmbH & Co. KG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 stem cell treatment for epidermolysis bullosa, a rare disease causing fragile skin that blisters easily. About 91 people with two types of EB will receive the cells or a placebo through an IV. The main goal is to see if the treatment can safely close stubborn 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

91 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Jan 2027

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Male or female subjects with a diagnosis of RDEB or JEB confirmed by genetic testing or by a skin biopsy with immunofluorescence mapping (IFM). A minimal body weight of at least 5 kg is required; 2. Subject is eligible to participate in this clinical trial based on general health condition; 3. Subject with a target wound meeting the following criteria: 5-50 cm2, and \< 9 months, no signs of acute infection; 4. Patient/legal representative understands the nature of the procedure and provide written informed consent/assent prior to any clinical trial procedure; 5. Women of childbearing potential must have a negative urine pregnancy test at Visit 1. Women of childbearing potential, male participants, and their partner must be willing to use highly effective contraceptive methods during the course of the entire clinical trial. Exclusion Criteria: 1. Signs and/or a history of skin precancerous and cancerous lesions at screening or any current tumor diseases, including squamous cell carcinoma and basal cell carcinoma; 2. Known chronic lung disease; 3. Clinically significant laboratory values for coagulation and thrombocytes at screening; 4. Thromboembolic events of any grade in medical history; 5. Immunoreactions of any grade in medical history; 6. Any known allergies to components of the IP or premedication; 7. Patient/legal representative anticipated to be unwilling or unable to comply with the requirements of the protocol; 8. Pregnant or lactating women; 9. Current or previous (within 30 days of screening) treatment with another IP, or participation and/or under follow-up in another interventional clinical trial; 10. Previous participation in this clinical trial (except for screening failures); 11. Clinically significant or unstable concurrent disease or other clinical contraindications like an uncontrolled or poorly controlled mental health condition of the subject and/or his/her legal representative that could impact on patient's safety or interfere with study compliance such as inability to attend scheduled study visits; 12. Employees of the sponsor, or employees or relatives of the investigator.

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Conditions

The condition(s) this trial relates to.

epidermolysis bullosa junctional epidermolysis bullosa recessive dystrophic epidermolysis bullosa

As listed by the trial registrant

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

Epidermolysis bullosa

Contacts and locations

Locations

  • Andreas Syggros Hospital of Cutaneous Venereal Diseases

    Athens, Greece

  • Centro Hospitalar e Universitario de Comibra HUC

    Coimbra, Portugal

  • Department of Dermatology, National Cheng Kung University

    Tainan, Taiwan

  • EB-Haus Austria; Salzburger Landeskliniken (SALK)

    Salzburg, 5020, Austria

  • Fundacion Debra Chile

    Santiago, Chile

  • Great Ormond Street Hospital (GOSH)

    London, United Kingdom

  • Hospital La Paz

    Madrid, Spain

  • Hospital Necker-Enfants Malades

    Paris, France

  • Medical Concierge Centrum Medyczne

    Warsaw, Poland

  • Ospedale Pediatrico Bambin Gesu

    Roma, Italy

  • Sanatorio Mater Dei

    Buenos Aires, Argentina

  • Semmelweis Egyetem

    Budapest, Hungary

  • Service de Dermatologie Hospital Saint-Louis

    Paris, France

  • UOSD Pediatria-Alta Intensita di Curà, Ospedale Maggiore

    Milan, Italy

  • Universitaetsklinik fuer Dermatologie und Allergologie

    Nice, France

  • Venereal & Skin Diseases Hospital of Thessaloniki

    Thessaloniki, Greece

More trials for these conditions

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