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Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over)

A Double-blind, Randomized, Placebo-controlled, Interventional, Multicenter, Phase III Clinical Trial to Investigate the Safety and Efficacy of ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs) on Epidermolysis Bullosa (EB)

NCT05464381•RHEACELL GmbH & Co. KG

View on ClinicalTrials.gov

Summary

The aim of this clinical trial is to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo. An additional baseline-controlled open-label arm will be included to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with JEB and to RDEB subjects \< 1 year.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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);
+2 more criteria

Locations (16)

Sanatorio Mater Dei

Buenos Aires, Argentina

EB-Haus Austria; Salzburger Landeskliniken (SALK)

Salzburg, Austria

Fundacion Debra Chile

Santiago, Chile

Universitaetsklinik fuer Dermatologie und Allergologie

Nice, France

Hospital Necker-Enfants Malades

Paris, France

Service de Dermatologie Hospital Saint-Louis

Paris, France

Andreas Syggros Hospital of Cutaneous Venereal Diseases

Athens, Greece

Venereal & Skin Diseases Hospital of Thessaloniki

Thessaloniki, Greece

Semmelweis Egyetem

Budapest, Hungary

UOSD Pediatria-Alta Intensita di Curà, Ospedale Maggiore

Milan, Italy

Key Dates

Start Date

June 13, 2023

Primary Completion Date

August 29, 2025

Completion Date

January 1, 2027

Last Updated

December 10, 2025

Enrollment

ACTUAL participants

Conditions

Epidermolysis Bullosa

Interventions

allo-APZ2-OTS

DRUG

Placebo

DRUG

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Epidermolysis Bullosa, DystrophicEpidermolysis Bullosa, Junctional

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over)

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez

Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling

Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa

Gentamicin for Junctional Epidermolysis Bullosa

Thera-Clean® Microbubbles System in Patients With Skin Diseases

Reproductive Options in Inherited Skin Diseases