Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over)
NCT ID: NCT05464381
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
91 participants
INTERVENTIONAL
2023-06-13
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Verum
allo-APZ2-OTS
Allogeneic dermal ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs)
Placebo
Placebo
Placebo
Interventions
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allo-APZ2-OTS
Allogeneic dermal ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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RHEACELL GmbH & Co. KG
INDUSTRY
Responsible Party
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Locations
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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
Ospedale Pediatrico Bambin Gesu
Roma, , Italy
Medical Concierge Centrum Medyczne
Warsaw, , Poland
Centro Hospitalar e Universitario de Comibra HUC
Coimbra, , Portugal
Hospital La Paz
Madrid, , Spain
Department of Dermatology, National Cheng Kung University
Tainan, , Taiwan
Great Ormond Street Hospital (GOSH)
London, , United Kingdom
Countries
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Other Identifiers
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allo-APZ2-EB-III
Identifier Type: -
Identifier Source: org_study_id
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