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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05464381
Other study ID # allo-APZ2-EB-III
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 1, 2023
Est. completion date December 2025

Study information

Verified date February 2023
Source RHEACELL GmbH & Co. KG
Contact Cristina Daniele
Phone T +49 6221 71833-66
Email cristina.daniele@rheacell.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 74
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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); 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, = 21 days 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. Any current tumor diseases, including squamous cell carcinoma and basal cell carcinoma; 2. Any known allergies to components of the IP or premedication; 3. Patient/legal representative anticipated to be unwilling or unable to comply with the requirements of the protocol; 4. Pregnant or lactating women; 5. Current or previous (within 30 days of screening) treatment with another IP, or participation and/or under follow-up in another interventional clinical trial; 6. Previous participation in this clinical trial (except for screening failures); 7. 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; Confidential 8. Employees of the sponsor, or employees or relatives of the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
allo-APZ2-OTS
Allogeneic dermal ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs)
Placebo
Placebo

Locations

Country Name City State
Austria EB-Haus Austria; Salzburger Landeskliniken (SALK) Salzburg

Sponsors (1)

Lead Sponsor Collaborator
RHEACELL GmbH & Co. KG

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects with complete target wound closure Proportion of subjects with complete healing of target wound, determined by the investigator, as compared to baseline 6 months
See also
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