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

Inclusion Criteria

• Male or female subjects with a diagnosis of RDEB or JEB confirmed by genetic testing or by a skin biopsy with immunofluorescence mapping (IFM);
• Subject is eligible to participate in this clinical trial based on general health condition;
• Subject with a target wound meeting the following criteria: 5-50 cm2, ≥ 21 days and < 9 months, no signs of acute infection;
• Patient/legal representative understands the nature of the procedure and provide written informed consent/assent prior to any clinical trial procedure;
• Women of childbearing potential must have a negative urine pregnancy test at Visit
• 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

• Any current tumor diseases, including squamous cell carcinoma and basal cell carcinoma;
• Any known allergies to components of the IP or premedication;
• Patient/legal representative anticipated to be unwilling or unable to comply with the requirements of the protocol;
• Pregnant or lactating women;
• Current or previous (within 30 days of screening) treatment with another IP, or participation and/or under follow-up in another interventional clinical trial;
• Previous participation in this clinical trial (except for screening failures);
• 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
• Employees of the sponsor, or employees or relatives of the investigator.