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

Inclusion Criteria:

1. Male or female subjects from 6 months of age with a diagnosis of RDEB confirmed bygenetic testing or by a skin biopsy with immunofluorescence mapping
2. Subject is eligible to participate in this clinical trial based on general healthcondition;
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 providewritten 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 willingto use highly effective contraceptive methods during the course of the entire clinicaltrial.

Exclusion Criteria:

1. Any current tumor diseases, including squamous cell carcinoma and basal cellcarcinoma;
2. Any known allergies to components of the IP or premedication;
3. Patient/legal representative anticipated to be unwilling or unable to comply with therequirements of the protocol;
4. Pregnant or lactating women;
5. Current or previous (within 30 days of screening) treatment with another IP, orparticipation 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 clinicalcontraindications like an uncontrolled or poorly controlled mental health condition ofthe subject and/or his/her legal representative that could impact on patient's safetyor 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.