Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa

Inclusion Criteria

• •1\. Male or female patients aged between 0 and ≤55 years;
• •Staggered design for patient enrollment:
• •1. at least 3 adult patients (safety assessment 2 weeks after last treatment of third patient),
• •2. at least 3 patients ≥12 to \<18 years (safety assessment 2 weeks after first treatment of third patient),
• •3. at least 3 patients ≥5 to \<12 years (safety assessment 2 weeks after first treatment of third patient), and
• •4. at least 3 patients ≥12 months to \<5 years;
• •5. patients 0 to \<12 months (only in the UK);
• •2\. Diagnosed with RDEB (combined diagnosis by genotype assessment \[mutation analysis\] and correlating phenotype assessment \[wound assessment\]), patients must have a negative immunofluorescence test result on salt-split skin against proteins of the basement membrane at Visit 1 (existing test results will be accepted);
• •3\. Patient is eligible to participate in this clinical trial based on general health condition at the investigator's discretion;
• •US only:
• •Patient is eligible to participate in this clinical trial based on general health condition assessed by specific lab values (Hematology: Absolute neutrophil count \>1000/mm3 and platelet count \>150,000/mcL; Coagulation: PT and PTT \<2x the upper limit of normal for age; Hepatic: AST and ALT \<2x the upper limit of normal for age; Renal: Creatinine \<2x the upper limit of normal for age; Pulmonary: Oxygen saturation \>92% on room air and without supplemental oxygen requirement);
• •4\. Patient/legal representative understands the nature of the procedure and are providing written informed consent prior to any clinical trial procedure;
• •5\. Women of childbearing potential must have a negative urine pregnancy test at Visit 1;
• •6\. Women of childbearing potential and their partner must be willing to use highly effective contraceptive methods during the course of the clinical trial.