Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Inclusion Criteria: * Clinical diagnosis of RDEB; * Age 6 years or older, willing and able to give consent/assent; * If under the age of 18, guardian(s) is/are willing and able to give consent; * Positive expression of the non-collagenous region 1 of the type 7 collagen protein (NC1+) in the skin; * Two confirmed RDEB C7 mutations with recessive inheritance patterns (or confirmation that parents don't have any evidence of dominant disease); * At least 40 cm2 areas of chronically wounded area on the trunk and/or extremities suitable for EB-101 application (open erosions); * Able to undergo adequate anesthesia during EB-101 application; * Must have at least two matched, eligible wound sites (one pair); * Wound sites must: * Have an area ≥20 cm2, * Present for ≥6 months, and * Stage 2 wound; * Women of childbearing potential must use a reliable birth control method throughout the duration of the study and for 6 months post treatment; * Negative pregnancy test; * Must be on stable pain medication regimen at least 30 days prior to Screening Exclusion Criteria: * Medical instability limiting ability to travel to the study site; * The presence of medical illness expected to complicate participation and/or compromise the safety of this technique, such as active infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C; * Evidence of immune response to C7 by indirect immunofluorescence (IIF); * Evidence of systemic infection; * Current evidence o…