EB-101 Treatment for New and Previously Treated Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Inclusion Criteria: Clinical diagnosis of RDEB Age 6 years and older; Willing and able to give consent/assent; if under the age of 18 years, guardian(s) is/are willing and able to give consent; Positive expression of NC1+ amino-terminal fragment of C7 in the skin; Two confirmed RDEB C7 mutations with recessive inheritance patterns (or confirmation that parents don't have any evidence of dominant disease); Able to undergo adequate anesthesia during EB-101 treatment; All women of childbearing potential must have a negative urine pregnancy test and use a reliable birth control method throughout the duration of the study and for 24 Weeks post treatment; On stable pain medication regimen for at least 30 days prior to Screening; Must have at least one wound site that meets all of the following criteria: An area ≥20 cm2 Present for ≥6 months Stage 2 wound defined as an open skin wound with partial thickness loss of dermis that has not extended through the dermis into subcutaneous tissue Exclusion Criteria: Medical instability limiting ability to travel to the study site or undergo EB-101 treatment; 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 or history of immune response to C7 by indirect immunofluorescence (IIF) or enzyme-linked immunosorbent assay; Evidence of systemic infection; Current evidence or a history of squamous cell carcinoma (SCC) in the area that will undergo EB-101 application; Active drug or alcohol addiction; Hypersensitivity to vancomycin or amikacin; Receipt of chemical or biological investigational therapy for the specific treatment of RDEB in the 3 months prior to EB-101 application; Positive pregnancy test or breast-feeding; Inability to properly follow protocol assessments and protect keratinocyte sheet sites as determined by the Principal Investigator; Grade 3 clinical event or laboratory abnormality at Day 0. Abnormalities such as esophageal strictures, anemia, low albumin, and pain/itch are expected in RDEB patients, and these abnormalities will not exclude a patient; Unwillingness or inability to provide 4-biopsies or inability to manufacture patient's keratinocytes for use in EB-101 application.