A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients

Exclusion Criteria

• •1. Medical instability limiting ability to travel to the study site or undergo EB-101 treatment.
• •2. 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.
• •3. (This exclusion criterion was deleted as of Amendment 3.)
• •4. Evidence of systemic infection.
• •5. Current evidence or a history of SCC in the area that will undergo EB-101 application.
• •6. Active drug or alcohol addiction.
• •7. Hypersensitivity to vancomycin or amikacin.
• •8. Receipt of chemical or biological investigational therapy for the specific treatment of DEB in the 3 months prior to EB-101 application.
• •9. Breast-feeding.
• •10. Inability to properly follow protocol assessments and protect keratinocyte sheet sites as determined by the PI.
• •11. Grade 3 clinical event or laboratory abnormality at Day 0. Abnormalities such as esophageal strictures, anemia, low albumin, and pain/itch are expected in severe DEB patients, and these abnormalities will not exclude a patient.
• •12. Unwillingness or inability to provide 4 skin biopsies, or patient's keratinocytes cannot be manufactured for use in EB-101 application.
• •13. Any other circumstance where the PI believes that the patient may not be appropriate for participation in the study.