This observational registry aims to evaluate long-term safety and wound healing durability for up to 15 years in people with recessive dystrophic epidermolysis bullosa (RDEB) who were treated with prademagene zamikeracel (EB-101, pz-cel) in the post-marketing setting. It also records the occurrence of any malignancy after treatment, regardless of type or location. Participants are followed annually, mostly through remote data collection; eligibility requires the ability to give consent or assent, with guardian consent for those under 18, and prior pz-cel treatment in the post-marketing setting.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Willing and able to give consent/assent; if under the age of 18, guardian(s) is(are) willing and able to give consent. * Patients who received treatment with prademagene zamikeracel in the post-marketing setting. Exclusion Criteria: • Inability to properly follow the protocol as determined by the Principal Investigator (PI).