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Disease manifestations include severe and debilitating wounds, aggressive squamous cell carcinomas, and premature death; however, there are currently no approved therapies. This Phase 1\/2a, open-label study evaluated the long-term efficacy and safety of gene-corrected autologous keratinocyte grafts (EB-101) for chronic RDEB wounds.\n<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Autologous keratinocytes were harvested from participants with severe RDEB, transduced with a retrovirus containing the full-length <jats:italic>COL7A1<\/jats:italic> gene, and grown into 5\u2009\u00d7\u20097\u00a0cm (35 cm<jats:sup>2<\/jats:sup>) sheets. Gene-corrected keratinocyte sheets were then transplanted onto chronic RDEB wounds present for\u2009\u2265\u200912\u00a0weeks.\n<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Seven adult participants with severe RDEB were grafted with six sheets each (42 total sheets) onto wounds and followed for a mean of 5.9\u00a0years (range 4\u20138\u00a0years). Long-term improvements in wound healing and symptoms were observed. At year five, 70% (21\/30) of treated sites demonstrated\u2009\u2265\u200950% wound healing compared to baseline by investigator global assessment. No sites with\u2009\u2265\u200950% wound healing were painful or pruritic, compared to 67% (6\/9) of sites with\u2009&lt;\u200950% wound healing (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) at year five. Grafts were well-tolerated throughout long-term follow-up. No serious adverse events related to treatment were reported over a mean of 5.9\u00a0years of follow-up. No persistent systemic autoimmunity against type VII collagen or replication-competent retrovirus infections were identified, and no participants developed squamous cell carcinomas related to treatment during long-term follow-up.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Treatment with EB-101 appears safe and efficacious, and produces long-term improvements in wound healing, pain, and itch for RDEB patients. Results from the Phase 3 randomized controlled trial are forthcoming.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>\n                           <jats:italic>Trial registration<\/jats:italic>\n                        <\/jats:title>\n                <jats:p>ClinicalTrials.gov, NCT01263379. Registered December 15, 2010. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01263379\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01263379<\/jats:ext-link><\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13023-022-02546-9","type":"journal-article","created":{"date-parts":[[2022,10,17]],"date-time":"2022-10-17T09:03:48Z","timestamp":1665997428000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":44,"title":["Long-term safety and efficacy of gene-corrected autologous keratinocyte grafts for recessive dystrophic epidermolysis bullosa"],"prefix":"10.1186","volume":"17","clinical-trial-number":[{"clinical-trial-number":"nct01263379","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4395-2752","authenticated-orcid":false,"given":"Jodi Y.","family":"So","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4267-6776","authenticated-orcid":false,"given":"Jaron","family":"Nazaroff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9356-2237","authenticated-orcid":false,"given":"Chinonso V.","family":"Iwummadu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5176-2932","authenticated-orcid":false,"given":"Nicki","family":"Harris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2813-3089","authenticated-orcid":false,"given":"Emily S.","family":"Gorell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2918-3931","authenticated-orcid":false,"given":"Shivali","family":"Fulchand","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8502-3775","authenticated-orcid":false,"given":"Irene","family":"Bailey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9997-1066","authenticated-orcid":false,"given":"Daniel","family":"McCarthy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2814-4220","authenticated-orcid":false,"given":"Zurab","family":"Siprashvili","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5528-8046","authenticated-orcid":false,"given":"M. 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