{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,13]],"date-time":"2026-11-13T05:27:40Z","timestamp":1794547660546,"version":"4.9.1"},"reference-count":28,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,7,23]],"date-time":"2025-07-23T00:00:00Z","timestamp":1753228800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010377","name":"National Institute for Health and Care Excellence","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010377","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100012360","name":"Heart of England NHS Foundation Trust","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100012360","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","award":["127963"],"award-info":[{"award-number":["127963"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013786","name":"Cure EB","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013786","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","thelancet.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["eClinicalMedicine"],"published-print":{"date-parts":[[2025,10]]},"DOI":"10.1016\/j.eclinm.2025.103417","type":"journal-article","created":{"date-parts":[[2025,8,15]],"date-time":"2025-08-15T08:06:00Z","timestamp":1755245160000},"page":"103417","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":3,"special_numbering":"C","title":["Mesenchymal stromal cell infusions of umbilical cord-derived mesenchymal stromal cells in children with recessive dystrophic epidermolysis bullosa (MissionEB): a randomised, double-blind, placebo controlled, crossover, phase 3 trial with an internal phase 1 dose de-escalation phase"],"prefix":"10.1016","volume":"88","author":[{"given":"Maria L.","family":"Bageta","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9944-719X","authenticated-orcid":false,"given":"Pablo","family":"Lopez-Balboa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matt","family":"Bursnall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Glover","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7870-2844","authenticated-orcid":false,"given":"Kate","family":"Hutchence","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana","family":"Papaioannou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Biggs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Julious","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5126-8822","authenticated-orcid":false,"given":"Isabelle","family":"Wilson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Tappenden","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Turton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shamila","family":"Ditta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malobi","family":"Ogboli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie-Louise","family":"Lovgren","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pratima","family":"Poudel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muna","family":"Nadeem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John A.","family":"McGrath","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy","family":"Cooper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriela","family":"Petrof","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1738-8008","authenticated-orcid":false,"given":"Anna E.","family":"Martinez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"2","key":"10.1016\/j.eclinm.2025.103417_bib1","first-page":"20","article-title":"The natural history of severe recessive dystrophic epidermolysis bullosa \u2013 4 phases which may help determine different therapeutic approaches","volume":"2","author":"Bageta","year":"2021","journal-title":"J Dermatol Venereol"},{"issue":"4","key":"10.1016\/j.eclinm.2025.103417_bib2","doi-asserted-by":"crossref","first-page":"614","DOI":"10.1111\/bjd.18921","article-title":"Consensus reclassification of inherited epidermolysis bullosa and other disorders with skin fragility","volume":"183","author":"Has","year":"2020","journal-title":"Br J Dermatol"},{"issue":"1","key":"10.1016\/j.eclinm.2025.103417_bib3","doi-asserted-by":"crossref","first-page":"78","DOI":"10.1038\/s41572-020-0210-0","article-title":"Epidermolysis bullosa","volume":"6","author":"Bardhan","year":"2020","journal-title":"Nat Rev Dis Primers"},{"issue":"5","key":"10.1016\/j.eclinm.2025.103417_bib4","doi-asserted-by":"crossref","first-page":"843","DOI":"10.1111\/bjd.20958","article-title":"The epidemiology of epidermolysis bullosa in England and Wales: data from the national epidermolysis bullosa database","volume":"186","author":"Petrof","year":"2022","journal-title":"Br J Dermatol"},{"issue":"1","key":"10.1016\/j.eclinm.2025.103417_bib5","doi-asserted-by":"crossref","first-page":"664","DOI":"10.1038\/s41467-025-55934-7","article-title":"Systems immunology integrates the complex endotypes of recessive dystrophic epidermolysis bullosa","volume":"16","author":"Hirt","year":"2025","journal-title":"Nat Commun"},{"issue":"3","key":"10.1016\/j.eclinm.2025.103417_bib6","doi-asserted-by":"crossref","DOI":"10.1016\/j.humimm.2024.110805","article-title":"Unravelling drivers of cutaneous squamous cell carcinoma in recessive dystrophic epidermolysis bullosa","volume":"85","author":"Santucci","year":"2024","journal-title":"Hum Immunol"},{"issue":"8","key":"10.1016\/j.eclinm.2025.103417_bib7","doi-asserted-by":"crossref","DOI":"10.1111\/exd.15146","article-title":"Unveiling the value of C-reactive protein as a severity biomarker and the IL4\/IL13 pathway as a therapeutic target in recessive dystrophic epidermolysis bullosa: a multiparametric cross-sectional study","volume":"33","author":"Quintana-Castanedo","year":"2024","journal-title":"Exp Dermatol"},{"key":"10.1016\/j.eclinm.2025.103417_bib8","doi-asserted-by":"crossref","first-page":"455","DOI":"10.2147\/TCRM.S386923","article-title":"Innovations in the treatment of dystrophic epidermolysis bullosa (DEB): current landscape and prospects","volume":"19","author":"Hou","year":"2023","journal-title":"Ther Clin Risk Manag"},{"issue":"5","key":"10.1016\/j.eclinm.2025.103417_bib9","doi-asserted-by":"crossref","first-page":"1200","DOI":"10.1007\/s12015-024-10697-4","article-title":"Advances in treatments for epidermolysis bullosa (EB): emphasis on stem cell-based therapy","volume":"20","author":"Raoufinia","year":"2024","journal-title":"Stem Cell Rev Rep"},{"issue":"9","key":"10.1016\/j.eclinm.2025.103417_bib10","doi-asserted-by":"crossref","first-page":"2319","DOI":"10.1038\/jid.2015.158","article-title":"Potential of systemic allogeneic mesenchymal stromal cell therapy for children with recessive dystrophic epidermolysis bullosa","volume":"135","author":"Petrof","year":"2015","journal-title":"J Invest Dermatol"},{"issue":"2","key":"10.1016\/j.eclinm.2025.103417_bib11","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1111\/dth.12305","article-title":"Treatment of dystrophic epidermolysis bullosa with bone marrow non-hematopoeitic stem cells: a randomized controlled trial","volume":"29","author":"El-Darouti","year":"2016","journal-title":"Dermatol Ther"},{"issue":"2","key":"10.1016\/j.eclinm.2025.103417_bib12","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1016\/j.jaad.2019.11.038","article-title":"Phase I\/II open-label trial of intravenous allogeneic mesenchymal stromal cell therapy in adults with recessive dystrophic epidermolysis bullosa","volume":"83","author":"Rashidghamat","year":"2020","journal-title":"J Am Acad Dermatol"},{"issue":"22","key":"10.1016\/j.eclinm.2025.103417_bib13","doi-asserted-by":"crossref","DOI":"10.1172\/jci.insight.151922","article-title":"Clinical trial of ABCB5+ mesenchymal stem cells for recessive dystrophic epidermolysis bullosa","volume":"6","author":"Kiritsi","year":"2021","journal-title":"JCI Insight"},{"issue":"7","key":"10.1016\/j.eclinm.2025.103417_bib14","doi-asserted-by":"crossref","first-page":"782","DOI":"10.1016\/j.jcyt.2023.01.015","article-title":"ABCB5+ mesenchymal stromal cells facilitate complete and durable wound closure in recessive dystrophic epidermolysis bullosa","volume":"25","author":"Dieter","year":"2023","journal-title":"Cytotherapy"},{"issue":"2","key":"10.1016\/j.eclinm.2025.103417_bib15","doi-asserted-by":"crossref","DOI":"10.1172\/jci.insight.143606","article-title":"Intravenous allogeneic umbilical cord blood-derived mesenchymal stem cell therapy in recessive dystrophic epidermolysis bullosa patients","volume":"6","author":"Lee","year":"2021","journal-title":"JCI Insight"},{"issue":"1","key":"10.1016\/j.eclinm.2025.103417_bib16","doi-asserted-by":"crossref","DOI":"10.1080\/09546634.2024.2419931","article-title":"Systemic treatment of recessive dystrophic epidermolysis bullosa with mesenchymal stromal cells: a scoping review of the literature and conclusions for future clinical research","volume":"35","author":"Niebergall-Roth","year":"2024","journal-title":"J Dermatol Treat"},{"issue":"2","key":"10.1016\/j.eclinm.2025.103417_bib17","doi-asserted-by":"crossref","first-page":"195","DOI":"10.4252\/wjsc.v6.i2.195","article-title":"Umbilical cord-derived mesenchymal stem cells: their advantages and potential clinical utility","volume":"6","author":"Nagamura-Inoue","year":"2014","journal-title":"World J Stem Cells"},{"issue":"3","key":"10.1016\/j.eclinm.2025.103417_bib18","doi-asserted-by":"crossref","first-page":"429","DOI":"10.3109\/14653241003587637","article-title":"Replenishment of type VII collagen and re-epithelialization of chronically ulcerated skin after intradermal administration of allogeneic mesenchymal stromal cells in two patients with recessive dystrophic epidermolysis bullosa","volume":"12","author":"Conget","year":"2010","journal-title":"Cytotherapy"},{"issue":"5","key":"10.1016\/j.eclinm.2025.103417_bib19","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2024-089857","volume":"15","author":"Bageta","year":"2025","journal-title":"BMJ Open"},{"issue":"11","key":"10.1016\/j.eclinm.2025.103417_bib20","doi-asserted-by":"crossref","first-page":"2108","DOI":"10.1016\/j.jid.2023.05.024","article-title":"Type VII collagen deficiency in the oncogenesis of cutaneous squamous cell carcinoma in dystrophic epidermolysis bullosa","volume":"143","author":"South","year":"2023","journal-title":"J Invest Dermatol"},{"issue":"1","key":"10.1016\/j.eclinm.2025.103417_bib21","doi-asserted-by":"crossref","first-page":"80","DOI":"10.1093\/bjd\/ljad077","article-title":"Heterogeneity of reported outcomes in epidermolysis bullosa clinical research: a scoping review as a first step towards outcome harmonization","volume":"189","author":"Korte","year":"2023","journal-title":"Br J Dermatol (1951)"},{"issue":"19","key":"10.1016\/j.eclinm.2025.103417_bib22","doi-asserted-by":"crossref","DOI":"10.3390\/ijms251910270","article-title":"Current status of biomedical products for gene and cell therapy of recessive dystrophic epidermolysis bullosa","volume":"25","author":"Zorina","year":"2024","journal-title":"Int J Mol Sci"},{"issue":"24","key":"10.1016\/j.eclinm.2025.103417_bib23","doi-asserted-by":"crossref","first-page":"2211","DOI":"10.1056\/NEJMoa2206663","article-title":"Trial of Beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa","volume":"387","author":"Guide","year":"2022","journal-title":"N Engl J Med"},{"issue":"4","key":"10.1016\/j.eclinm.2025.103417_bib24","doi-asserted-by":"crossref","first-page":"780","DOI":"10.1038\/s41591-022-01737-y","article-title":"In vivo topical gene therapy for recessive dystrophic epidermolysis bullosa: a phase 1 and 2 trial","volume":"28","author":"Gurevich","year":"2022","journal-title":"Nat Med"},{"key":"10.1016\/j.eclinm.2025.103417_bib25","series-title":"U.S. FDA approves ZEVASKYN\u2122 (prademagene zamikeracel), the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB) [press release]","year":"2025"},{"issue":"3","key":"10.1016\/j.eclinm.2025.103417_bib26","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1093\/bjd\/ljae200","article-title":"Towards a roadmap for COSEB: the next steps in harmonization of outcomes for epidermolysis bullosa","volume":"191","author":"Korte","year":"2024","journal-title":"Br J Dermatol (1951)"},{"issue":"4","key":"10.1016\/j.eclinm.2025.103417_bib27","doi-asserted-by":"crossref","first-page":"692","DOI":"10.1111\/jdv.13953","article-title":"The Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI): grading disease severity and assessing responsiveness to clinical change in epidermolysis bullosa","volume":"31","author":"Jain","year":"2017","journal-title":"J Eur Acad Dermatol Venereol"},{"issue":"5","key":"10.1016\/j.eclinm.2025.103417_bib28","doi-asserted-by":"crossref","first-page":"1128","DOI":"10.1111\/bjd.16350","article-title":"Reliability and validity of the instrument for scoring clinical outcomes of research for epidermolysis bullosa (iscorEB)","volume":"178","author":"Bruckner","year":"2018","journal-title":"Br J Dermatol"}],"container-title":["eClinicalMedicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2589537025003499?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2589537025003499?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,11,13]],"date-time":"2026-11-13T05:06:14Z","timestamp":1794546374000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2589537025003499"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10]]},"references-count":28,"alternative-id":["S2589537025003499"],"URL":"https:\/\/doi.org\/10.1016\/j.eclinm.2025.103417","relation":{},"ISSN":["2589-5370"],"issn-type":[{"value":"2589-5370","type":"print"}],"subject":[],"published":{"date-parts":[[2025,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Mesenchymal stromal cell infusions of umbilical cord-derived mesenchymal stromal cells in children with recessive dystrophic epidermolysis bullosa (MissionEB): a randomised, double-blind, placebo controlled, crossover, phase 3 trial with an internal phase 1 dose de-escalation phase","name":"articletitle","label":"Article Title"},{"value":"eClinicalMedicine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.eclinm.2025.103417","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Crown Copyright \u00a9 2025 Published by Elsevier Ltd.","name":"copyright","label":"Copyright"}],"article-number":"103417"}}