{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T03:18:15Z","timestamp":1793330295356,"version":"4.5.0"},"reference-count":77,"publisher":"American Society for Clinical Investigation","issue":"22","license":[{"start":{"date-parts":[[2021,11,22]],"date-time":"2021-11-22T00:00:00Z","timestamp":1637539200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"National Institutes of Health (NIH) \/ National Eye Institute","award":["RO1EY025794,R24EY028767"],"award-info":[{"award-number":["RO1EY025794,R24EY028767"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,11,22]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND<\/jats:title>\n                    <jats:p>\n                      Recessive dystrophic epidermolysis bullosa (RDEB) is a rare, devastating, and life-threatening inherited skin fragility disorder that comes about due to a lack of functional type VII collagen, for which no effective therapy exists. ABCB5\n                      <jats:sup>+<\/jats:sup>\n                      dermal mesenchymal stem cells (ABCB5\n                      <jats:sup>+<\/jats:sup>\n                      MSCs) possess immunomodulatory, inflammation-dampening, and tissue-healing capacities. In a\n                      <jats:italic>Col7a1<\/jats:italic>\n                      <jats:sup>\u2013\/\u2013<\/jats:sup>\n                      mouse model of RDEB, treatment with ABCB5\n                      <jats:sup>+<\/jats:sup>\n                      MSCs markedly extended the animals\u2019 lifespans.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>\n                      In this international, multicentric, single-arm, phase I\/IIa clinical trial, 16 patients (aged 4\u201336 years) enrolled into 4 age cohorts received 3 i.v. infusions of 2 \u00d7 10\n                      <jats:sup>6<\/jats:sup>\n                      ABCB5\n                      <jats:sup>+<\/jats:sup>\n                      MSCs\/kg on days 0, 17, and 35. Patients were followed up for 12 weeks regarding efficacy and 12 months regarding safety.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      At 12 weeks, statistically significant median (IQR) reductions in the Epidermolysis Bullosa Disease Activity and Scarring Index activity (EBDASI activity) score of 13.0% (2.9%\u201330%;\n                      <jats:italic>P<\/jats:italic>\n                      = 0.049) and the Instrument for Scoring Clinical Outcome of Research for Epidermolysis Bullosa clinician (iscorEB\u2011c) score of 18.2% (1.9%\u201339.8%;\n                      <jats:italic>P<\/jats:italic>\n                      = 0.037) were observed. Reductions in itch and pain numerical rating scale scores were greatest on day 35, amounting to 37.5% (0.0%\u201342.9%;\n                      <jats:italic>P<\/jats:italic>\n                      = 0.033) and 25.0% (\u20138.4% to 46.4%;\n                      <jats:italic>P<\/jats:italic>\n                      = 0.168), respectively. Three adverse events were considered related to the cell product: 1 mild lymphadenopathy and 2 hypersensitivity reactions. The latter 2 were serious but resolved without sequelae shortly after withdrawal of treatment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>\n                      This trial demonstrates good tolerability, manageable safety, and potential efficacy of i.v. ABCB5\n                      <jats:sup>+<\/jats:sup>\n                      MSCs as a readily available disease-modifying therapy for RDEB and provides a rationale for further clinical evaluation.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>TRIAL REGISTRATION<\/jats:title>\n                    <jats:p>Clinicaltrials.gov NCT03529877; EudraCT 2018-001009-98.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>FUNDING<\/jats:title>\n                    <jats:p>The trial was sponsored by RHEACELL GmbH &amp; Co. KG. Contributions by NYF and MHF to this work were supported by the NIH\/National Eye Institute (NEI) grants RO1EY025794 and R24EY028767.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1172\/jci.insight.151922","type":"journal-article","created":{"date-parts":[[2021,10,19]],"date-time":"2021-10-19T12:02:31Z","timestamp":1634644951000},"source":"Crossref","is-referenced-by-count":56,"title":["Clinical trial of ABCB5+ mesenchymal stem cells for recessive dystrophic epidermolysis bullosa"],"prefix":"10.1172","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2331-8981","authenticated-orcid":true,"given":"Dimitra","family":"Kiritsi","sequence":"first","affiliation":[{"name":"Department of Dermatology, Medical Center \u2013 University of Freiburg, Faculty of Medicine, Freiburg, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathrin","family":"Dieter","sequence":"additional","affiliation":[{"name":"RHEACELL GmbH & Co. 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