{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T16:18:20Z","timestamp":1791908300537,"version":"4.3.4"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2022,1,28]],"date-time":"2022-01-28T00:00:00Z","timestamp":1643328000000},"content-version":"vor","delay-in-days":283,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2021,4,20]],"date-time":"2021-04-20T00:00:00Z","timestamp":1618876800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2021,4,20]],"date-time":"2021-04-20T00:00:00Z","timestamp":1618876800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"name":"Korean Health and Medical Technology R&D Program, Ministry for Health, Welfare, and Family Affairs, Republic of Korea","award":["HI12C1821"],"award-info":[{"award-number":["HI12C1821"]}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>We previously demonstrated the safety and feasibility of mesenchymal stem cell (MSC) transplantation for bronchopulmonary dysplasia (BPD) in preterm infants in a phase I clinical trial. We thus investigated the therapeutic efficacy of MSCs for BPD in premature infants. A phase II double-blind, randomized, placebo-controlled clinical trial was conducted on preterm infants at 23 to 28 gestational weeks (GW) receiving mechanical ventilator support with respiratory deterioration between postnatal days 5 and 14. Infants were stratified by 23 to 24 GW and 25 to 28 GW and randomly allocated (1:1) to receive stem cells (1\u2009\u00d7\u2009107 cells\/kg, n\u00a0=\u00a033) or placebo (n\u00a0=\u00a033). Although the inflammatory cytokines in the tracheal aspirate fluid were significantly reduced with MSCs, the primary outcome of death or severe\/moderate BPD in the control group (18\/33, 55%) was not significantly improved with MSC transplantation (17\/33, 52%). In the subgroup analysis, the secondary outcome of severe BPD was significantly improved from 53% (8\/15) to 19% (3\/16) with MSC transplantation in the 23 to 24 GW group but not in the 25 to 28 GW subgroup. In summary, although MSC transplantation might be safe and feasible, this small study was underpowered to detect its therapeutic efficacy in preterm infants at 23 to 28 GW. Accordingly, we are now conducting an additional larger and controlled phase II clinical trial focusing on infants at 23 to 24 GW (NCT03392467). ClinicalTrials.gov identifier: NCT01828957.<\/jats:p>","DOI":"10.1002\/sctm.20-0330","type":"journal-article","created":{"date-parts":[[2021,4,20]],"date-time":"2021-04-20T09:42:41Z","timestamp":1618911761000},"page":"1129-1137","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":117,"title":["Stem Cells for Bronchopulmonary Dysplasia in Preterm Infants: A Randomized Controlled Phase II Trial"],"prefix":"10.1093","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1821-3173","authenticated-orcid":false,"given":"So Yoon","family":"Ahn","sequence":"first","affiliation":[{"name":"Department of Pediatrics \u00a0Samsung Medical Center and Sungkyunkwan University School of Medicine, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yun Sil","family":"Chang","sequence":"additional","affiliation":[{"name":"Department of Pediatrics \u00a0Samsung Medical Center and Sungkyunkwan University School of Medicine, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myung Hee","family":"Lee","sequence":"additional","affiliation":[{"name":"Statistics and Data Center \u00a0Research Institute for Future Medicine, Samsung Medical Center, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Se In","family":"Sung","sequence":"additional","affiliation":[{"name":"Department of Pediatrics \u00a0Samsung Medical Center and Sungkyunkwan University School of Medicine, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Byong Sop","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Asan Medical Center \u00a0University of Ulsan, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ki Soo","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Asan Medical Center \u00a0University of Ulsan, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ai-Rhan","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Asan Medical Center \u00a0University of Ulsan, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Won Soon","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Pediatrics \u00a0Samsung Medical Center and Sungkyunkwan University School of Medicine, Seoul, South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,4,20]]},"reference":[{"key":"2022022810533293700_sct312925-bib-0001","doi-asserted-by":"crossref","first-page":"1946","DOI":"10.1056\/NEJMra067279","article-title":"Chronic lung disease after premature birth","volume":"357","author":"Baraldi","year":"2007","journal-title":"N Engl J 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