{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T16:36:51Z","timestamp":1789835811884,"version":"4.0.1"},"reference-count":25,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2022,7,10]],"date-time":"2022-07-10T00:00:00Z","timestamp":1657411200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100019408","name":"Marcus Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100019408","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Develop Med Child Neuro"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>To evaluate safety and motor function after treatment with allogeneic umbilical cord blood (AlloCB) or umbilical cord tissue\u2010derived mesenchymal stromal cells (hCT\u2010MSC) in children with cerebral palsy (CP).<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>Ninety\u2010one children (52 males, 39 females; median age 3\u2009years 7\u2009months [range 2\u20135\u2009years]) with CP due to hypoxic\u2013ischemic encephalopathy, stroke, or periventricular leukomalacia were randomized to three arms: (1) the AlloCB group received 10\u00a0\u00d7\u200910<jats:sup>7<\/jats:sup> AlloCB total nucleated cells (TNC) per kilogram at baseline (<jats:italic>n<\/jats:italic>\u00a0=\u200931); (2) the hCT\u2010MSC group received 2\u2009\u00d7\u200910<jats:sup>6<\/jats:sup> hCT\u2010MSC at baseline, 3\u2009months, and 6\u2009months (<jats:italic>n<\/jats:italic>\u00a0=\u200928); (3) the natural history control group received 10\u2009\u00d7\u200910<jats:sup>7<\/jats:sup> AlloCB TNC per kilogram at 12\u2009months (<jats:italic>n<\/jats:italic>\u00a0=\u200931). Motor function was assessed with the Gross Motor Function Measure\u201066 (GMFM\u201066) and Peabody Developmental Motor Scale, Second Edition.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Infusions (<jats:italic>n<\/jats:italic>\u00a0=\u2009143) were well tolerated, with eight infusion reactions (three in the AlloCB group, five in hCT\u2010MSC) and no other safety concerns. At 12\u2009months, the mean differences (95% confidence intervals [CI]) between actual and expected changes in GMFM\u201066 score were AlloCB 5.8 points (3.4\u20138.2), hCT\u2010MSC 4.3 (2.2\u20136.4), and natural history 3.1 (1.4\u20135.0). In exploratory, post hoc analysis, the mean GMFM\u201066 score (95% CI) of the hCT\u2010MSC group was 1.4 points higher than natural history (\u22121.1 to 4.0; <jats:italic>p<\/jats:italic>\u00a0=\u20090.27), and the AlloCB group was 3.3 points higher than natural history (0.59\u20135.93; <jats:italic>p<\/jats:italic>\u00a0=\u20090.02) after adjustment for baseline Gross Motor Function Classification System level, GMFM\u201066 score, and etiology.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interpretation<\/jats:title><jats:p>High\u2010dose AlloCB is a potential cell therapy for CP and should be further tested in a randomized, blinded, placebo\u2010controlled trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>What this paper adds<\/jats:title><jats:p>\n<jats:list list-type=\"bullet\">\n<jats:list-item><jats:p>Unrelated donor allogeneic umbilical cord blood (AlloCB) and human umbilical cord tissue\u2010derived mesenchymal stromal cell infusion is safe in young children with cerebral palsy.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Significant changes in motor function were not observed 6\u2009months after treatment.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>One year later, treatment with AlloCB was associated with greater increases in Gross Motor Function Measure\u201066 scores.<\/jats:p><\/jats:list-item>\n<\/jats:list><\/jats:p><\/jats:sec>","DOI":"10.1111\/dmcn.15325","type":"journal-article","created":{"date-parts":[[2022,7,11]],"date-time":"2022-07-11T04:24:41Z","timestamp":1657513481000},"page":"1477-1486","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":41,"title":["Motor function and safety after allogeneic cord blood and cord tissue\u2010derived mesenchymal stromal cells in cerebral palsy: An open\u2010label, randomized trial"],"prefix":"10.1111","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8085-1013","authenticated-orcid":false,"given":"Jessica M.","family":"Sun","sequence":"first","affiliation":[{"name":"Marcus Center for Cellular Cures Duke University School of Medicine  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura E.","family":"Case","sequence":"additional","affiliation":[{"name":"Department of Physical and Occupational Therapy Duke University School of Medicine  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colleen","family":"McLaughlin","sequence":"additional","affiliation":[{"name":"Marcus Center for Cellular Cures Duke University School of Medicine  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia","family":"Burgess","sequence":"additional","affiliation":[{"name":"Marcus Center for Cellular Cures Duke University School of Medicine  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalie","family":"Skergan","sequence":"additional","affiliation":[{"name":"Marcus Center for Cellular Cures Duke University School of Medicine  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sydney","family":"Crane","sequence":"additional","affiliation":[{"name":"Marcus Center for Cellular Cures Duke University School of Medicine  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5469-1092","authenticated-orcid":false,"given":"Joan M.","family":"Jasien","sequence":"additional","affiliation":[{"name":"Division of Pediatric Neurology Duke University School of Medicine  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0363-8715","authenticated-orcid":false,"given":"Mohamad A.","family":"Mikati","sequence":"additional","affiliation":[{"name":"Division of Pediatric Neurology Duke University School of Medicine  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jesse","family":"Troy","sequence":"additional","affiliation":[{"name":"Marcus Center for Cellular Cures Duke University School of Medicine  Durham NC USA"},{"name":"Department of Biostatistics and Bioinformatics Duke University School of Medicine  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanne","family":"Kurtzberg","sequence":"additional","affiliation":[{"name":"Marcus Center for Cellular Cures Duke University School of Medicine  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,7,10]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/dmcn.12865"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annepidem.2016.01.001"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/dmcn.14011"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/ppe.12299"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/sctm.17-0102"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/sctm.20-0470"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/dmcn.14789"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2015-08-666990"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.92.22.10119"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/sctm.19-0434"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.2522\/ptj.20070314"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.288.11.1357"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4067"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/0962280210395740"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.apmr.2015.07.024"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-8749.2008.03150.x"},{"issue":"10","key":"e_1_2_9_18_1","first-page":"1041","article-title":"Seven days post\u2010injury fate and effects of genetically labelled adipose\u2010derived mesenchymal cells on a rat traumatic brain injury experimental model","volume":"32","author":"Dori I","year":"2017","journal-title":"Histol Histopathol"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1089\/scd.2016.0108"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0000000000001864"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.12659\/MSM.900512"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmri.27286"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13287-020-02020-y"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1089\/scd.2015.0074"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/stem.1304"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcyt.2015.02.010"}],"container-title":["Developmental Medicine &amp; Child Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dmcn.15325","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dmcn.15325","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dmcn.15325","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,19]],"date-time":"2023-08-19T21:38:38Z","timestamp":1692481118000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/dmcn.15325"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7,10]]},"references-count":25,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["10.1111\/dmcn.15325"],"URL":"https:\/\/doi.org\/10.1111\/dmcn.15325","archive":["Portico"],"relation":{},"ISSN":["0012-1622","1469-8749"],"issn-type":[{"value":"0012-1622","type":"print"},{"value":"1469-8749","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,7,10]]},"assertion":[{"value":"2022-03-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-05-20","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-07-10","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}