{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,13]],"date-time":"2025-05-13T21:59:58Z","timestamp":1747173598591,"version":"3.40.5"},"reference-count":31,"publisher":"Cambridge University Press (CUP)","issue":"9","license":[{"start":{"date-parts":[[2022,8,22]],"date-time":"2022-08-22T00:00:00Z","timestamp":1661126400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/www.cambridge.org\/core\/terms"}],"content-domain":{"domain":["cambridge.org"],"crossmark-restriction":true},"short-container-title":["Cardiol Young"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec id=\"S1047951122002633_as1\"><jats:title>Objective:<\/jats:title><jats:p>The Mesenchymal Stromal Cell Delivery through Cardiopulmonary Bypass in Pediatric Cardiac Surgery study is a prospective, open-label, single-centre, dose-escalation phase 1 trial assessing the safety\/feasibility of delivering mesenchymal stromal cells to neonates\/infants during cardiac surgery. Outcomes will be compared with historical data from a similar population. We aim to define an optimal control group for use in the Mesenchymal Stromal Cell Delivery through Cardiopulmonary Bypass in Pediatric Cardiac Surgery trial.<\/jats:p><\/jats:sec><jats:sec id=\"S1047951122002633_as2\"><jats:title>Methods:<\/jats:title><jats:p>Consecutive patients who underwent a two-ventricle repair without aortic arch reconstruction within the first 6 months of life between 2015 and 2020 were studied using the same inclusion\/exclusion criteria as the Phase 1 Mesenchymal Stromal Cell Delivery through Cardiopulmonary Bypass in Pediatric Cardiac Surgery trial (n = 169). Patients were allocated into one of three diagnostic groups: ventricular septal defect type, Tetralogy of Fallot type, and transposition of the great arteries type. To determine era effect, patients were analysed in two groups: Group A (2015\u20132017) and B (2018\u20132020). In addition to biological markers, three post-operative scoring methods (inotropic and vasoactive-inotropic scores and the Pediatric Risk of Mortality-III) were assessed.<\/jats:p><\/jats:sec><jats:sec id=\"S1047951122002633_as3\"><jats:title>Results:<\/jats:title><jats:p>All values for three scoring systems were consistent with complexity of cardiac anomalies. Max inotropic and vasoactive-inotropic scores demonstrated significant differences between all diagnosis groups, confirming high sensitivity. Despite no differences in surgical factors between era groups, we observed lower inotropic and vasoactive-inotropic scores in group B, consistent with improved post-operative course in recent years at our centre.<\/jats:p><\/jats:sec><jats:sec id=\"S1047951122002633_as4\"><jats:title>Conclusions:<\/jats:title><jats:p>Our studies confirm max inotropic and vasoactive-inotropic scores as important quantitative measures after neonatal\/infant cardiac surgery. Clinical outcomes should be compared within diagnostic groupings. The optimal control group should include only patients from a recent era. This initial study will help to determine the sample size of future efficacy\/effectiveness studies.<\/jats:p><\/jats:sec>","DOI":"10.1017\/s1047951122002633","type":"journal-article","created":{"date-parts":[[2022,8,22]],"date-time":"2022-08-22T06:16:10Z","timestamp":1661148970000},"page":"1523-1528","update-policy":"https:\/\/doi.org\/10.1017\/policypage","source":"Crossref","is-referenced-by-count":1,"title":["Defining the optimal historical control group for a phase 1 trial of mesenchymal stromal cell delivery through cardiopulmonary bypass in neonates and infants"],"prefix":"10.1017","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8815-9029","authenticated-orcid":false,"given":"Kei","family":"Kobayashi","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tessa","family":"Higgins","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mobolanle","family":"Ayodeji","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gil","family":"Wernovsky","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard A.","family":"Jonas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobuyuki","family":"Ishibashi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"56","published-online":{"date-parts":[[2022,8,22]]},"reference":[{"key":"S1047951122002633_ref27","doi-asserted-by":"publisher","DOI":"10.1097\/PCC.0000000000000153"},{"key":"S1047951122002633_ref5","doi-asserted-by":"publisher","DOI":"10.1016\/j.stem.2013.09.006"},{"key":"S1047951122002633_ref11","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccc.2011.04.004"},{"key":"S1047951122002633_ref14","doi-asserted-by":"publisher","DOI":"10.1016\/j.xjon.2021.02.003"},{"key":"S1047951122002633_ref17","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.92.8.2226"},{"key":"S1047951122002633_ref13","doi-asserted-by":"publisher","DOI":"10.1002\/stem.1449"},{"key":"S1047951122002633_ref1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2014-3825"},{"key":"S1047951122002633_ref8","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2002-07-2104"},{"key":"S1047951122002633_ref20","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0000000000001081"},{"key":"S1047951122002633_ref23","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2011.07.003"},{"key":"S1047951122002633_ref21","doi-asserted-by":"publisher","DOI":"10.1177\/2150135117704656"},{"key":"S1047951122002633_ref28","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2011.07.081"},{"key":"S1047951122002633_ref3","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.019881"},{"key":"S1047951122002633_ref19","doi-asserted-by":"publisher","DOI":"10.1097\/00003246-199605000-00004"},{"key":"S1047951122002633_ref25","doi-asserted-by":"publisher","DOI":"10.1053\/j.jvca.2004.10.010"},{"key":"S1047951122002633_ref15","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2019.08.036"},{"key":"S1047951122002633_ref16","doi-asserted-by":"publisher","DOI":"10.1177\/2150135112461924"},{"key":"S1047951122002633_ref30","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCOUTCOMES.117.003533"},{"key":"S1047951122002633_ref31","doi-asserted-by":"publisher","DOI":"10.1017\/S1047951114001450"},{"key":"S1047951122002633_ref6","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.111.000326"},{"key":"S1047951122002633_ref22","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2017.01.050"},{"key":"S1047951122002633_ref29","doi-asserted-by":"publisher","DOI":"10.1017\/S1047951115001031"},{"key":"S1047951122002633_ref2","doi-asserted-by":"publisher","DOI":"10.1097\/PCC.0000000000000800"},{"key":"S1047951122002633_ref10","doi-asserted-by":"publisher","DOI":"10.1038\/pr.2011.61"},{"key":"S1047951122002633_ref26","doi-asserted-by":"publisher","DOI":"10.1097\/PCC.0b013e31816c6f31"},{"key":"S1047951122002633_ref7","doi-asserted-by":"publisher","DOI":"10.1080\/14653240310003611"},{"key":"S1047951122002633_ref24","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2011.03.086"},{"key":"S1047951122002633_ref18","doi-asserted-by":"publisher","DOI":"10.1097\/PCC.0b013e3181b806fc"},{"key":"S1047951122002633_ref9","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2009.06.055"},{"key":"S1047951122002633_ref12","doi-asserted-by":"publisher","DOI":"10.1146\/annurev.med.59.061506.154239"},{"key":"S1047951122002633_ref4","doi-asserted-by":"publisher","DOI":"10.1038\/jcbfm.2013.91"}],"container-title":["Cardiology in the Young"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1047951122002633","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,25]],"date-time":"2023-09-25T07:09:47Z","timestamp":1695625787000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1047951122002633\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,22]]},"references-count":31,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2023,9]]}},"alternative-id":["S1047951122002633"],"URL":"https:\/\/doi.org\/10.1017\/s1047951122002633","relation":{},"ISSN":["1047-9511","1467-1107"],"issn-type":[{"type":"print","value":"1047-9511"},{"type":"electronic","value":"1467-1107"}],"subject":[],"published":{"date-parts":[[2022,8,22]]},"assertion":[{"value":"\u00a9 The Author(s), 2022. Published by Cambridge University Press","name":"copyright","label":"Copyright","group":{"name":"copyright_and_licensing","label":"Copyright and Licensing"}}]}}