{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T13:13:05Z","timestamp":1789737185074,"version":"4.0.1"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2015,1,5]],"date-time":"2015-01-05T00:00:00Z","timestamp":1420416000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2015,2,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title\/>\n                  <jats:p>Congenital heart diseases (CHDs) requiring surgical palliation mandate new treatment strategies to optimize long-term outcomes. Despite the mounting evidence of cardiac regeneration, there are no long-term safety studies of autologous cell-based transplantation in the pediatric setting. We aimed to establish a porcine pipeline to evaluate the feasibility and long-term safety of autologous umbilical cord blood mononuclear cells (UCB-MNCs) transplanted into the right ventricle (RV) of juvenile porcine hearts. Piglets were born by caesarean section to enable UCB collection. Upon meeting release criteria, 12 animals were randomized in a double-blinded fashion prior to surgical delivery of test article (n = 6) or placebo (n = 6). The UCB-MNC (3 \u00d7 106 cells per kilogram) or control (dimethyl sulfoxide, 10%) products were injected intramyocardially into the RV under direct visualization. The cohorts were monitored for 3 months after product delivery with assessments of cardiac performance, rhythm, and serial cardiac biochemical markers, followed by terminal necropsy. No mortalities were associated with intramyocardial delivery of UCB-MNCs or placebo. Two animals from the placebo group developed local skin infection after surgery that responded to antibiotic treatment. Electrophysiological assessments revealed no arrhythmias in either group throughout the 3-month study. Two animals in the cell-therapy group had transient, subclinical dysrhythmia in the perioperative period, likely because of an exaggerated response to anesthesia. Overall, this study demonstrated that autologous UCB-MNCs can be safely collected and surgically delivered in a pediatric setting. The safety profile establishes the foundation for cell-based therapy directed at the RV of juvenile hearts and aims to accelerate cell-based therapies toward clinical trials for CHD.<\/jats:p>\n               <\/jats:sec>","DOI":"10.5966\/sctm.2014-0195","type":"journal-article","created":{"date-parts":[[2015,1,5]],"date-time":"2015-01-05T22:40:01Z","timestamp":1420497601000},"page":"195-206","source":"Crossref","is-referenced-by-count":26,"title":["Safety and Feasibility for Pediatric Cardiac Regeneration Using Epicardial Delivery of Autologous Umbilical Cord Blood-Derived Mononuclear Cells Established in a Porcine Model System"],"prefix":"10.1093","volume":"4","author":[{"given":"Susana","family":"Cantero Peral","sequence":"first","affiliation":[{"name":"Division of General Internal Medicine, Rochester, Minnesota, USA"},{"name":"Center for Regenerative Medicine, Rochester, Minnesota, USA"},{"name":"Program of Doctorate of Internal Medicine, Autonomous University of Barcelona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harold M.","family":"Burkhart","sequence":"additional","affiliation":[{"name":"Pediatric Cardiothoracic Surgery, Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saji","family":"Oommen","sequence":"additional","affiliation":[{"name":"Division of General Internal Medicine, Rochester, Minnesota, USA"},{"name":"Center for Regenerative Medicine, Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satsuki","family":"Yamada","sequence":"additional","affiliation":[{"name":"Center for Regenerative Medicine, Rochester, Minnesota, USA"},{"name":"Division of Cardiovascular Diseases, Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott L.","family":"Nyberg","sequence":"additional","affiliation":[{"name":"Center for Regenerative Medicine, Rochester, Minnesota, USA"},{"name":"Transplant Center, Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xing","family":"Li","sequence":"additional","affiliation":[{"name":"Division of Biomedical Statistics and Informatics, Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick W.","family":"O'Leary","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Diseases, Rochester, Minnesota, USA"},{"name":"Division of Pediatric Cardiology, Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andre","family":"Terzic","sequence":"additional","affiliation":[{"name":"Center for Regenerative Medicine, Rochester, Minnesota, USA"},{"name":"Division of Cardiovascular Diseases, Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bryan C.","family":"Cannon","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology, Rochester, Minnesota, 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