Intramyocardial cell-based therapy with Lomecel-B during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: the ELPIS phase I trial
Kaushal S, Hare J, Hoffman J, Boyd R, Ramdas K, Pietris N, Kutty S, Tweddell J, Husain S, Menon S, Lambert L, Danford D, Kligerman S, Hibino N, Korutla L, Vallabhajosyula P, Campbell M, Khan A, Naioti E, Yousefi K, Mehranfard D, McClain-Moss L, Oliva A, Davis M. Intramyocardial cell-based therapy with Lomecel-B during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: the ELPIS phase I trial. European Heart Journal Open 2023, 3: oead002. PMID: 36950450, PMCID: PMC10026620, DOI: 10.1093/ehjopen/oead002.Peer-Reviewed Original ResearchCardiac magnetic resonance imagingGlobal longitudinal strainMedicinal signaling cellsEjection fractionRight ventricleOpen-label multicentre trialMajor adverse cardiac eventsHypoplastic left heart syndromeAdverse cardiac eventsInvestigational cell therapyBidirectional cavopulmonary anastomosisPhase I trialRV ejection fractionRisk of deathMagnetic resonance imagingPrimary endpointCardiac eventsRV functionSurgical palliationI trialMulticentre trialCavopulmonary anastomosisCell-based therapiesHeart syndromeRibonucleic acid