Intramyocardial cell-based therapy with Lomecel-B during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: the ELPIS phase I trial.
Sunjay KaushalJoshua M HareJessica R HoffmanRiley M BoydKevin N RamdasNicholas PietrisShelby KuttyJames S TweddellS Adil HusainShaji C MenonLinda M LambertDavid A DanfordSeth J KligermanNarutoshi HibinoLaxminarayana KorutlaPrashanth VallabhajosyulaMichael J CampbellAisha KhanEric NaiotiKeyvan YousefiDanial MehranfardLisa McClain-MossAnthony A OlivaMichael E DavisPublished in: European heart journal open (2023)
Intramyocardially delivered Lomecel-B appears safe in HLHS patients and may favourably affect RV performance. Circulating exosomes of transplanted MSC-specific provide novel insight into bioactivity. Conduct of a controlled phase trial is warranted and is underway.Trial registration number NCT03525418.
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