Development of a potency assay for CD34⁺ cell-based therapy.

ABSTRACT: We have previously shown that intracardiac delivery of autologous CD34⁺ cells after acute myocardial infarction (AMI) is safe and leads to long term improvement. We are now conducting a multicenter, randomized, controlled Phase I/IIb study in post-AMI to investigate the safety and efficacy of intramyocardial injection of expanded autologous CD34⁺ cells (ProtheraCytes) (NCT02669810). Here, we conducted a series of in vitro studies characterizing the growth factor secretion, exosome secretion, gene expression, cell surface markers, differentiation potential, and angiogenic potential of ProtheraCytes clinical batches to develop a potency assay. We show that ProtheraCytes secrete vascular endothelial growth factor (VEGF) and its concentration is significantly correlated w

SUBMITTER: Aries A 

PROVIDER: S-EPMC10640600 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature