Industrialized GMP Production of CD34+ Cells (ProtheraCytes®) at Clinical Scale for Treatment of Ischemic Cardiac Diseases Is Feasible and Safe
Philippe Hénon, Marc Kowalczyk, Anne Aries, Christine Vignon, G. Trébuchet, Rachid Lahlil
Abstract
Abstract Regenerative medicine now needs to pass a crucial turning point, from academic research to the market. Several sources/types of cells have been experimented with, more or less successfully. CD34 + cells have demonstrated multipotent or even pluripotent capacities, making them good candidates for regenerative medicine, particularly for treating heart diseases. Strongly encouraged by the results we achieved in a pilot study using CD34 + stem cells in patients with poor-prognosis acute myocardial infarcts (AMIs), we soon began the development of an industrialized platform making use of a closed automated device (StemXpand ® ) and a disposable kit (StemPack ® ) for the large-scale expansion of CD34 + cells with reproducible good manufacturing practice (GMP). This scalable platform can produce expanded CD34 + cells (ProtheraCytes ® ) of sufficient quality that, interestingly, express early markers of the cardiac and endothelial pathways and early cardiac-mesoderm markers. They also contain CD34 + pluripotent cells characterized as very small embryonic-like stem cells (VSELs), capable of differentiating under appropriate stimuli into different tissue lineages, including endothelial and cardiomyocytic ones.