Industrialized GMP Production of CD34+ Cells (ProtheraCytes®) at Clinical Scale for Treatment of Ischemic Cardiac Diseases Is Feasible and Safe

Stem Cell Rev Rep. 2022 Jun;18(5):1614-1626. doi: 10.1007/s12015-022-10373-5. Epub 2022 Apr 14.

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.

Keywords: CD34+ cells; Cell expansion; Heart diseases; Industrialization; ProtheraCytes®; Regenerative medicine; VSELs.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antigens, CD34 / metabolism
  • Embryonic Stem Cells / metabolism
  • Humans
  • Myocardial Infarction* / therapy
  • Myocardial Ischemia*
  • Pilot Projects
  • Regenerative Medicine / methods

Substances

  • Antigens, CD34