Autologous cell therapy for enhanced endovascular repair after coronary stent implantation

A little history Michael Kutryk is the name of the interventional cardiologist and scientist who had this dream. As early as the late 90s, Michael had the vision that it could be most desirable to heal strut coverage specifically with functional endothelial cells in order to improve the biocompatibility of metallic stents. The concept of designing a “prohealing” device with accelerated restoration of endothelial continuity was born at least at first in the mind of its inventor, but was quickly supported by bench and preclinical experiments. By this time, Kutryk had left Canada to join the group at the Thoraxcenter in Rotterdam as a post-doctoral fellow (Figure 1). During this period, Patrick Serruys was experimenting with local drug delivery with sweating balloons and, needless to say, he was immediately taken with Kutryk’s idea. Perhaps somewhat naively, they hypothesised that endothelial progenitor cell capture could prevent at one and the same time both thrombosis and restenosis. It should be remembered that in those early days of stenting, the issues were immediate stent thrombosis and early restenosis, at rates of 20% each! Nobody at that time was anticipating that late thrombotic events would plague the future anti-restenosis solutions, initially vascular brachytherapy and now drug-elution. The Genous technology invented by Kutryk and embraced by Serruys was developed and supported by Orbus Medical Technologies, and later acquired by Neich, an Asian-based company to form Orbus-Neich. Major research and development efforts eventually led to the First-In-Man trial that was published in 2005. The illustration (Figure 2) depicting the principles of the therapy was indeed very convincing, to the point that it was eventually included in the patient informed consent document for further studies. It shows how the stent is covered with a biocompatible matrix to which murine, monoclonal, anti-human CD34+ antibodies are covalently attached. The antibody is specific to the surface antigens, present on circulating endothelial progenitor cells creating an immuno-affinity surface for preferentially capturing these circulating cells. CE mark approval was obtained on August 11, 2005. The HEALING clinical trial program was designed and indeed completed, and publications appeared at an increasing pace. The device also underwent a number of technical iterations including the use of a cobaltchromium stent platform, to replace the bio-engineered R-stent.

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