A French start-up has designed and developed an automated device to culture heart stem cells. This might be an alternative to a heart transplant for 1 million patients in the main Western countries.
Bernard Banga and Nathalie Gnory MD Report, France
It’s a simple idea: making heart tissue from patients’ own cells to repair heart damage caused by acute myocardial infarction. But it took Professor Philippe Hénon, chairman/CSO and co-founder of CellProthera, and president of the Haematology and Transplant Research Institute in Mulhouse, around ten years to bring it to completion.
His start-up based in Mulhouse (Haut-Rhin, France), which pioneers cardiac regeneration therapy, has developed treatment that could provide a real alternative to heart transplants. The technology involves selecting, collecting, purifying and multiplying stem cells from patient blood samples and then directly re-injecting a cell graft into their damaged heart area. Opening up the thorax to carry out heart transplants or bypass operations might no longer be necessary. Consequently, the overall cardiac grafting process has become a straightforward interventional cardiology treatment equivalent to inserting a coronary stent.
The technology enables heart tissue necrosed by acute myocardial infarction to regenerate within a few months. Cardiac regeneration therapy is expected to significantly reduce the cost of treating the 1 million congestive heart patients recorded annually throughout the main Western countries.
The cell grafts are produced by a patented, automated device enabling mass production of the autologous grafts needed for heart tissue regeneration and myocardial revascularization. This automated device comprises culture medium reservoirs, an incubator with a thermostatic chamber containing the cell culture vessel, and a control system to agitate and support the culture vessel. The cell expansion bag walls have special properties that reduce adhesion by culture cells. This so-called StemXpand device also has a peristaltic pump controlling the supply of culture medium to the cell expansion bag and reservoirs of growth factors and culture cells. “Using a simple patient blood sample, several million CD34+ blood stem cells are isolated and cultured in our automated device and associated production kit,” explains Jean-Claude Jelsch, CellProthera’s CEO. These cells are multiplied up to twentyfold and then re-injected into patients via an intra-arterial catheter extending as far as the infarction-induced myocardial injury. This regenerates its anatomy and functioning. Nine days are required to produce these stem cells.
Half-a-dozen prototypes of this automated device are operational in France and UK. After biological validation of its automated devices, CellProthera is getting ready for an international phase II clinical trial on 44 patients at five clinical centres in France and three in the UK. The first equipment, automated devices and single-use kits are due to be marketed in 2017. The world cardiac insufficiency market is worth an estimated 50 billion euros. CellProthera hopes to win a 15% market share within the next five years.
Posted in Biotechnology by Thomas Klein on December 12, 2014