TiGenix announces success of novel heart attack stem cell trial
Belgium’s TiGenix has announced the success of its top-line Phase 2/3 study investigating the effects of donor-derived expanded cardiac stem cells (AlloCSCs) in the treatment of acute myocardial infarction (AMI), the first trial to utilise a selective magnetic resonance imaging (MRI) strategy to identify candidates with increased risk of heart failure and late adverse outcomes.
“This is the first study in which we have used a state of the art comprehensive MRI analysis to include patients with a large myocardial infarction in an innovative cell therapy protocol,” explained Professor Janssens, Principal Trial Investigator in Belgium and Head of the Department of Cardiovascular Diseases at University Hospital in Leuven. “Serial MRI analysis and extensive immunological profiling will allow us to further explore the encouraging signals we observed in cell treated patients with the worst MRI signature.”
The trial was designed to evaluate the safety and feasibility of treating those suffering from AMI with an intracoronary infusion of 35 million of AlloCSCs. TiGenix announced that the trial met all safety objectives, with patients surviving while experiencing no major cardiac adverse events for 30 days, as well as after six and twelve month follow-ups.
Additionally, a larger reduction in infarction size and tissue death was observed in those with poor long-term outlook, due to inadequate blood supply.
“This is the first trial in which it has been demonstrated that allogeneic cardiac stem cells can be transplanted safely through the coronary tree, and in the worst possible setting represented by patients with an acute heart attack with left ventricular dysfunction,” commented Professor Fernández-Avilés, Principal Investigator in Spain and Head of the Department of Cardiology at the Hospital General Universitario Gregorio Marañón in Madrid. “It is especially encouraging that no cardiac or immunological side effects were observed.”
Dr Marie Paule Richard, Chief Medical Officer at TiGenix, added: “Besides confirming the long term safety of the treatment these results suggest interesting opportunities in populations with high unmet medical need. We look forward to working with our advisors to analyse the data in depth and determine the best way forward with AlloCSC-01 during the second half of this year.”
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