iBET

iBET on the National TV news: An innovative clinical trial and the first in Europe with stem cell infusion for cardiac regeneration

12.06.2017

 

  • This is the first European cell therapy clinical trial with infusion of human cardiac stem cells.
  • Cardiac stem cells are a small population of cells residing in the heart, with regenerative effects already scientifically proven by several laboratories.
  • Regeneration of the myocardium (cardiac muscle) through cell therapy can save the lives of millions of people with cardiovascular diseases which, according to the World Health Organization, accounts for 31% of all deaths in the planet (17.5 million in 2012).
  • At the end of a year following the patients in this phase I / II clinical trial, the results demonstrate that the safety objectives (Phase 1) of stem cell infusion in the heart were achieved - absence of mortality, of immune rejection and of adverse cardiac effects - main focus of this essay.
  • A reduction of the infarct area was also observed in a specific subgroup of patients, those with the worst prognosis and corresponding to more than half of the patients involved in the clinical trial.

The consortium integrating iBET released the results of the first year of this is the first European clinical trial using human heart stem cells for the treatment of patients with acute myocardial infarction. The clinical trial in Spain and Belgium is innovative, marking the final stretch of the European research project CARE-MI - CArdio Repair European Multidisciplinary Initiative.

"It was with great enthusiasm that we received today the first clinical results of patients injected with cardiac stem cells in the CARE-MI clinical trial. These 12-month follow-up results may help understand the true potential of this cellular therapy among thousands of people suffering from myocardial infarction and heart failure, two of the leading causes of death in developed countries, "said Patrícia Alves, researcher of iBET at CARE-MI.

After infusion with the cardiac stem cells, the 55 patients who are involved in the clinical trial have been followed up during this past year. The results now reported are extremely promising as no adverse effects or rejection has been observed in the patients.

The main focus of this Phase I / II trial was on the safety and viability of this type of cells, however, it was also possible to observe a very significant regeneration of the cardiac muscle in the subgroup of higher risk (worse prognosis) patients. These results pave the way for a more targeted study and follow-up of these patients and reinforce the expectation that human cardiac stem cell therapy may become an innovative and more effective therapy for this type of cardiac patients.

"These clinical outcomes not only opens the doors to further studies in more specific patient groups, but also reinforces our expectations that this therapy meets the conditions necessary to advance to market because it is economically and logistically feasible, widely available for application and will also be compatible with current standards of clinical treatment and, therefore, easy to apply, " stressed Paula Alves, CEO of iBET and Principal Investigator of the project.