- CHART-1 trial represents the world’s first Phase III trial in regenerative medicine for a pre-programmed cellular therapy targeting heart failure
- To date, seven countries have granted authorization for Cardio3 BioSciences’ Phase III (CHART-1)
- Six leading clinical centers will participate in CHART-1 in Italy
Mont-Saint-Guibert, Belgium – The Belgian biotechnology company, Cardio3 BioSciences (C3BS), a leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, today announces it has received authorization from the Italian Medicines Agency (AIFA) to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C-Cure® in Italy.
After the recent authorization in Spain, and earlier in United Kingdom, Belgium, Israel, Serbia and Hungary, Italy is the seventh country to have authorized this unique study. There will be six leading clinical centers participating to the trial in Italy.
The CHART-1 trial represents the world’s first Phase III trial for a pre-programmed cellular therapy targeting heart failure.
Professor Marco Metra, the Principal Investigator in Italy commented: “We are proud to participate in this Phase III trial evaluating the benefit of C-Cure® cardiopoietic cells for the treatment of severe heart failure. We believe that the CHART-1 study is one of the most important current studies on improving the treatment of chronic heart failure. We hope that this innovative treatment will improve the quality of life of patients suffering from this progressive and debilitating disease, one of the most important unmet medical needs today. E’ tempo d’iniziare! Anche nel nostro paese! ”
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We are very pleased with the progress of our Phase III clinical study. Adding another big European country like Italy, which will open six sites, will enable us to pursue the study according to our development plan.”
The Phase III trial is a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C-Cure® to a sham treatment. The trial will recruit a minimum of 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at 9 months post-procedure.