Cardio3 BioSciences has announced it has received authorisation from the Italian Medicines Agency (AIFA) to begin its CHART-1 (Congestive heart failure cardiopoietic regenerative therapy) European phase III trial for C-Cure in Italy.
The CHART-1 trial, according to a company release, represents the world’s first phase III trial in regenerative medicine for a pre-programmed cellular therapy targeting heart failure.
After the recent authorisation in Spain, and earlier in United Kingdom, Belgium, Israel, Serbia and Hungary, Italy is the seventh country to have authorised this study. There will be six centres participating in the trial in Italy.
“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,” said Marco Metra, principal investigator in Italy.
The phase III trial is a prospective, multicentre, randomised, 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 nine months post-procedure.