- 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, nine countries have granted authorization for Cardio3 BioSciences’ Phase III (CHART-1)
Mont-Saint-Guibert, Belgium – Cardio3 BioSciences SA (C3BS) (NYSE Euronext Brussels et NYSE Euronext Paris : CARD), 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 Irish Medicines Board (IMB) to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase III trial for C-Cure® in Ireland.
After the recent authorization in Poland, and earlier in United Kingdom, Belgium, Israel, Serbia, Hungary, Spain and Italy, Ireland is the ninth country to have authorized this unique study, which aims to treat ischemic congestive heart failure.
The CHART-1 trial (Congestive Heart failure Cardiopoietic Regenerative Therapy) represents the world’s first Phase III trial for a pre-programmed cellular therapy for the treatment of heart failure.
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “We are very pleased with the progress of our Phase III clinical study. Adding another European country will enable us to pursue the CHART-1 study according to our objectives.”
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.