CQR 1 stem cell (Cardio3Biosciences) to begin Phase III Heart Failure trial
The Italian Medicines Agency has given approval to begin the CHART-1 European Phase III trial for CQR 1 (formerly C-Cure), from Cardio3Biosciences, in Italy. The CHART-1 trial represents the world's first Phase III trial for a pre-programmed cellular therapy targeting Heart Failure. 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.
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