Cardio3 BioSciences has announced the enrolment of the 240th patient in its CHART-1 European trial for C-Cure, the first and only stem cell therapeutic using guided stem cells for the treatment of congestive heart failure.
With recruitment that started in mid-2013, Cardio3 BioSciences has enrolled 240 patients in less than 18 months, ahead of schedule. As usual in clinical trials targeting severe indications, the company will continue to recruit additional patients in anticipation of patient dropouts. The CHART-1 trial is currently ongoing in 12 countries in Europe and Israel.
The CHART-1 (Congestive heart failure cardiopoietic regenerative therapy) trial represents the world’s first phase III trial for a pre-programmed cellular therapy for the treatment of heart failure.
Christian Homsy, chief executive officer of Cardio3 BioSciences, says: “We are extremely pleased to have enrolled the 240th patient of CHART-1, ahead of schedule. This represents a major achievement for the entire team involved in this trial and I am proud we succeeded in achieving this key operational objective this year. The CHART-1 trial remains solidly on track, with the interim futility readout scheduled for the end of March 2015 and the readout of the full dataset a year later. This accomplishment demonstrates our clinical expertise and gives us confidence for the upcoming CHART-2 trial, to be initiated soon in the USA.”
CHART-1 is the company’s first phase III clinical trial, intended to assess in Europe, the efficacy of C-Cure as a treatment for heart failure of ischaemic origin. The CHART-1 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 requires the recruitment of 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. The CHART-1 trial is currently ongoing in 11 countries in Europe (Sweden, Ireland, the United Kingdom, Belgium, Serbia, Bulgaria, Hungary, Spain, Italy, Poland, Switzerland) and Israel.