23.11.2012 - Belgian Cardio3 BioSciences has received authorisation to begin a European Phase III trial for its autologous stem cell therapy for heart failure.
The Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) Phase III trial will recruit at least 240 patients with chronic advanced symptomatic heart failure, announced the Wallonia-based company on 22 November. The prospective, double-blinded study will compare a treatment with Cardio3’s lead product C3BS-CQR-1 to a sham treatment. 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.
“We believe C3BS-CQR-1 has the potential to become an alternative to heart transplantat, which is the only curative treatment for heart failure available today“, stated Christian Homsy, CEO of Cardio3 BioSciences adding that – to his knowledge – this would be the first Phase III trial ever for a regenerative therapy with this indication. "We look forward to confirming the promising results we have already seen in our Phase II study,” concluded Homsy. Cardio3 tested its treatment in Phase II between 2009 and 2010 in multiple clinical sites in Belgium, Serbia and Switzerland.
The therapy involves taking stem cells from a patient’s own bone marrow and re-programming those cells so that they go on to become heart cells. The cardiopoietic cells, are then injected back into the patient’s heart through a minimally invasive procedure using a catheter with the aim of repairing damaged tissue and improving heart function and patient clinical outcomes.
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