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Cardio3 BioSciences Completes Patient Enrolment in First Stage of Pivotal Trial of C-Cure(R) in Heart Failure
Date:12/15/2009

MONT-SAINT-GUIBERT, Belgium, December 15 /PRNewswire/ --

- 45 Patients Enrolled in Study Designed to Evaluate the Ability of Cardiopoietic Cells to Restore Cardiac Function

Cardio3 BioSciences, a leading Belgian biotechnology company specialising in cell-based therapies for the treatment of cardiovascular diseases, announced today that it has completed, two months ahead of schedule, enrolment in the first stage of its pivotal Phase II/III trial of C-Cure, a unique stem cell therapy for heart failure. Forty-five patients have now enrolled in the study which is being conducted at centres in Belgium and Serbia. The C-Cure trial will ultimately enroll 240 patients making it one of the largest randomized trials in regenerative therapies for heart failure.

C-Cure is produced by taking a patient's own bone marrow cells and, through a proprietary process, differentiating them into cardiopoietic cells that can regenerate damaged heart muscle. The cardiopoietic cells are injected into the heart of a patient with heart failure where they are designed to behave identically to those cells lost in heart failure without carrying the risk of rejection, something that has not been achieved with previous cell therapies for this indication. C-Cure is the outcome of multiple years of research conducted at Mayo Clinic (Rochester, Minnesota, USA) and at the Cardiovascular Center in Aalst (Aalst, Belgium).

Safety data from this stage of the trial is expected to be available in May 2010. The second stage, which will recruit 195 further patients is expected to start in the third quarter of 2010 and involve further sites in Europe and in the United States. The trial design is a randomized, prospective, multi-center trial, to evaluate the safety and efficacy of C-Cure beyond optimal clinical care in patients with heart failure. The trial will also evaluate socio-economic implications of the
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SOURCE Cardio3 BioSciences
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