Multi-centre, randomized trial designed to compare C3BS-CQR-1 treatment with sham treatment is expected to enroll at least 240 patients suffering from chronic advanced symptomatic heart failure.
The composite endpoint of mortality, morbidity, quality of life, six minute walk test and left ventricular structure besides heart function at nine months after procedure is the primary endpoint of the patient-and evaluator-blinded study.
C3BS CEO Dr Christian Homsy said, "We believe C3BS-CQR-1 has a potential to become an alternative to heart transplantation which is the only curative treatment for heart failure available today."
The heart failure therapy involves a Cardiopoiesis process of collecting stem cells from a patient’s self bone marrow and re-progamming them to heart cells or cardiopoietic cells.
A C-Cathez catheter will be used to inject the cardiopoietic cells into the patient’s damaged heart using a modestly invasive procedure, so as to repair the injured tissue and recover heart function.
Principal investigator Dr Jozef Bartunek said, "The results seen in the earlier trials were encouraging and if repeated in this larger study would bring nearer a potentially disruptive treatment for the expanding epidemic of heart failure."