Cardio3 BioSciences (C3BS) has obtained authorisation from the Belgian Federal Agency for Medicines and Health Products to commence its C3BS-CQR-1 Phase III heart failure trial in Belgium.
The prospective, multi-centre trial will enrol around 240 chronic advanced symptomatic heart failure patients and compare C3BS-CQR-1 treatment with sham treatment.
C3BS-CQR-1 therapy uses the proprietary Cardiopoiesis procedure, which involves taking self stem cells from patient’s bone marrow and reprogramming them to cardiopoietic cells.
The cardiopoietic cells are then injected into the diseased heart using a special catheter to repair and regain the lost heart function.
Cardio3 BioSciences CEO Dr Christian Homsy said heart failure is linked to high morbidity, mortality and escalating healthcare costs.
"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," Homsy said.
"Our Phase III trial is the first to begin anywhere in the world for a regenerative therapy for this indication. We look forward to confirming the promising results we have already seen in our Phase II study."
The randomised, patient and evaluator-blinded study’s primary endpoint is a composite endpoint of mortality, morbidity, quality of life, six minute walk test and left ventricular structure in addition to heart functioning nine months after the procedure.
Upon the issuance of national regulatory approvals in various countries, other studies are expected to commence, according to the company.
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."