Cardio3BioSciences (C3BS) has announced that the C-CURE study has been published in the Journal of the American College of Cardiology. The study indicates that cardiopoietic stem cell therapy is associated with statistically significant improvements in heart function and exercise tolerance in patients with chronic heart failure.
The C-Cure trial was a prospective, multicentre, randomised study to evaluate the feasibility, safety, and efficacy of CQR-1 in the treatment of patients with chronic heart failure secondary to ischemic cardiomyopathy.
A company press release reported that CQR-1 consists of the patient’s own stem cells harvested from the bone marrow and engineered to become progenitors of new functional cardiac cells. Those cells behave identically to the cells lost to heart disease. In the C-Cure trial, all patients received optimal standard-of-care for heart failure, while treated group also received an intra-myocardial injection of CQR-1.
According to the press release, the study showed that stem cell therapy was associated with statistically significant improvement in cardiac function and statistically significant improvement in six-minute walk distance for the treated patients. It added that the publication concluded that the therapy with C3BS-CQR-1 (previously C-Cure) was feasible and safe with signals of benefit in chronic heart failure, meriting further definitive clinical evaluation.
On the basis of these outcomes, the press release noted, C3BS has initiated a Phase III trial for CQR-1, called CHART-1 for Congestive Heart failure Cardiopoietic Regenerative Therapy. This is the first Phase III trial using organ specified cells for the treatment of ischaemic heart failure and will recruit approximately 240 patients, with chronic advanced symptomatic heart failure. The primary endpoint of the trial integrates cardiac and clinical endpoints as recommended by the European Medicines Agency.
Jozef Bartunek, principal investigator, said: “The Phase II trial demonstrates that cardiopoietic stem cell therapy is feasible, safe and with strong signals of efficacy. These results highlight the promise of such novel technology for optimized regenerative intervention in heart failure, bringing next generation therapies to patients. With Cardio3 BioSciences having started the follow-up Phase III trial, the cardiopoietic approach is at the forefront of this exciting field.”