Date: 2013-04-11
Type of information: Publication of results in a medical journal
phase: 2
Announcement: publication of results in the on - line edition of the Journal of the American College of Cardiology (JACC)
Company: Celyad previously known as Cardio3 Biosciences (Belgium)
Product: C3BS-CQR-1 (C-Cure®)
Action
mechanism: stem cell therapy. C3BS-CQR-1 (C-Cure®) is a stem cell therapy for heart failure.This novel stem cell therapy involves taking a patient’s own bone marrow stem cells and guides them to repair heart tissue when introduced into a damaged heart area. This newest innovation builds on a proprietary “cardiopoietic platform”, and the ongoing collaborations with investigators at Mayo Clinic and Aalst Cardiovascular Center.
Disease: heart failure
Therapeutic area: Cardiovascular diseases
Country: Belgium, Serbia
Trial details:
Latest
news: * On April 11, 2013, Cardio3 BioSciences (C3BS) has announced the advanced publication of C-CURE (Phase II) trial results in the on-line edition of the Journal of the American College of Cardiology (JACC).
The publication reported:
•Statistically significant improvement in cardiac function for the treated patients,
• Statistically significant improvement in 6-minute walk distance for the treated patients.
Thepublication 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.
The C-Cure trial was a prospective, multicenter, randomized study to evaluate the feasibility, safety, and efficacy of CQR-1 in the treatment of patients with chronic heart failure secondary to ischemic cardiomyopathy.
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. On the basis of these outcomes, 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 ischemic 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 .
* On May 18, 2011, Cardio3 BioSciences has presented Phase II clinical trial data of the flagship product C3BS-CQR-1 (C-Cure®), at the EuroPCR Meeting in Paris. This is the First-in-man use of lineage specified stem cells for the treatment of heart failure. The trial demonstrates that heart failure patients improved heart function and exercise capacity at 6 months following treatment of C-Cure, an innovative stem cell therapy based on the Company’s “Cardiopoiesis” proprietary technology. Moreover, feasibility and safety of the C-Cure treatment regimen were established.
* On April 5, 2011, Cardio3 BioSciences has revealed detailed data from the Phase II clinical trial of its novel stem cell therapy for heart failure, C3BS-CQR-1 (C-Cure®), at the 60th annual American College of Cardiology in New Orleans, USA.The clinical study was presented by Dr. Jozef Bartunek, Associate Director of the Cardiovascular Center in Aalst, Belgium and Co-Principal Investigator of the C-Cure trial. The results show that, beyond existing best standard of care, patients saw improvements in heart function and exercise capacity when treated with C-Cure. This novel stem cell therapy involves taking a patient’s own bone marrow stem cells and guides them to repair heart tissue when introduced into a damaged heart area.
The Phase II trial recruited 45 patients with severe heart failure of ischemic origin in Belgium and Serbia who were treated with optimal standard of care (Control group) or optimal standard of care plus C-Cure (C-Cure group). Patients receiving C-Cure saw an 18.1% increase in left ventricular ejection fraction (LVEF), a measure of heart function, over baseline, as measured by echocardiography, while the mean LVEF improved only marginally in patients enrolled in the control group. This difference in LVEF between the C-Cure treated and control patients was significant (p<0.01) suggesting that C-Cure treatment leads to heart tissue repair.
Importantly, signs of functional heart improvement were supported by improved fitness, shown by a clinically meaningful mean difference in the 6-minute walking distance test between the C-Cure treatment and control groups. After 6 months, patients treated with C-Cure were able to walk an average of 52 metres further in six minutes whereas control patients treated with current optimal standard of care were able to walk 21 metres less on average. The difference of 73 meters between both groups suggests heart failure patients treated with C-Cure could expect to return to a more active lifestyle, as they recover their ability to perform daily activities. The company is currently planning the next stages of product development.
