About Ischemic Heart Failure
Heart failure (HF) is a substantial contributor to death and the leading cause of hospitalization in patients over 65 worldwide, causing a significant global health burden. Approximately 2% of the population has HF in developed nations, and this incidence is expected to rise. Additionally, HF has a negative impact on quality of life, and few therapeutic treatment options are available. Due to the rapidly rising incidence of HF and largely ineffective treatments, major advancements in therapies for HF are urgently needed.
C-Cure®: First-in-class reparative cell therapy to treat Heart Failure
Cell and gene therapies hold tremendous promise in the area of HF, and Celyad’s C-Cure® has the potential to be both the most efficacious treatment as well as the first cell therapy in the HF market. Based on innovative cardiopoiesis technology developed at the Mayo Clinic, C-Cure® therapy has been shown to greatly improve outcomes for patients with HF compared with other clinical options. Further enhancing C-Cure®'s efficacy is C-CathezTM, Celyad’s best-in-class cell therapy delivery device.
C-CathezTM improves the efficacy of C-Cure® therapy due to significantly higher retention rates compared with competing catheters and better ease of use.
C-Cure® therapy is well positioned in the HF market as one of the first cell therapies, and the technology is protected by multiple proprietary components. After development at the Mayo Clinic, the C-Cure® technology was exclusively licensed to Celyad for clinical development. Additionally, the breakthrough cardiopoiesis platform is backed by a robust patent portfolio, manufacturing expertise, and internal trade secrets unique to Celyad.
CHART-1: European Phase III clinical trial completed
C-Cure® therapy has undergone testing in one of the first controlled trials of its kind for advanced ischemic HF, CHART-1 (EU Phase III trial). Although the primary endpoint of the randomized trial was not met, a post hoc analysis identified a well-defined subset of patients representing more than 60% of the overall trial population that achieved a clinically meaningful response. Based on the results of CHART-1, a pivotal trial (CHART-2) has been designed to exclusively enroll the key patient subpopulation that will most benefit from C-Cure® therapy. Furthermore, CHART-2 will incorporate better dosing regimens, more stringent medical personnel training, and a new FDA-agreed primary endpoint based on CHART-1 results. Importantly, when the new parameters for CHART-2 are applied to CHART-1, those patients had a statistically significantly improved outcome compared with the controls.
What's next for C-Cure®?
Celyad will use the CHART-1 results as a foundation to optimize the design of the pivotal CHART-2 US trial. In line with this, Celyad is seeking partnerships to accelerate further development and commercialization of C-Cure®. For more information, please go to our partnering section.
To discover all our publications in cardiology, please go to our Library section and select "Cardiology Publications".
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