The study is published in the journal of JACC: Basic to Translational Science.
Vanderbilt University researchers have examined the safety and efficacy of a single infusion of Cimaglermin, which acts as a growth factor for the heart, helping the structural, metabolic and contractile elements of the heart to repair itself following injury.
The study enrolled 40 heart failure patients who were taking optimal medical therapy for at least three months prior to the trial. The patients who received a high dose of cimaglermin had a sustained increase in left ventricular ejection fraction, or pumping capacity, through 90 days after dosing, with the maximum increase reached at Day 28. These findings support continued clinical development of the investigational drug cimaglermin, including further safety evaluations and detailing the potential improvement on clinical heart failure outcome measures,” said lead study author Daniel J Lenihan.
“As with all experimental therapeutics, additional studies will be required and subject to regulatory review to determine if the relative risks and benefits of cimaglermin warrant approval,” Lenihan added.
Limitations of this study include the small sample size and the fact that patients only received a single infusion rather than multiple doses. “Although the results of the study must be regarded as provisional because of the small numbers of patients, the results of this study are nonetheless very exciting,” said another author Douglas L Mann.
“If the results of this study can be replicated and translated into improvements in clinical outcomes in larger numbers of patients in phase II and III clinical trials, it will represent a paradigm shift in the way in which clinicians treat patients with heart failure,” he explained.