Support for Cardiovascular Cell Therapy Research at the National Heart, Lung, and Blood Institute

Heart failure (HF) exerts an enormous burden both in the United States and worldwide, compounded by the lack of effective therapies for patients with end-stage HF. Current options other than medical management are limited to cardiac transplantation, severely limited by the lack of donor availability, and ventricular assist device (VAD) implantation. Although the introduction of newer VADs has reduced complications such as thrombosis and infection, mortality in patients with VADs is still significant (≈25% in the first year1). Since the capacity of the heart to repair itself after myocardial infarction (MI) is very limited, effective regenerative therapies for patients with large acute MI to prevent progression to HF would be highly beneficial in decreasing the morbidity and mortality associated with end-stage HF. Regenerative therapies to repair failing hearts have the potential to provide new options for patients with advanced HF who currently face low quality of life as well as poor prognosis. ### National Heart, Lung, and Blood Institute Cardiovascular Cell Therapy Research Network Clinical trials to test the ability of cell therapy to treat patients after MI were initiated a decade ago in Europe with injection of autologous skeletal myoblasts in patients undergoing coronary artery bypass surgery,2 followed rapidly by trials using other cell types and delivery routes. In response to the proliferation of non-US cell therapy trials, the National Heart, Lung, and Blood Institute (NHLBI) held a working group in August 2004 to assess the status of clinical studies of cell-based therapies for cardiovascular disease, to determine the gaps in knowledge and barriers that prevent the implementation of well-designed and safe clinical studies. Another charge to the working group was to identify the areas of opportunity to apply cell-based therapies for cardiovascular disease.3 The primary recommendation of the working group was the formation of a cardiovascular cell therapy research network, consisting of a clinical research network component …