Starting with the earliest efforts to produce stem cell therapies, repairing damage and dysfunction of the heart has always been a primary goal. At present only very partial repair is possible in human cell therapies, for reasons that include the fact that cell therapies cannot address the buildup of important metabolic wastes such as cross-links, but improvement towards more optimal outcomes in this class of therapy is an incremental process of finding and refining methodologies of production and delivery of cells. With this in mind, researchers have recently achieved a very promising result in an animal study:
A new study shows that weeks after infusions of cardiosphere-derived cells (CDCs), the heart-pumping function returned to normal in laboratory rats with hypertension and diastolic heart failure. Formerly known as diastolic heart failure, the diagnosis now called heart failure with preserved ejection fraction is a condition in which the heart muscle becomes so stiff that its pumping chambers cannot properly fill with blood. Even though the heart's ability to pump blood to the body remains normal, its inability to fill with blood over time can lead to fluid buildup. This affects other body organs and causes fluid congestion, especially in the lungs. The hard-to-treat condition leads to extreme fatigue and difficulty breathing.
In the new research study, 34 laboratory rats with hypertension and heart failure with preserved ejection fraction were given infusions of cardiac stem cells. A second group of 34 laboratory rats were given a placebo. Four weeks later, the rats in the stem cells group had normalized heart function and their hearts were able to fill normally. Those in the placebo group became progressively sicker and died prematurely. "When patients with preserved ejection fraction get sick, they might be hospitalized and they might be prescribed medications like diuretics, which reduce the buildup of fluid in the lungs. The patients might get better symptomatically, but we haven't really treated the underlying condition. This research suggests that cardiac stem cells could be effective as a therapeutic agent, and there is a specific treatment we can try when everything else has failed." On the basis of these findings, the researchers have recently obtained clearance from the FDA to use cardiospheres to treat humans with heart failure with preserved ejection fraction. These stem cells, manufactured by Capricor as their product CAP-1002, have already been used in other human clinical trials.