Detroit-based Henry Ford Health System is studying an investigational cell therapy called CardiAMP in a Phase III clinical trial for patients who have previously suffered a heart attack and subsequently developed heart failure. The therapy uses stem cells to treat heart failure.
In heart failure, the heart continues to pump blood. However, it cannot pump enough blood and oxygen to support other organs in the body.
According to the Centers for Disease Control and Prevention, about 6.2 million adults in the U.S. have heart failure. It is the cause of an estimated one in eight deaths in the U.S., and each year, there are about 960,000 new cases diagnosed across the country, according to the American Heart Association.
The CardiAMP cell therapy clinical trial delivers the patient’s own stem cells directly into the heart, with the goal of triggering the body’s natural healing process and helping to restore the strength of the heart muscle. Current treatments for heart failure include lifestyle changes, medications, and certain devices or surgical procedures.
“In this clinical trial, we are studying what could be a new horizon in the world of heart failure treatment,” says Dr. Gerald Koenig, cardiologist and principal investigator of the CardiAMP clinical trial at Henry Ford. “While the results of this particular study are not yet known, previously published studies of this type of cell therapy have shown meaningful and sustained improvements in quality of life and heart function for patients.”
The cell therapy is designed for patients who have heart failure and feel tired and breathless despite taking regular medications, and who have had to limit their everyday activities as a result.
Initially, patients in the trial undergo a bone marrow biopsy. The cells are tested to determine if they have characteristics that may result in a higher likelihood of the patient benefiting from the therapy.
For those who qualify, doctors will extract cells from a patient’s bone marrow, process them at the point of care, and deliver them to the damaged area of the heart in a minimally invasive cardiac catheterization procedure. The bone marrow cells do not turn into new heart tissue cells, but they are designed to stimulate the body’s natural healing process in the heart.
More information on the trial, which is underway, is available here.