A new Phase II clinical trial, published in The Lancet, is bringing new hope to victims of this heart disease.
Using patients’ own stem cells from bone marrow, researchers sought to discover whether a therapy procedure could improve the quality of life for patients with heart failure. What they found was even more revealing.
Stem cells could be a treatment option for heart failure.
According to the study, of the 126 patients involved, those who received stem cell treatment injections to their heart had their chances of dying due to heart failure or heart-related events decrease by 37 percent.
Further, of the 51 patients in the placebo group, 75 percent dealt with serious health problems compared to 53 percent of patients who received stem cell treatments.
To conduct the study, researchers gathered patients from 31 different areas across North America. For patients to take part in the research, they needed to:
- Have a left ventricular ejection fraction of 35 percent or less, which is well below the normal 50 to 70 percent ejection fraction. The American Heart Association points out that the ejection fraction is how much blood the left portion of a person’s heart pumps per beat.
- Own an automatic implantable cardioverter defibrillator, which is a device that measures a person’s heart rate. These devices can prevent patients who suffer from ventricular tachycardia from dying by providing a slight electrical shock to the heart during an emergency.
- Be classified as a class III or IV heart failure patient based on the New York Heart Association scale of heart failures. The NYHA categorizes patients as either I through IV depending on how much they’re limited in performing physical activities. Class IV patients can’t conduct physical activities without feeling distress, while class I patients can perform daily functions without feeling much or any physical discomfort.
- Be disqualified from receiving revascularization procedures such as coronary artery bypass grafting and percutaneous coronary intervention, two of the main revascularization surgeries, according to Medscape.
What does this study mean to patients?
The study’s significance can’t be understated. The American Heart Association noted that, in 2009, about 1 in 9 people in the U.S. died because of heart disease.
In general, cardiovascular disease, which includes heart failure, accounts for 17 million deaths worldwide each year and is the leading cause of death in the world.
The organization goes on to point out that number is expected to grow to nearly 24 million by the year 2030.
Patients who are diagnosed with heart failure have hearts that fail to pump enough blood throughout their bodies.
As a result, they often experience edema or pulmonary edema and fatigue. The USCF Medical Center also lists severe coughing, poor thinking, dyspnea and expontential weight gain as well as other symptoms.
“For the last 15 years, everyone has been talking about cell therapy and what it can do. These results suggest that it really works,” said Amit N. Patel, M.D., M.S., lead author of the study published in The Lancet and director of Cardiovascular Regenerative Medicine at the University of Utah School of Medicine, according to the University of Utah Health Care.
He continued by saying, “This is the first trial of cell therapy showing that it can have a meaningful impact on the lives of patients with heart failure.”
Where do stem cell researchers go next?
This is a major step forward for scientists, but the question now becomes: Where do they go from here?
While the scientists did say they believe their research is the “largest randomi zed, placebo controlled, double -blinded multi center study” conducted and published thus far on the use of stem cell procedures to treat heart failure, more work needs to be completed.
The researchers indicated their study had “several limitations,” including its sample size. As a phase II study, researchers tested the new treatment on a large group of people, but if they did so at a Phase III level, the sample size would have been even greater.
More so, the U.S. National Library of Medicine indicates that at the Phase III level researchers conduct more extensive research including observing side effects and comparing it to alternative treatments.
Future Phase III and IV studies will likely look to expand on this research while also addressing this study’s limitations.