(RxWiki News) Preliminary clinical trial results suggest that adult stem cells may be able to reverse moderate to severe congestive heart failure.
In a small second phase trial, Mesoblast's revascor, was found to improve functional capacity such as increased walking distance, and reduce deaths and major cardiac events such as heart attacks.
"Consider joining a clinical trial focused on congestive heart failure."
Independent principal investigator Dr. Emerson C. Perin, director of research in cardiovascular medicine and medical director of the Stem Cell Center at the Texas Heart Institute in Houston, said that the findings are the first using stem cell therapy in heart failure patients that demonstrate a positive effect on clinical outcomes, repair of the heart, and functional capacity, the three key parameters in congestive heart failure.
He noted that the promising trial showed that a single 150 million stem cell dose of revascor could significantly cut heart failure hospitalizations and deaths in very sick patients with a poor prognosis despite existing therapies.
During the randomized placebo-controlled trial, 60 patients with moderate to severe congestive heart failure were enrolled. Patients received a revascor injection of 25 million stem cells, 75 million stem cells or 150 million stem cells from a healthy, unrelated donor. There were 15 patients included in each group with an additional 15 participants receiving the usual standard of care acting as a control group. They were followed for a minimum of 12 months, with a mean follow up time of 22 months.
One patient who received revascor died of cardiac causes during follow up as compared to three from a control group. Participants who received injections were found to have a significantly delayed amount of time until their first heart attack, cardiac death or an artery-clearing revascularization procedure, and their overall risk for such events was reduced by 78 percent.
The highest dose of the treatment completely prevented heart failure hospitalizations over an 18-month period, and was accompanied with signs of repair to the heart and improved functional capacity.
Study patients had a diminished capacity to pump blood, and participants had an ejection fracture, or fraction of the blood pumped out of both the left and right ventricles, of 40 percent of less. That number is generally 55 percent in healthy patients.
There were no notable improvements in ejection fracture among patients, though improvements were found on a six-minute walking test, indicating patients were improving.
A third trial phase at the 150 million cell dose will begin late next year, and Metablast expects that the outcomes of the combined trials will be key to potential product approval by the U.S. Food and Drug Administration.
The results were recently presented at the American Heart Association's annual meeting in Orlando, Fla.