"Isolating and culturing the stem cells is a relatively straightforward process, and the procedure to inject the stem cells into the heart requires only local anesthesia, so it appears to be all-in-all a promising treatment for patients who have no other options," Mathiasen said.
Although there are other therapies available for patients with ischemic heart disease, these therapies do not help all patients and many patients continue to face fatigue, shortness of breath and accumulation of fluid in the lungs and legs.
Previous studies have shown mesenchymal stromal cells can stimulate repair and regeneration in a variety of tissues, including heart muscle. Mathiasen said in the case of ischemic heart failure, the treatment likely works by facilitating the growth of new blood vessels and new heart muscle.
The study also supports findings from previous, smaller studies, which showed reduced scar tissue in the hearts of patients who received the stem cell treatment, offering additional confirmation that the treatment stimulates the growth of new heart muscle cells.
The researchers will continue to monitor the patients to assess their long-term outcomes.
"We hope that the improvements in heart pump function will not only improve the patients' symptoms but also will result in increased survival for these severely diseased patients," Mathiasen said.
A larger, Phase III clinical trial will be needed to move toward approval of this treatment as a more widely used therapy for ischemic heart failure.
"Our results should offer sufficient evidence that a larger trial is indeed warranted as a next step," Mathiasen said.
|Contact: Beth Casteel|
American College of Cardiology