A new study by researchers from Cedars-Sinai Heart Institute demonstrates that stem cell therapy significantly improves long-term condition of patients with severe and end-stage heart failure. The study results have been recently presented at the American College of Cardiology's 65th Annual Scientific Session.
The study was a phase 2 clinical trial for a new stem cell therapy and involved 109 patients with class III or IV heart failure resulting from ischemic cardiomyopathy. 58 patients were randomly assigned to receive stem cell treatment and the remaining 51 patients were assigned to receive a placebo. To date, this is the largest double-blind, placebo-controlled for stem cell treatment of heart failure.
All the patients, including those in the control group, underwent a bone marrow extraction. The doctors collected bone marrow stem cells from the patients, processed them during two weeks to increase the number of desired stem cells, and then injected them back to the patient - right into the patient's heart muscle (in the group receiving stem cell therapy). Those in the control group received placebo.
Patients who received stem cell therapy demonstrated 37% lower rate in adverse outcomes such as deaths, cardiovascular hospitalizations and clinic visits for sudden worsening of heart failure symptoms vs the control group. Among patients who received stem cell therapy, 3.4% died and 37.9% were hospitalized with cardiovascular problems vs 13.7% and 49.0% in the placebo group, respectively, over a 12-month period of follow-up. Patients given stem cell therapy also had, on average, a longer amount of time until their first adverse event. Besides, the study demonstrated overall better quality of life in the group of patients who were given stem cells, although this was not a primary goal of the research.
The researchers are encouraged with the results and to continue their study on larger samples.