HOUSTON – (Nov. 15, 2011) - Patients who received bone marrow stem cells (BMCs) two to three weeks following a heart attack showed no significant improvement in left ventricular function after six months, according to a research study by the Cardiovascular Cell Therapy Research Network (CCTRN) funded by the National Heart, Lung, and Blood Institute (NHLBI).
“Our study found that while injecting BMCs did not harm the patient there is no statistically significant improvement in comparison to patients who received an injection of a placebo,” said Lemuel Moyé, III, M.D., Ph.D., corresponding author and professor of biostatistics at The University of Texas School of Public Health, part of The University of Texas Health Science Center at Houston (UTHealth).
Research results are published in the Nov. 16 issue of the Journal of the American Medical Association (JAMA).
In the multi-center clinical trial, called LateTIME, patients received either their own bone marrow stem cells or placebo product to treat their condition two to three weeks after undergoing approved treatments such as stent placements and angioplasty. The stem cells were injected directly into the heart’s left ventricle and patients were followed for six months, when they received a cardiac MRI to access the heart and if there were any improvements.
Moyé and colleagues from the Coordinating Center for Clinical Trials (CCCT) at the School of Public Health were responsible for coordinating and designing the study, in addition to analyzing the data as the Data Coordinating Center for CCTRN. CCTRN is made up of five main clinical research centers: Texas Heart Institute, Cleveland Clinic Foundation, University of Florida, Minneapolis Heart Institute Foundation, and Vanderbilt University.
“We were able to analyze the data to determine if patients were improving over time and whether or not the timing of treatment is more effective than what has previously been tested,” said Moyé. “We were the central nervous center for the trial execution and the support center for the clinical research centers.”
Previous research studies have administered bone marrow stem cells within the first week following heart procedures. Due to a variety of factors, some patients may not be able to receive treatment within the first week, therefore it was important to evaluate delivery several weeks after a heart attack, according to the article.
Researchers plan to continue following patients for another two years.
The study is funded by the NHLBI, which established the CCTRN to develop clinical trials to test the effects of cell therapy on cardiovascular disease.
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