HOUSTON – (March 24, 2012) – Patients receiving two specific types of stem cells showed a small but significant increase in the ability to pump blood from the left ventricle, the heart’s main pumping chamber to the body, according to research being published early online today in the Journal of the American Medical Association (JAMA).
While researchers found improvement in the left ventricle function, the study did not prove any benefit for treating chronic ischemic heart failure, its main focus.
“This finding impacts the public health of heart disease, shaping the direction of stem cell research in heart failure,” 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). Results are from a multi-center clinical study conducted by the Cardiovascular Cell Therapy Research Network (CCTRN), which is funded by the National Heart, Lung and Blood Institute (NHLBI).
Researchers saw an increase of 3.1 percent in the left ventricle function six months after therapy compared to a 1.6 percent decrease in patients who did not receive the stem cell therapy. Analysis of the trial links improvement to the characteristics of the injected cells.
Moyé and colleagues from the Coordinating Center for Clinical Trials (CCCT) at the UT 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.
According to the JAMA article, cell therapy has emerged as an innovative potential approach for treating patients with advanced ischemic heart disease, including those with heart failure. However, none of the clinical trials performed to date have evaluated specific efficacy measures.
“We were able to analyze the data to determine if patients with symptomatic heart failure could improve the heart’s ability to pump in the presence of these cells,” said Moyé. “The School of Public Health was the communication center and data analysis nervous center for the trial execution and the support center for the clinical research centers.”
Researchers hope the study will pave the way for potential new treatment options and will be important to designing and evaluating future clinical trials. “This is exactly the kind of information we need to move forward with the clinical use of stem cell therapy,” said Emerson Perin, M.D., Ph.D., the study’s lead investigator and director of Clinical Research for Cardiovascular Medicine at Texas Heart Institute.
In this Phase II randomized trial, 92 patients receiving treatment at CCTRN clinical sites were randomly selected to receive stem cell treatment or placebo between April 2009 and April 2011. The average patient age was 63 and was no longer considered a candidate for conventional surgical treatment. Each patient suffered from heart failure and chest pain and the percentage of blood leaving the heart’s main pumping chamber, the left ventricle was less than 45 percent.
“Studies such as these are able to be completed much faster because of the team approach of the Network,” said Sonia Skarlatos, Ph.D., deputy director of the Division of Cardiovascular Sciences at the NHLBI and program director of the Network.
The CCTRN was originally funded by NHLBI in 2007. At that time, it represented the first U.S. federal funding for adult stem cell studies in which patients are treated with stem cells taken from their own bodies. CCTRN includes the Texas Heart Institute, Cleveland Clinic Foundation, University of Florida, Minneapolis Heart Institute Foundation and Vanderbilt University.
- Additional writing by Frank Michel, Texas Heart Institute
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