HOUSTON – (Nov. 7, 2012) – Administering stem cells derived from patients' own bone marrow either three or seven days after a heart attack is safe but does not improve heart function six months later, according to a clinical trial supported by the National Institutes of Health (NIH).
The results of the trial, called Transplantation In Myocardial Infarction Evaluation (TIME), mirror a previous related study, LateTIME, which found that such cells (called autologous stem cells) given two to three weeks after a heart attack did not improve heart function. Both TIME and LateTIME were conducted by the Cardiovascular Cell Therapy Research Network (CCTRN), sponsored by the NIH's National Heart, Lung, and Blood Institute.
The findings were presented Nov. 6, 2012, at the American Heart Association 2012 Scientific Sessions in Los Angeles and appeared concurrently in the Journal of the American Medical Association.
"These cells, while safe, were not better than placebo solution in providing benefit," said Lemuel Moyé, III, M.D., Ph.D., principal investigator of the CCTRN 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). "While this one cell type showed little promise, there are several new cell types that are available and we will be studying them. Cell therapy can and likely will play a major role in the treatment of cardiovascular disease in the future."
"This study was extremely valuable even though it did not provide a demonstrated health benefit after six months," said Sonia Skarlatos, Ph.D., deputy director of NHLBI's Division of Cardiovascular Sciences and member of the CCTRN. "Heart stem cell therapy research is still in its infancy, and results from early trials have varied greatly due to differences in the numbers of stem cells injected, the delivery methods used, and the compositions of the study populations. With TIME and LateTIME, we have established both safety and baseline results in two large studies that followed the same procedures for growing and then administering stem cells. This standard will inform the next steps in research on the use of stem cells to repair damaged hearts."
Skarlatos noted that another advantage of the TIME study is that CCTRN is storing samples of the stem cells taken from the participants. Investigators can examine the relationship between people who showed significant improvement during the study and the characteristics of their stem cells. Such a comparison may offer insights on the cell traits that are associated with clinical improvement.
Between July 2008 and February 2011, TIME researchers enrolled 120 volunteers (average age 57, 87.5 percent male) who suffered from moderate to severe impairment in their left ventricles – the part of the heart that pumps oxygen-rich blood to the body – and had undergone stenting procedures following heart attacks. Those selected for the trial were assigned randomly to one of four groups: day three after heart attack stem cell injection, day three after heart attack placebo injection, day seven after heart attack stem cell treatment, or day seven after heart attack placebo treatment. The researchers developed a method of processing and purifying the stem cells to ensure that participants in the stem cell groups received a uniform dose of 150 million cells about eight hours after the cells were harvested from their bone marrow. This ensured that results would not be skewed by differences in the quantity or quality of stem cells administered.
Researchers assessed heart improvement six months after stem cell therapy by measuring the percentage of blood that was pumped out of the left ventricle during each contraction (known as the left-ventricular ejection fraction, or LVEF). The study found no significant differences between the change in LVEF readings at the six-month follow-up in either the day three or the day seven stem cell groups compared with placebo groups or with each other. Every group showed about a three percent improvement in LVEF.
The National Heart, Lung, and Blood Institute (NHLBI) is a component of the National Institutes of Health. NHLBI plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at: www.nhlbi.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
UTHealth: The University of Texas Health Science Center at Houston (UTHealth), the most comprehensive academic health center in The UT System and the U.S. Gulf Coast region, is home to schools of biomedical informatics, biomedical sciences, dentistry, medicine, nursing and public health. UTHealth educates more healthcare professionals than any health-related institution in the State of Texas and features the nation's seventh-largest medical school. It also includes a psychiatric hospital and a growing network of clinics throughout the region. The university's primary teaching hospitals include Memorial Hermann-Texas Medical Center, Children's Memorial Hermann Hospital and Lyndon B. Johnson General Hospital. For more information, visit www.uth.edu.
Journal
JAMA