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 today at the American Heart Association 2012 Scientific Sessions in Los Angeles and appear 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.
Deborah Mann Lake
Media Hotline: 713-500-3030
Deborah Mann Lake | Source: EurekAlert!
Further information: www.uth.edu
Further Reports about: blood flow > bone marrow > cardiovascular disease > Cardiovascular Science > cell death > cell type > health services > LVEF > medical research > Medical Wellness > NIH > sleep disorder > stem cell therapy > stem cells > UTHealth
More articles from Life Sciences:
Drought makes Borneo’s trees flower at the same time
22.05.2013 | Universität Zürich
Researchers find genetic tie to improved survival time for pulmonary fibrosis
22.05.2013 | University of Colorado Denver
A fried breakfast food popular in Spain provided the inspiration for the development of doughnut-shaped droplets that may provide scientists with a new approach for studying fundamental issues in physics, mathematics and materials.
The doughnut-shaped droplets, a shape known as toroidal, are formed from two dissimilar liquids using a simple rotating stage and an injection needle. About a millimeter in overall size, the droplets are produced individually, their shapes maintained by a surrounding springy material made of polymers.
Droplets in this toroidal shape made ...
Frauhofer FEP will present a novel roll-to-roll manufacturing process for high-barriers and functional films for flexible displays at the SID DisplayWeek 2013 in Vancouver – the International showcase for the Display Industry.
Displays that are flexible and paper thin at the same time?! What might still seem like science fiction will be a major topic at the SID Display Week 2013 that currently takes place in Vancouver in Canada.
High manufacturing cost and a short lifetime are still a major obstacle on ...
University of Würzburg physicists have succeeded in creating a new type of laser.
Its operation principle is completely different from conventional devices, which opens up the possibility of a significantly reduced energy input requirement. The researchers report their work in the current issue of Nature.
It also emits light the waves of which are in phase with one another: the polariton laser, developed ...
Innsbruck physicists led by Rainer Blatt and Peter Zoller experimentally gained a deep insight into the nature of quantum mechanical phase transitions.
They are the first scientists that simulated the competition between two rival dynamical processes at a novel type of transition between two quantum mechanical orders. They have published the results of their work in the journal Nature Physics.
“When water boils, its molecules are released as vapor. We call this ...
Researchers have shown that, by using global positioning systems (GPS) to measure ground deformation caused by a large underwater earthquake, they can provide accurate warning of the resulting tsunami in just a few minutes after the earthquake onset.
For the devastating Japan 2011 event, the team reveals that the analysis of the GPS data and issue of a detailed tsunami alert would have taken no more than three minutes. The results are published on 17 May in Natural Hazards and Earth System Sciences, an open access journal of ...
22.05.2013 | Life Sciences
22.05.2013 | Ecology, The Environment and Conservation
22.05.2013 | Earth Sciences
17.05.2013 | Event News
15.05.2013 | Event News
08.05.2013 | Event News