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A new study in Nature challenges research data that form the scientific basis of clinical trials in which heart attack patients are injected with stem cells to try and regenerate damaged heart tissue.
Researchers at Cincinnati Children's Hospital Medical Center and the Howard Hughes Medical Institute (HHMI), report May 7 that cardiac stem cells used in ongoing clinical trials – which express a protein marker called c-kit – do not regenerate contractile heart muscle cells at high enough rates to justify their use for treatment.
Including collaboration from researchers at Cedars-Sinai Heart Institute in Los Angeles and the University of Minnesota's Lillehei Heart Institute, the study uncovers new evidence in what has become a contentious debate in the field of cardiac regeneration, according to Jeffery Molkentin, PhD, study principal investigator and a cardiovascular molecular biologist and HHMI investigator at the Cincinnati Children's Heart Institute.
"Our data suggest any potential benefit from injecting c-kit-positive cells into the hearts of patients is not because they generate new contractile cells called cardiomyocytes," Molkentin said. "Caution is warranted in further clinical testing of this method until the mechanisms in play here are better defined or we are able to dramatically enhance the potential of these cells to generate cardiomyocytes."
In Mayo Clinic's breakthrough process, stem cells are harvested from a patient's bone marrow. The stem cells undergo a laboratory treatment that guides them into becoming cardiac cells. The treated cells are then injected into the patient's heart in an effort to grow healthy heart tissue.
The study is the first successful demonstration in people of the feasibility and safety of transforming adult stem cells into cardiac cells, Dr. Terzic says.
This discovery could have implications for millions of people. Cardiovascular disease is the leading cause of death worldwide, according to the World Health Organization. In the U.S. alone, about 5.8 million people have heart failure, and the number is growing, according to the National Institutes of Health.